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1.  Prevention of Falls and Fall-Related Injuries in Community-Dwelling Seniors 
Executive Summary
In early August 2007, the Medical Advisory Secretariat began work on the Aging in the Community project, an evidence-based review of the literature surrounding healthy aging in the community. The Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the ministry’s newly released Aging at Home Strategy.
After a broad literature review and consultation with experts, the secretariat identified 4 key areas that strongly predict an elderly person’s transition from independent community living to a long-term care home. Evidence-based analyses have been prepared for each of these 4 areas: falls and fall-related injuries, urinary incontinence, dementia, and social isolation. For the first area, falls and fall-related injuries, an economic model is described in a separate report.
Please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html, to review these titles within the Aging in the Community series.
Aging in the Community: Summary of Evidence-Based Analyses
Prevention of Falls and Fall-Related Injuries in Community-Dwelling Seniors: An Evidence-Based Analysis
Behavioural Interventions for Urinary Incontinence in Community-Dwelling Seniors: An Evidence-Based Analysis
Caregiver- and Patient-Directed Interventions for Dementia: An Evidence-Based Analysis
Social Isolation in Community-Dwelling Seniors: An Evidence-Based Analysis
The Falls/Fractures Economic Model in Ontario Residents Aged 65 Years and Over (FEMOR)
Objective
To identify interventions that may be effective in reducing the probability of an elderly person’s falling and/or sustaining a fall-related injury.
Background
Although estimates of fall rates vary widely based on the location, age, and living arrangements of the elderly population, it is estimated that each year approximately 30% of community-dwelling individuals aged 65 and older, and 50% of those aged 85 and older will fall. Of those individuals who fall, 12% to 42% will have a fall-related injury.
Several meta-analyses and cohort studies have identified falls and fall-related injuries as a strong predictor of admission to a long-term care (LTC) home. It has been shown that the risk of LTC home admission is over 5 times higher in seniors who experienced 2 or more falls without injury, and over 10 times higher in seniors who experienced a fall causing serious injury.
Falls result from the interaction of a variety of risk factors that can be both intrinsic and extrinsic. Intrinsic factors are those that pertain to the physical, demographic, and health status of the individual, while extrinsic factors relate to the physical and socio-economic environment. Intrinsic risk factors can be further grouped into psychosocial/demographic risks, medical risks, risks associated with activity level and dependence, and medication risks. Commonly described extrinsic risks are tripping hazards, balance and slip hazards, and vision hazards.
Note: It is recognized that the terms “senior” and “elderly” carry a range of meanings for different audiences; this report generally uses the former, but the terms are treated here as essentially interchangeable.
Evidence-Based Analysis of Effectiveness
Research Question
Since many risk factors for falls are modifiable, what interventions (devices, systems, programs) exist that reduce the risk of falls and/or fall-related injuries for community-dwelling seniors?
Inclusion and Exclusion Criteria
Inclusion Criteria
English language;
published between January 2000 and September 2007;
population of community-dwelling seniors (majority aged 65+); and
randomized controlled trials (RCTs), quasi-experimental trials, systematic reviews, or meta-analyses.
Exclusion Criteria
special populations (e.g., stroke or osteoporosis; however, studies restricted only to women were included);
studies only reporting surrogate outcomes; or
studies whose outcome cannot be extracted for meta-analysis.
Outcomes of Interest
number of fallers, and
number of falls resulting in injury/fracture.
Search Strategy
A search was performed in OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), The Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published between January 2000 and September 2007. Furthermore, all studies included in a 2003 Cochrane review were considered for inclusion in this analysis. Abstracts were reviewed by a single author, and studies meeting the inclusion criteria outlined above were obtained. Studies were grouped based on intervention type, and data on population characteristics, fall outcomes, and study design were extracted. Reference lists were also checked for relevant studies. The quality of the evidence was assessed as high, moderate, low, or very low according to the GRADE methodology.
Summary of Findings
The following 11 interventions were identified in the literature search: exercise programs, vision assessment and referral, cataract surgery, environmental modifications, vitamin D supplementation, vitamin D plus calcium supplementation, hormone replacement therapy (HRT), medication withdrawal, gait-stabilizing devices, hip protectors, and multifactorial interventions.
Exercise programs were stratified into targeted programs where the exercise routine was tailored to the individuals’ needs, and untargeted programs that were identical among subjects. Furthermore, analyses were stratified by exercise program duration (<6 months and ≥6 months) and fall risk of study participants. Similarly, the analyses on the environmental modification studies were stratified by risk. Low-risk study participants had had no fall in the year prior to study entry, while high-risk participants had had at least one fall in the previous year.
A total of 17 studies investigating multifactorial interventions were identified in the literature search. Of these studies, 10 reported results for a high-risk population with previous falls, while 6 reported results for study participants representative of the general population. One study provided stratified results by fall risk, and therefore results from this study were included in each stratified analysis.
Summary of Meta-Analyses of Studies Investigating the Effectiveness of Interventions on the Risk of Falls in Community-Dwelling Seniors*
CI refers to confidence interval; RR, relative risk.
Hazard ratio is reported, because RR was not available.
Summary of Meta-Analyses of Studies Investigating the Effectiveness of Interventions on the Risk of Fall-Related Injuries in Community-Dwelling Seniors*
CI refers to confidence interval; RR, relative risk.
Odds ratio is reported, because RR was not available.
Conclusions
High-quality evidence indicates that long-term exercise programs in mobile seniors and environmental modifications in the homes of frail elderly persons will effectively reduce falls and possibly fall-related injuries in Ontario’s elderly population.
A combination of vitamin D and calcium supplementation in elderly women will help reduce the risk of falls by more than 40%.
The use of outdoor gait-stabilizing devices for mobile seniors during the winter in Ontario may reduce falls and fall-related injuries; however, evidence is limited and more research is required in this area.
While psychotropic medication withdrawal may be an effective method for reducing falls, evidence is limited and long-term compliance has been demonstrated to be difficult to achieve.
Multifactorial interventions in high-risk populations may be effective; however, the effect is only marginally significant, and the quality of evidence is low.
PMCID: PMC3377567  PMID: 23074507
2.  ICT-based system to predict and prevent falls (iStoppFalls): study protocol for an international multicenter randomized controlled trial 
BMC Geriatrics  2014;14:91.
Background
Falls are very common, especially in adults aged 65 years and older. Within the current international European Commission’s Seventh Framework Program (FP7) project ‘iStoppFalls’ an Information and Communication Technology (ICT) based system has been developed to regularly assess a person’s risk of falling in their own home and to deliver an individual and tailored home-based exercise and education program for fall prevention. The primary aims of iStoppFalls are to assess the feasibility and acceptability of the intervention program, and its effectiveness to improve balance, muscle strength and quality of life in older people.
Methods/Design
This international, multicenter study is designed as a single-blinded, two-group randomized controlled trial. A total of 160 community-dwelling older people aged 65 years and older will be recruited in Germany (n = 60), Spain (n = 40), and Australia (n = 60) between November 2013 and May 2014. Participants in the intervention group will conduct a 16-week exercise program using the iStoppFalls system through their television set at home. Participants are encouraged to exercise for a total duration of 180 minutes per week. The training program consists of a variety of balance and strength exercises in the form of video games using exergame technology. Educational material about a healthy lifestyle will be provided to each participant. Final reassessments will be conducted after 16 weeks. The assessments include physical and cognitive tests as well as questionnaires assessing health, fear of falling, quality of life and psychosocial determinants. Falls will be followed up for six months by monthly falls calendars.
Discussion
We hypothesize that the regular use of this newly developed ICT-based system for fall prevention at home is feasible for older people. By using the iStoppFalls sensor-based exercise program, older people are expected to improve in balance and strength outcomes. In addition, the exercise training may have a positive impact on quality of life by reducing the risk of falls. Taken together with expected cognitive improvements, the individual approach of the iStoppFalls program may provide an effective model for fall prevention in older people who prefer to exercise at home.
Trial registration
Australian New Zealand Clinical Trials Registry Trial ID: ACTRN12614000096651.
International Standard Randomised Controlled Trial Number: ISRCTN15932647.
doi:10.1186/1471-2318-14-91
PMCID: PMC4145835  PMID: 25141850
Fall prevention; Fall risk assessment; Older adults; Exercise; Strength; Balance; Exergames; Video games
3.  Protocol for a home-based integrated physical therapy program to reduce falls and improve mobility in people with Parkinson’s disease 
BMC Neurology  2012;12:54.
Background
The high incidence of falls associated with Parkinson’s disease (PD) increases the risk of injuries and immobility and compromises quality of life. Although falls education and strengthening programs have shown some benefit in healthy older people, the ability of physical therapy interventions in home settings to reduce falls and improve mobility in people with Parkinson’s has not been convincingly demonstrated.
Methods/design
180 community living people with PD will be randomly allocated to receive either a home-based integrated rehabilitation program (progressive resistance strength training, movement strategy training and falls education) or a home-based life skills program (control intervention). Both programs comprise one hour of treatment and one hour of structured homework per week over six weeks of home therapy. Blinded assessments occurring before therapy commences, the week after completion of therapy and 12 months following intervention will establish both the immediate and long-term benefits of home-based rehabilitation. The number of falls, number of repeat falls, falls rate and time to first fall will be the primary measures used to quantify outcome. The economic costs associated with injurious falls, and the costs of running the integrated rehabilitation program from a health system perspective will be established. The effects of intervention on motor and global disability and on quality of life will also be examined.
Discussion
This study will provide new evidence on the outcomes and cost effectiveness of home-based movement rehabilitation programs for people living with PD.
Trial registration
The trial is registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12608000390381).
doi:10.1186/1471-2377-12-54
PMCID: PMC3436761  PMID: 22799601
Parkinson’s disease; Accidental falls; Randomized controlled trial; Falls prevention
4.  Effectiveness of a multifactorial falls prevention program in community-dwelling older people when compared to usual care: study protocol for a randomised controlled trial (Prevquedas Brazil) 
BMC Geriatrics  2013;13:27.
Background
Falling in older age is a major public health concern due to its costly and disabling consequences. However very few randomised controlled trials (RCTs) have been conducted in developing countries, in which population ageing is expected to be particularly substantial in coming years. This article describes the design of an RCT to evaluate the effectiveness of a multifactorial falls prevention program in reducing the rate of falls in community-dwelling older people.
Methods/design
Multicentre parallel-group RCT involving 612 community-dwelling men and women aged 60 years and over, who have fallen at least once in the previous year. Participants will be recruited in multiple settings in Sao Paulo, Brazil and will be randomly allocated to a control group or an intervention group. The usual care control group will undergo a fall risk factor assessment and be referred to their clinicians with the risk assessment report so that individual modifiable risk factors can be managed without any specific guidance. The intervention group will receive a 12-week Multifactorial Falls Prevention Program consisting of: an individualised medical management of modifiable risk factors, a group-based, supervised balance training exercise program plus an unsupervised home-based exercise program, an educational/behavioral intervention. Both groups will receive a leaflet containing general information about fall prevention strategies. Primary outcome measures will be the rate of falls and the proportion of fallers recorded by monthly falls diaries and telephone calls over a 12 month period. Secondary outcomes measures will include risk of falling, fall-related self-efficacy score, measures of balance, mobility and strength, fall-related health services use and independence with daily tasks. Data will be analysed using the intention-to-treat principle.The incidence of falls in the intervention and control groups will be calculated and compared using negative binomial regression analysis.
Discussion
This study is the first trial to be conducted in Brazil to evaluate the effectiveness of an intervention to prevent falls. If proven to reduce falls this study has the potential to benefit older adults and assist health care practitioners and policy makers to implement and promote effective falls prevention interventions.
Trial registration
ClinicalTrials.gov (NCT01698580)
doi:10.1186/1471-2318-13-27
PMCID: PMC3606610  PMID: 23497000
Accidental falls; Clinical trial; Aged; Exercise; Education
5.  V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial 
BMC Neurology  2013;13:15.
Background
Recent work has demonstrated that fall risk can be attributed to cognitive as well as motor deficits. Indeed, everyday walking in complex environments utilizes executive function, dual tasking, planning and scanning, all while walking forward. Pilot studies suggest that a multi-modal intervention that combines treadmill training to target motor function and a virtual reality obstacle course to address the cognitive components of fall risk may be used to successfully address the motor-cognitive interactions that are fundamental for fall risk reduction. The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk.
Methods/Design
Three hundred older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (n=100), and patients with Parkinson’s disease (n=100). These three sub-groups will be recruited in order to evaluate the effects of the intervention in people with a range of motor and cognitive deficits. Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training. A falls calendar will be kept by each participant for 6 months after completing the training to assess fall incidence (i.e., the number of falls, multiple falls and falls rate). In addition, we will measure gait under usual and dual task conditions, balance, community mobility, health related quality of life, user satisfaction and cognitive function.
Discussion
This randomized controlled trial will demonstrate the extent to which an intervention that combines treadmill training augmented by virtual reality reduces fall risk, improves mobility and enhances cognitive function in a diverse group of older adults. In addition, the comparison to an active control group that undergoes treadmill training without virtual reality will provide evidence as to the added value of addressing motor cognitive interactions as an integrated unit.
Trial Registration
(NIH)–NCT01732653
doi:10.1186/1471-2377-13-15
PMCID: PMC3602099  PMID: 23388087
Falls; Ageing; Gait; Cognitive function; Prevention; Virtual reality
6.  Exercise therapy for prevention of falls in people with Parkinson's disease: A protocol for a randomised controlled trial and economic evaluation 
BMC Neurology  2009;9:4.
Background
People with Parkinson's disease are twice as likely to be recurrent fallers compared to other older people. As these falls have devastating consequences, there is an urgent need to identify and test innovative interventions with the potential to reduce falls in people with Parkinson's disease. The main objective of this randomised controlled trial is to determine whether fall rates can be reduced in people with Parkinson's disease using exercise targeting three potentially remediable risk factors for falls (reduced balance, reduced leg muscle strength and freezing of gait). In addition we will establish the cost effectiveness of the exercise program from the health provider's perspective.
Methods/Design
230 community-dwelling participants with idiopathic Parkinson's disease will be recruited. Eligible participants will also have a history of falls or be identified as being at risk of falls on assessment. Participants will be randomly allocated to a usual-care control group or an intervention group which will undertake weight-bearing balance and strengthening exercises and use cueing strategies to address freezing of gait. The intervention group will choose between the home-based or support group-based mode of the program. Participants in both groups will receive standardized falls prevention advice. The primary outcome measure will be fall rates. Participants will record falls and medical interventions in a diary for the duration of the 6-month intervention period. Secondary measures include the Parkinson's Disease Falls Risk Score, maximal leg muscle strength, standing balance, the Short Physical Performance Battery, freezing of gait, health and well being, habitual physical activity and positive and negative affect schedule.
Discussion
No adequately powered studies have investigated exercise interventions aimed at reducing falls in people with Parkinson's disease. This trial will determine the effectiveness of the exercise intervention in reducing falls and its cost effectiveness. This pragmatic program, if found to be effective, has the potential to be implemented within existing community services.
Trial registration
The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12608000303347).
doi:10.1186/1471-2377-9-4
PMCID: PMC2637228  PMID: 19161631
7.  The effect of walking on falls in older people: the 'Easy Steps to Health' randomized controlled trial study protocol 
BMC Public Health  2011;11:888.
Background
Falls in older people continue to be a major public health issue in industrialized countries. Extensive research into falls prevention has identified exercise as a proven fall prevention strategy. However, despite over a decade of promoting physical activity, hospitalisation rates due to falls injuries in older people are still increasing. This could be because efforts to increase physical activity amongst older people have been unsuccessful, or the physical activity that older people engage in is insufficient and/or inappropriate. The majority of older people choose walking as their predominant form of exercise. While walking has been shown to lower the risk of many chronic diseases its role in falls prevention remains unclear. This paper outlines the methodology of a study whose aims are to determine: if a home-based walking intervention will reduce the falls rate among healthy but inactive community-dwelling older adults (65 + years) compared to no intervention (usual activity) and; whether such an intervention can improve risk factors for falls, such as balance, strength and reaction time.
Methods/Design
This study uses a randomised controlled trial design.
A total of 484 older people exercising less than 120 minutes per week will be recruited through the community and health care referrals throughout Sydney and neighboring regions. All participants are randomised into either the self-managed walking program group or the health-education waiting list group using a block randomization scheme.
Outcome measures include prospective falls and falls injuries, quality of life, and physical activity levels. A subset of participants (n = 194) will also receive physical performance assessments comprising of tests of dynamic balance, strength, reaction time and lower limb functional status.
Discussion
Certain types of physical activity can reduce the risk of falls. As walking is already the most popular physical activity amongst older people, if walking is shown to reduce falls the public health implications could be enormous. Conversely, if walking does not reduce falls in older people, or even puts older people at greater risk, then health resources targeting falls prevention need to be invested elsewhere.
Trial Registration
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000380099
doi:10.1186/1471-2458-11-888
PMCID: PMC3251253  PMID: 22115340
8.  A best practice fall prevention exercise program to improve balance, strength / power, and psychosocial health in older adults: study protocol for a randomized controlled trial 
BMC Geriatrics  2013;13:105.
Background
With increasing age neuromuscular deficits (e.g., sarcopenia) may result in impaired physical performance and an increased risk for falls. Prominent intrinsic fall-risk factors are age-related decreases in balance and strength / power performance as well as cognitive decline. Additional studies are needed to develop specifically tailored exercise programs for older adults that can easily be implemented into clinical practice. Thus, the objective of the present trial is to assess the effects of a fall prevention program that was developed by an interdisciplinary expert panel on measures of balance, strength / power, body composition, cognition, psychosocial well-being, and falls self-efficacy in healthy older adults. Additionally, the time-related effects of detraining are tested.
Methods/Design
Healthy old people (n = 54) between the age of 65 to 80 years will participate in this trial. The testing protocol comprises tests for the assessment of static / dynamic steady-state balance (i.e., Sharpened Romberg Test, instrumented gait analysis), proactive balance (i.e., Functional Reach Test; Timed Up and Go Test), reactive balance (i.e., perturbation test during bipedal stance; Push and Release Test), strength (i.e., hand grip strength test; Chair Stand Test), and power (i.e., Stair Climb Power Test; countermovement jump). Further, body composition will be analysed using a bioelectrical impedance analysis system. In addition, questionnaires for the assessment of psychosocial (i.e., World Health Organisation Quality of Life Assessment-Bref), cognitive (i.e., Mini Mental State Examination), and fall risk determinants (i.e., Fall Efficacy Scale – International) will be included in the study protocol. Participants will be randomized into two intervention groups or the control / waiting group. After baseline measures, participants in the intervention groups will conduct a 12-week balance and strength / power exercise intervention 3 times per week, with each training session lasting 30 min. (actual training time). One intervention group will complete an extensive supervised training program, while the other intervention group will complete a short version ('3 times 3’) that is home-based and controlled by weekly phone calls. Post-tests will be conducted right after the intervention period. Additionally, detraining effects will be measured 12 weeks after program cessation. The control group / waiting group will not participate in any specific intervention during the experimental period, but will receive the extensive supervised program after the experimental period.
Discussion
It is expected that particularly the supervised combination of balance and strength / power training will improve performance in variables of balance, strength / power, body composition, cognitive function, psychosocial well-being, and falls self-efficacy of older adults. In addition, information regarding fall risk assessment, dose–response-relations, detraining effects, and supervision of training will be provided. Further, training-induced health-relevant changes, such as improved performance in activities of daily living, cognitive function, and quality of life, as well as a reduced risk for falls may help to lower costs in the health care system. Finally, practitioners, therapists, and instructors will be provided with a scientifically evaluated feasible, safe, and easy-to-administer exercise program for fall prevention.
Trial registration
ClinicalTrials.gov Identifier: NCT01906034
doi:10.1186/1471-2318-13-105
PMCID: PMC3852637  PMID: 24106864
Seniors; Fall risk assessment; Resistance training; Postural stability
9.  Behavioural Interventions for Urinary Incontinence in Community-Dwelling Seniors 
Executive Summary
In early August 2007, the Medical Advisory Secretariat began work on the Aging in the Community project, an evidence-based review of the literature surrounding healthy aging in the community. The Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the ministry’s newly released Aging at Home Strategy.
After a broad literature review and consultation with experts, the secretariat identified 4 key areas that strongly predict an elderly person’s transition from independent community living to a long-term care home. Evidence-based analyses have been prepared for each of these 4 areas: falls and fall-related injuries, urinary incontinence, dementia, and social isolation. For the first area, falls and fall-related injuries, an economic model is described in a separate report.
Please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html, to review these titles within the Aging in the Community series.
Aging in the Community: Summary of Evidence-Based Analyses
Prevention of Falls and Fall-Related Injuries in Community-Dwelling Seniors: An Evidence-Based Analysis
Behavioural Interventions for Urinary Incontinence in Community-Dwelling Seniors: An Evidence-Based Analysis
Caregiver- and Patient-Directed Interventions for Dementia: An Evidence-Based Analysis
Social Isolation in Community-Dwelling Seniors: An Evidence-Based Analysis
The Falls/Fractures Economic Model in Ontario Residents Aged 65 Years and Over (FEMOR)
Objective
To assess the effectiveness of behavioural interventions for the treatment and management of urinary incontinence (UI) in community-dwelling seniors.
Clinical Need: Target Population and Condition
Urinary incontinence defined as “the complaint of any involuntary leakage of urine” was identified as 1 of the key predictors in a senior’s transition from independent community living to admission to a long-term care (LTC) home. Urinary incontinence is a health problem that affects a substantial proportion of Ontario’s community-dwelling seniors (and indirectly affects caregivers), impacting their health, functioning, well-being and quality of life. Based on Canadian studies, prevalence estimates range from 9% to 30% for senior men and nearly double from 19% to 55% for senior women. The direct and indirect costs associated with UI are substantial. It is estimated that the total annual costs in Canada are $1.5 billion (Cdn), and that each year a senior living at home will spend $1,000 to $1,500 on incontinence supplies.
Interventions to treat and manage UI can be classified into broad categories which include lifestyle modification, behavioural techniques, medications, devices (e.g., continence pessaries), surgical interventions and adjunctive measures (e.g., absorbent products).
The focus of this review is behavioural interventions, since they are commonly the first line of treatment considered in seniors given that they are the least invasive options with no reported side effects, do not limit future treatment options, and can be applied in combination with other therapies. In addition, many seniors would not be ideal candidates for other types of interventions involving more risk, such as surgical measures.
Note: It is recognized that the terms “senior” and “elderly” carry a range of meanings for different audiences; this report generally uses the former, but the terms are treated here as essentially interchangeable.
Description of Technology/Therapy
Behavioural interventions can be divided into 2 categories according to the target population: caregiver-dependent techniques and patient-directed techniques. Caregiver-dependent techniques (also known as toileting assistance) are targeted at medically complex, frail individuals living at home with the assistance of a caregiver, who tends to be a family member. These seniors may also have cognitive deficits and/or motor deficits. A health care professional trains the senior’s caregiver to deliver an intervention such as prompted voiding, habit retraining, or timed voiding. The health care professional who trains the caregiver is commonly a nurse or a nurse with advanced training in the management of UI, such as a nurse continence advisor (NCA) or a clinical nurse specialist (CNS).
The second category of behavioural interventions consists of patient-directed techniques targeted towards mobile, motivated seniors. Seniors in this population are cognitively able, free from any major physical deficits, and motivated to regain and/or improve their continence. A nurse or a nurse with advanced training in UI management, such as an NCA or CNS, delivers the patient-directed techniques. These are often provided as multicomponent interventions including a combination of bladder training techniques, pelvic floor muscle training (PFMT), education on bladder control strategies, and self-monitoring. Pelvic floor muscle training, defined as a program of repeated pelvic floor muscle contractions taught and supervised by a health care professional, may be employed as part of a multicomponent intervention or in isolation.
Education is a large component of both caregiver-dependent and patient-directed behavioural interventions, and patient and/or caregiver involvement as well as continued practice strongly affect the success of treatment. Incontinence products, which include a large variety of pads and devices for effective containment of urine, may be used in conjunction with behavioural techniques at any point in the patient’s management.
Evidence-Based Analysis Methods
A comprehensive search strategy was used to identify systematic reviews and randomized controlled trials that examined the effectiveness, safety, and cost-effectiveness of caregiver-dependent and patient-directed behavioural interventions for the treatment of UI in community-dwelling seniors (see Appendix 1).
Research Questions
Are caregiver-dependent behavioural interventions effective in improving UI in medically complex, frail community-dwelling seniors with/without cognitive deficits and/or motor deficits?
Are patient-directed behavioural interventions effective in improving UI in mobile, motivated community-dwelling seniors?
Are behavioural interventions delivered by NCAs or CNSs in a clinic setting effective in improving incontinence outcomes in community-dwelling seniors?
Assessment of Quality of Evidence
The quality of the evidence was assessed as high, moderate, low, or very low according to the GRADE methodology and GRADE Working Group. As per GRADE the following definitions apply:
Summary of Findings
Executive Summary Table 1 summarizes the results of the analysis.
The available evidence was limited by considerable variation in study populations and in the type and severity of UI for studies examining both caregiver-directed and patient-directed interventions. The UI literature frequently is limited to reporting subjective outcome measures such as patient observations and symptoms. The primary outcome of interest, admission to a LTC home, was not reported in the UI literature. The number of eligible studies was low, and there were limited data on long-term follow-up.
Summary of Evidence on Behavioural Interventions for the Treatment of Urinary Incontinence in Community-Dwelling Seniors
Prompted voiding
Habit retraining
Timed voiding
Bladder training
PFMT (with or without biofeedback)
Bladder control strategies
Education
Self-monitoring
CI refers to confidence interval; CNS, clinical nurse specialist; NCA, nurse continence advisor; PFMT, pelvic floor muscle training; RCT, randomized controlled trial; WMD, weighted mean difference; UI, urinary incontinence.
Economic Analysis
A budget impact analysis was conducted to forecast costs for caregiver-dependent and patient-directed multicomponent behavioural techniques delivered by NCAs, and PFMT alone delivered by physiotherapists. All costs are reported in 2008 Canadian dollars. Based on epidemiological data, published medical literature and clinical expert opinion, the annual cost of caregiver-dependent behavioural techniques was estimated to be $9.2 M, while the annual costs of patient-directed behavioural techniques delivered by either an NCA or physiotherapist were estimated to be $25.5 M and $36.1 M, respectively. Estimates will vary if the underlying assumptions are changed.
Currently, the province of Ontario absorbs the cost of NCAs (available through the 42 Community Care Access Centres across the province) in the home setting. The 2007 Incontinence Care in the Community Report estimated that the total cost being absorbed by the public system of providing continence care in the home is $19.5 M in Ontario. This cost estimate included resources such as personnel, communication with physicians, record keeping and product costs. Clinic costs were not included in this estimation because currently these come out of the global budget of the respective hospital and very few continence clinics actually exist in the province. The budget impact analysis factored in a cost for the clinic setting, assuming that the public system would absorb the cost with this new model of community care.
Considerations for Ontario Health System
An expert panel on aging in the community met on 3 occasions from January to May 2008, and in part, discussed treatment of UI in seniors in Ontario with a focus on caregiver-dependent and patient-directed behavioural interventions. In particular, the panel discussed how treatment for UI is made available to seniors in Ontario and who provides the service. Some of the major themes arising from the discussions included:
Services/interventions that currently exist in Ontario offering behavioural interventions to treat UI are not consistent. There is a lack of consistency in how seniors access services for treatment of UI, who manages patients and what treatment patients receive.
Help-seeking behaviours are important to consider when designing optimal service delivery methods.
There is considerable social stigma associated with UI and therefore there is a need for public education and an awareness campaign.
The cost of incontinent supplies and the availability of NCAs were highlighted.
Conclusions
There is moderate-quality evidence that the following interventions are effective in improving UI in mobile motivated seniors:
Multicomponent behavioural interventions including a combination of bladder training techniques, PFMT (with or without biofeedback), education on bladder control strategies and self-monitoring techniques.
Pelvic floor muscle training alone.
There is moderate quality evidence that when behavioural interventions are led by NCAs or CNSs in a clinic setting, they are effective in improving UI in seniors.
There is limited low-quality evidence that prompted voiding may be effective in medically complex, frail seniors with motivated caregivers.
There is insufficient evidence for the following interventions in medically complex, frail seniors with motivated caregivers:
habit retraining, and
timed voiding.
PMCID: PMC3377527  PMID: 23074508
10.  A randomised controlled trial of a home based exercise programme to reduce the risk of falling among people with Parkinson's disease 
Objective
To evaluate the effectiveness of a personalised home programme of exercises and strategies for repeat fallers with Parkinson's disease (PD).
Method
Patients with a confirmed diagnosis of idiopathic PD, independently mobile, living at home in the community, experiencing more than one fall in the previous 12 months and with intact gross cognitive function were invited to participate in this randomised controlled trial. Usual care was compared with a personalised 6 week, home based exercise and strategy programme. The primary outcomes were rates of falling at 8 weeks and 6 months. Whether participants had repeat fallen, nearly fallen or experienced injurious falls were also examined. Functional Reach, the Berg Balance Test, PD Self‐assessment Scale and the Euro Quol were rated by a blinded assessor.
Results
Participants were randomised to the exercise (n = 70) and control (n = 72) groups. There was a consistent trend towards lower fall rates in the exercise group at both 8 weeks and 6 months and lower rates of injurious falls needing medical attention at 6 months. Lower rates of repeat near falling were evident for the exercise group at 8 weeks (p = 0.004) and 6 months (p = 0.007). There was a positive effect of exercises at 6 months on Functional Reach (p = 0.009) and quality of life (p = 0.033). No significant differences were found on other secondary outcomes measures.
Conclusion
There was a trend towards a reduction in fall events and injurious falls with a positive effect of exercises on near falls and quality of life.
doi:10.1136/jnnp.2006.099333
PMCID: PMC2117667  PMID: 17119004
11.  Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial 
Objectives To determine whether a lifestyle integrated approach to balance and strength training is effective in reducing the rate of falls in older, high risk people living at home.
Design Three arm, randomised parallel trial; assessments at baseline and after six and 12 months. Randomisation done by computer generated random blocks, stratified by sex and fall history and concealed by an independent secure website.
Setting Residents in metropolitan Sydney, Australia.
Participants Participants aged 70 years or older who had two or more falls or one injurious fall in past 12 months, recruited from Veteran’s Affairs databases and general practice databases. Exclusion criteria were moderate to severe cognitive problems, inability to ambulate independently, neurological conditions that severely influenced gait and mobility, resident in a nursing home or hostel, or any unstable or terminal illness that would affect ability to do exercises.
Interventions Three home based interventions: Lifestyle integrated Functional Exercise (LiFE) approach (n=107; taught principles of balance and strength training and integrated selected activities into everyday routines), structured programme (n=105; exercises for balance and lower limb strength, done three times a week), sham control programme (n=105; gentle exercise). LiFE and structured groups received five sessions with two booster visits and two phone calls; controls received three home visits and six phone calls. Assessments made at baseline and after six and 12 months.
Main outcome measures Primary measure: rate of falls over 12 months, collected by self report. Secondary measures: static and dynamic balance; ankle, knee and hip strength; balance self efficacy; daily living activities; participation; habitual physical activity; quality of life; energy expenditure; body mass index; and fat free mass.
Results After 12 months’ follow-up, we recorded 172, 193, and 224 falls in the LiFE, structured exercise, and control groups, respectively. The overall incidence of falls in the LiFE programme was 1.66 per person years, compared with 1.90 in the structured programme and 2.28 in the control group. We saw a significant reduction of 31% in the rate of falls for the LiFE programme compared with controls (incidence rate ratio 0.69 (95% confidence interval 0.48 to 0.99)); the corresponding difference between the structured group and controls was non-significant (0.81 (0.56 to 1.17)). Static balance on an eight level hierarchy scale, ankle strength, function, and participation were significantly better in the LiFE group than in controls. LiFE and structured groups had a significant and moderate improvement in dynamic balance, compared with controls.
Conclusions The LiFE programme provides an alternative to traditional exercise to consider for fall prevention. Functional based exercise should be a focus for interventions to protect older, high risk people from falling and to improve and maintain functional capacity.
Trial registration Australia and New Zealand Clinical Trials Registry 12606000025538.
doi:10.1136/bmj.e4547
PMCID: PMC3413733  PMID: 22872695
12.  Caregiver- and Patient-Directed Interventions for Dementia 
Executive Summary
In early August 2007, the Medical Advisory Secretariat began work on the Aging in the Community project, an evidence-based review of the literature surrounding healthy aging in the community. The Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the ministry’s newly released Aging at Home Strategy.
After a broad literature review and consultation with experts, the secretariat identified 4 key areas that strongly predict an elderly person’s transition from independent community living to a long-term care home. Evidence-based analyses have been prepared for each of these 4 areas: falls and fall-related injuries, urinary incontinence, dementia, and social isolation. For the first area, falls and fall-related injuries, an economic model is described in a separate report.
Please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html, to review these titles within the Aging in the Community series.
Aging in the Community: Summary of Evidence-Based Analyses
Prevention of Falls and Fall-Related Injuries in Community-Dwelling Seniors: An Evidence-Based Analysis
Behavioural Interventions for Urinary Incontinence in Community-Dwelling Seniors: An Evidence-Based Analysis
Caregiver- and Patient-Directed Interventions for Dementia: An Evidence-Based Analysis
Social Isolation in Community-Dwelling Seniors: An Evidence-Based Analysis
The Falls/Fractures Economic Model in Ontario Residents Aged 65 Years and Over (FEMOR)
This report features the evidence-based analysis on caregiver- and patient-directed interventions for dementia and is broken down into 4 sections:
Introduction
Caregiver-Directed Interventions for Dementia
Patient-Directed Interventions for Dementia
Economic Analysis of Caregiver- and Patient-Directed Interventions for Dementia
Caregiver-Directed Interventions for Dementia
Objective
To identify interventions that may be effective in supporting the well-being of unpaid caregivers of seniors with dementia living in the community.
Clinical Need: Target Population and Condition
Dementia is a progressive and largely irreversible syndrome that is characterized by a loss of cognitive function severe enough to impact social or occupational functioning. The components of cognitive function affected include memory and learning, attention, concentration and orientation, problem-solving, calculation, language, and geographic orientation. Dementia was identified as one of the key predictors in a senior’s transition from independent community living to admission to a long-term care (LTC) home, in that approximately 90% of individuals diagnosed with dementia will be institutionalized before death. In addition, cognitive decline linked to dementia is one of the most commonly cited reasons for institutionalization.
Prevalence estimates of dementia in the Ontario population have largely been extrapolated from the Canadian Study of Health and Aging conducted in 1991. Based on these estimates, it is projected that there will be approximately 165,000 dementia cases in Ontario in the year 2008, and by 2010 the number of cases will increase by nearly 17% over 2005 levels. By 2020 the number of cases is expected to increase by nearly 55%, due to a rise in the number of people in the age categories with the highest prevalence (85+). With the increase in the aging population, dementia will continue to have a significant economic impact on the Canadian health care system. In 1991, the total costs associated with dementia in Canada were $3.9 billion (Cdn) with $2.18 billion coming from LTC.
Caregivers play a crucial role in the management of individuals with dementia because of the high level of dependency and morbidity associated with the condition. It has been documented that a greater demand is faced by dementia caregivers compared with caregivers of persons with other chronic diseases. The increased burden of caregiving contributes to a host of chronic health problems seen among many informal caregivers of persons with dementia. Much of this burden results from managing the behavioural and psychological symptoms of dementia (BPSD), which have been established as a predictor of institutionalization for elderly patients with dementia.
It is recognized that for some patients with dementia, an LTC facility can provide the most appropriate care; however, many patients move into LTC unnecessarily. For individuals with dementia to remain in the community longer, caregivers require many types of formal and informal support services to alleviate the stress of caregiving. These include both respite care and psychosocial interventions. Psychosocial interventions encompass a broad range of interventions such as psychoeducational interventions, counseling, supportive therapy, and behavioural interventions.
Assuming that 50% of persons with dementia live in the community, a conservative estimate of the number of informal caregivers in Ontario is 82,500. Accounting for the fact that 29% of people with dementia live alone, this leaves a remaining estimate of 58,575 Ontarians providing care for a person with dementia with whom they reside.
Description of Interventions
The 2 main categories of caregiver-directed interventions examined in this review are respite care and psychosocial interventions. Respite care is defined as a break or relief for the caregiver. In most cases, respite is provided in the home, through day programs, or at institutions (usually 30 days or less). Depending on a caregiver’s needs, respite services will vary in delivery and duration. Respite care is carried out by a variety of individuals, including paid staff, volunteers, family, or friends.
Psychosocial interventions encompass a broad range of interventions and have been classified in various ways in the literature. This review will examine educational, behavioural, dementia-specific, supportive, and coping interventions. The analysis focuses on behavioural interventions, that is, those designed to help the caregiver manage BPSD. As described earlier, BPSD are one of the most challenging aspects of caring for a senior with dementia, causing an increase in caregiver burden. The analysis also examines multicomponent interventions, which include at least 2 of the above-mentioned interventions.
Methods of Evidence-Based Analysis
A comprehensive search strategy was used to identify systematic reviews and randomized controlled trials (RCTs) that examined the effectiveness of interventions for caregivers of dementia patients.
Questions
Section 2.1
Are respite care services effective in supporting the well-being of unpaid caregivers of seniors with dementia in the community?
Do respite care services impact on rates of institutionalization of these seniors?
Section 2.2
Which psychosocial interventions are effective in supporting the well-being of unpaid caregivers of seniors with dementia in the community?
Which interventions reduce the risk for institutionalization of seniors with dementia?
Outcomes of Interest
any quantitative measure of caregiver psychological health, including caregiver burden, depression, quality of life, well-being, strain, mastery (taking control of one’s situation), reactivity to behaviour problems, etc.;
rate of institutionalization; and
cost-effectiveness.
Assessment of Quality of Evidence
The quality of the evidence was assessed as High, Moderate, Low, or Very low according to the GRADE methodology and GRADE Working Group. As per GRADE the following definitions apply:
Summary of Findings
Conclusions in Table 1 are drawn from Sections 2.1 and 2.2 of the report.
Summary of Conclusions on Caregiver-Directed Interventions
There is limited evidence from RCTs that respite care is effective in improving outcomes for those caring for seniors with dementia.
There is considerable qualitative evidence of the perceived benefits of respite care.
Respite care is known as one of the key formal support services for alleviating caregiver burden in those caring for dementia patients.
Respite care services need to be tailored to individual caregiver needs as there are vast differences among caregivers and patients with dementia (severity, type of dementia, amount of informal/formal support available, housing situation, etc.)
There is moderate- to high-quality evidence that individual behavioural interventions (≥ 6 sessions), directed towards the caregiver (or combined with the patient) are effective in improving psychological health in dementia caregivers.
There is moderate- to high-quality evidence that multicomponent interventions improve caregiver psychosocial health and may affect rates of institutionalization of dementia patients.
RCT indicates randomized controlled trial.
Patient-Directed Interventions for Dementia
Objective
The section on patient-directed interventions for dementia is broken down into 4 subsections with the following questions:
3.1 Physical Exercise for Seniors with Dementia – Secondary Prevention
What is the effectiveness of physical exercise for the improvement or maintenance of basic activities of daily living (ADLs), such as eating, bathing, toileting, and functional ability, in seniors with mild to moderate dementia?
3.2 Nonpharmacologic and Nonexercise Interventions to Improve Cognitive Functioning in Seniors With Dementia – Secondary Prevention
What is the effectiveness of nonpharmacologic interventions to improve cognitive functioning in seniors with mild to moderate dementia?
3.3 Physical Exercise for Delaying the Onset of Dementia – Primary Prevention
Can exercise decrease the risk of subsequent cognitive decline/dementia?
3.4 Cognitive Interventions for Delaying the Onset of Dementia – Primary Prevention
Does cognitive training decrease the risk of cognitive impairment, deterioration in the performance of basic ADLs or instrumental activities of daily living (IADLs),1 or incidence of dementia in seniors with good cognitive and physical functioning?
Clinical Need: Target Population and Condition
Secondary Prevention2
Exercise
Physical deterioration is linked to dementia. This is thought to be due to reduced muscle mass leading to decreased activity levels and muscle atrophy, increasing the potential for unsafe mobility while performing basic ADLs such as eating, bathing, toileting, and functional ability.
Improved physical conditioning for seniors with dementia may extend their independent mobility and maintain performance of ADL.
Nonpharmacologic and Nonexercise Interventions
Cognitive impairments, including memory problems, are a defining feature of dementia. These impairments can lead to anxiety, depression, and withdrawal from activities. The impact of these cognitive problems on daily activities increases pressure on caregivers.
Cognitive interventions aim to improve these impairments in people with mild to moderate dementia.
Primary Prevention3
Exercise
Various vascular risk factors have been found to contribute to the development of dementia (e.g., hypertension, hypercholesterolemia, diabetes, overweight).
Physical exercise is important in promoting overall and vascular health. However, it is unclear whether physical exercise can decrease the risk of cognitive decline/dementia.
Nonpharmacologic and Nonexercise Interventions
Having more years of education (i.e., a higher cognitive reserve) is associated with a lower prevalence of dementia in crossectional population-based studies and a lower incidence of dementia in cohorts followed longitudinally. However, it is unclear whether cognitive training can increase cognitive reserve or decrease the risk of cognitive impairment, prevent or delay deterioration in the performance of ADLs or IADLs or reduce the incidence of dementia.
Description of Interventions
Physical exercise and nonpharmacologic/nonexercise interventions (e.g., cognitive training) for the primary and secondary prevention of dementia are assessed in this review.
Evidence-Based Analysis Methods
A comprehensive search strategy was used to identify systematic reviews and RCTs that examined the effectiveness, safety and cost effectiveness of exercise and cognitive interventions for the primary and secondary prevention of dementia.
Questions
Section 3.1: What is the effectiveness of physical exercise for the improvement or maintenance of ADLs in seniors with mild to moderate dementia?
Section 3.2: What is the effectiveness of nonpharmacologic/nonexercise interventions to improve cognitive functioning in seniors with mild to moderate dementia?
Section 3.3: Can exercise decrease the risk of subsequent cognitive decline/dementia?
Section 3.4: Does cognitive training decrease the risk of cognitive impairment, prevent or delay deterioration in the performance of ADLs or IADLs, or reduce the incidence of dementia in seniors with good cognitive and physical functioning?
Assessment of Quality of Evidence
The quality of the evidence was assessed as High, Moderate, Low, or Very low according to the GRADE methodology. As per GRADE the following definitions apply:
Summary of Findings
Table 2 summarizes the conclusions from Sections 3.1 through 3.4.
Summary of Conclusions on Patient-Directed Interventions*
Previous systematic review indicated that “cognitive training” is not effective in patients with dementia.
A recent RCT suggests that CST (up to 7 weeks) is effective for improving cognitive function and quality of life in patients with dementia.
Regular leisure time physical activity in midlife is associated with a reduced risk of dementia in later life (mean follow-up 21 years).
Regular physical activity in seniors is associated with a reduced risk of cognitive decline (mean follow-up 2 years).
Regular physical activity in seniors is associated with a reduced risk of dementia (mean follow-up 6–7 years).
Evidence that cognitive training for specific functions (memory, reasoning, and speed of processing) produces improvements in these specific domains.
Limited inconclusive evidence that cognitive training can offset deterioration in the performance of self-reported IADL scores and performance assessments.
1° indicates primary; 2°, secondary; CST, cognitive stimulation therapy; IADL, instrumental activities of daily living; RCT, randomized controlled trial.
Benefit/Risk Analysis
As per the GRADE Working Group, the overall recommendations consider 4 main factors:
the trade-offs, taking into account the estimated size of the effect for the main outcome, the confidence limits around those estimates, and the relative value placed on the outcome;
the quality of the evidence;
translation of the evidence into practice in a specific setting, taking into consideration important factors that could be expected to modify the size of the expected effects such as proximity to a hospital or availability of necessary expertise; and
uncertainty about the baseline risk for the population of interest.
The GRADE Working Group also recommends that incremental costs of health care alternatives should be considered explicitly alongside the expected health benefits and harms. Recommendations rely on judgments about the value of the incremental health benefits in relation to the incremental costs. The last column in Table 3 reflects the overall trade-off between benefits and harms (adverse events) and incorporates any risk/uncertainty (cost-effectiveness).
Overall Summary Statement of the Benefit and Risk for Patient-Directed Interventions*
Economic Analysis
Budget Impact Analysis of Effective Interventions for Dementia
Caregiver-directed behavioural techniques and patient-directed exercise programs were found to be effective when assessing mild to moderate dementia outcomes in seniors living in the community. Therefore, an annual budget impact was calculated based on eligible seniors in the community with mild and moderate dementia and their respective caregivers who were willing to participate in interventional home sessions. Table 4 describes the annual budget impact for these interventions.
Annual Budget Impact (2008 Canadian Dollars)
Assumed 7% prevalence of dementia aged 65+ in Ontario.
Assumed 8 weekly sessions plus 4 monthly phone calls.
Assumed 12 weekly sessions plus biweekly sessions thereafter (total of 20).
Assumed 2 sessions per week for first 5 weeks. Assumed 90% of seniors in the community with dementia have mild to moderate disease. Assumed 4.5% of seniors 65+ are in long-term care, and the remainder are in the community. Assumed a rate of participation of 60% for both patients and caregivers and of 41% for patient-directed exercise. Assumed 100% compliance since intervention administered at the home. Cost for trained staff from Ministry of Health and Long-Term Care data source. Assumed cost of personal support worker to be equivalent to in-home support. Cost for recreation therapist from Alberta government Website.
Note: This budget impact analysis was calculated for the first year after introducing the interventions from the Ministry of Health and Long-Term Care perspective using prevalence data only. Prevalence estimates are for seniors in the community with mild to moderate dementia and their respective caregivers who are willing to participate in an interventional session administered at the home setting. Incidence and mortality rates were not factored in. Current expenditures in the province are unknown and therefore were not included in the analysis. Numbers may change based on population trends, rate of intervention uptake, trends in current programs in place in the province, and assumptions on costs. The number of patients was based on patients likely to access these interventions in Ontario based on assumptions stated below from the literature. An expert panel confirmed resource consumption.
PMCID: PMC3377513  PMID: 23074509
13.  Trunk muscle exercises as a means of improving postural stability in people with Parkinson's disease: a protocol for a randomised controlled trial 
BMJ Open  2014;4(12):e006095.
Introduction
Exercise has been shown to improve clinical measures of strength, balance and mobility, and in some cases, has improved symptoms of tremor and rigidity in people with Parkinson's disease (PD). However, to date, no research has examined whether improvements in trunk control can remedy deficits in dynamic postural stability in this population. The proposed randomised controlled trial aims to establish whether a 12-week exercise programme aimed at improving dynamic postural stability in people with PD; (1) is more effective than education; (2) is more effective when training frequency is increased; and (3) provides greater long-term benefits than education.
Methods/design
Forty-five community-dwelling individuals diagnosed with idiopathic PD with a falls history will be recruited. Participants will complete baseline assessments including tests of cognition, vision, disease severity, fear of falling, mobility and quality of life. Additionally, participants will complete a series of standing balance tasks to evaluate static postural stability, while dynamic postural control will be measured during walking using head and trunk-mounted three-dimensional accelerometers. Following baseline testing, participants will be randomly-assigned to one of three intervention groups, who will receive either exercise once per week, exercise 3 days/week, or education. Participants will repeat the same battery of tests conducted at baseline after the 12-week intervention and again following a further 12-week sustainability period.
Discussion
This study has the potential to show that low-intensity and progressive trunk exercises can provide a non-invasive and effective means for maintaining or improving postural stability for people with PD. Importantly, if the programme is noted to be effective, it could be easily performed by patients within their home environment or under the guidance of available allied health professionals.
Trial registration number
The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613001175763).
doi:10.1136/bmjopen-2014-006095
PMCID: PMC4281545  PMID: 25552609
PUBLIC HEALTH
14.  Support and assessment for fall emergency referrals (SAFER 2) research protocol: cluster randomised trial of the clinical and cost effectiveness of new protocols for emergency ambulance paramedics to assess and refer to appropriate community-based care 
BMJ Open  2012;2(6):e002169.
Introduction
Emergency calls to ambulance services are frequent for older people who have fallen, but ambulance crews often leave patients at the scene without ongoing care. Evidence shows that when left at home with no further support older people often experience subsequent falls which result in injury and emergency-department attendances. SAFER 2 is an evaluation of a new clinical protocol which allows paramedics to assess and refer older people who have fallen, and do not need hospital care, to community-based falls services. In this protocol paper, we report methods and progress during trial implementation. SAFER 2 is recruiting patients through three ambulance services. A successful trial will provide robust evidence about the value of this new model of care, and enable ambulance services to use resources efficiently.
Design
Pragmatic cluster randomised trial.
Methods and analysis
We randomly allocated 25 participating ambulance stations (clusters) in three services to intervention or control group. Intervention paramedics received training and clinical protocols for assessing and referring older people who have fallen to community-based falls services when appropriate, while control paramedics deliver care as usual. Patients are eligible for the trial if they are aged 65 or over; resident in a participating falls service catchment area; and attended by a trial paramedic following an emergency call coded as a fall without priority symptoms. The principal outcome is the rate of further emergency contacts (or death), for any cause and for falls. Secondary outcomes include further falls, health-related quality of life, ‘fear of falling’, patient satisfaction reported by participants through postal questionnaires at 1 and 6 months, and quality and pathways of care at the index incident. We shall compare National Health Service (NHS) and patient/carer costs between intervention and control groups and estimate quality-adjusted life years (QALYs) gained from the intervention and thus incremental cost per QALY. We shall estimate wider system effects on key-performance indicators. We shall interview 60 intervention patients, and conduct focus groups with contributing NHS staff to explore their experiences of the assessment and referral service. We shall analyse quantitative trial data by ‘treatment allocated’; and qualitative data using content analysis.
Ethics and dissemination
The Research Ethics Committee for Wales gave ethical approval and each participating centre gave NHS Research and Development approval. We shall disseminate study findings through peer-reviewed publications and conference presentations.
Trial Registration: ISRCTN 60481756
doi:10.1136/bmjopen-2012-002169
PMCID: PMC3533098  PMID: 23148348
Accident & Emergency Medicine; Injury Prevention
15.  Efficacy of a multifaceted podiatry intervention to improve balance and prevent falls in older people: study protocol for a randomised trial 
BMC Geriatrics  2008;8:30.
Background
Falls in older people are a major public health problem, with at least one in three people aged over 65 years falling each year. There is increasing evidence that foot problems and inappropriate footwear increase the risk of falls, however no studies have been undertaken to determine whether modifying these risk factors decreases the risk of falling. This article describes the design of a randomised trial to evaluate the efficacy of a multifaceted podiatry intervention to reduce foot pain, improve balance, and reduce falls in older people.
Methods
Three hundred community-dwelling men and women aged 65 years and over with current foot pain and an increased risk of falling will be randomly allocated to a control or intervention group. The "usual cae" control group will receive routine podiatry (i.e. nail care and callus debridement). The intervention group will receive usual care plus a multifaceted podiatry intervention consisting of: (i) prefabricated insoles customised to accommodate plantar lesions; (ii) footwear advice and assistance with the purchase of new footwear if current footwear is inappropriate; (iii) a home-based exercise program to strengthen foot and ankle muscles; and (iv) a falls prevention education booklet. Primary outcome measures will be the number of fallers, number of multiple fallers and the falls rate recorded by a falls diary over a 12 month period. Secondary outcome measures assessed six months after baseline will include the Medical Outcomes Study Short Form 12 (SF-12), the Manchester Foot Pain and Disability Index, the Falls Efficacy Scale International, and a series of balance and functional tests. Data will be analysed using the intention to treat principle.
Discussion
This study is the first randomised trial to evaluate the efficacy of podiatry in improving balance and preventing falls. The trial has been pragmatically designed to ensure that the findings can be generalised to clinical practice. If found to be effective, the multifaceted podiatry intervention will be a unique addition to common falls prevention strategies already in use.
Trial registration
Australian New Zealand Clinical Trials Registry: ACTRN12608000065392
doi:10.1186/1471-2318-8-30
PMCID: PMC2613884  PMID: 19025668
16.  A comparison of Irish set dancing and exercises for people with Parkinson’s disease: A phase II feasibility study 
BMC Geriatrics  2013;13:54.
Background
People with idiopathic Parkinson’s disease (PD) frequently have low activity levels, poor mobility and reduced quality of life. Although increased physical activity may improve mobility, balance and wellbeing, adherence to exercises and activity programs over the longer term can be challenging, particularly for older people with progressive neurological conditions such as PD. Physical activities that are engaging and enjoyable, such as dancing, might enhance adherence over the long term. The objective of this study was to evaluate the feasibility of a randomized controlled trial of Irish set dancing compared with routine physiotherapy for people with mild to moderately severe PD.
Methods
Twenty-four people with idiopathic PD referred for movement rehabilitation were randomized to receive standard physiotherapy exercises or Irish set dancing classes once per week plus a weekly home program for 6 months (12 in each group). The feasibility and safety of the proposed RCT protocol was the main focus of this evaluation. The primary outcome was motor disability measured by the motor component of the UPDRS, which was assessed prior to and after therapy by trained assessors blinded to group assignment. The Timed Up and Go, the Berg Balance Scale and the modified Freezing of Gait Questionnaire were secondary measures. Quality of life of the people with PD was evaluated using the PDQ-39.
Results
Both the Irish set dancing and physiotherapy exercise program were shown to be feasible and safe. There were no differences between groups in the rate of adverse events such as falls, serious injuries, death or rates of admission to hospital. The physiotherapists who provided usual care remained blind to group allocation, with no change in their standard clinical practice. Compliance and adherence to both the exercise and dance programs were very high and attrition rates were low over the 6 months of therapy. Although improvements were made in both groups, the dance group showed superior results to standard physiotherapy in relation to freezing of gait, balance and motor disability.
Conclusions
Irish dancing and physiotherapy were both safe and feasible in this sample from Venice, with good adherence over a comparatively long time period of 6 months. A larger multi-centre trial is now warranted to establish whether Irish set dancing is more effective than routine physiotherapy for enhancing mobility, balance and quality of life in people living with idiopathic PD.
Trial registration
EudraCT number 2012-005769-11
doi:10.1186/1471-2318-13-54
PMCID: PMC3685562  PMID: 23731986
Parkinson’s disease; Dancing; Rehabilitation; Exercise therapy; Balance; Randomized controlled trial; Geriatrics
17.  Evaluation of the effect of patient education on rates of falls in older hospital patients: Description of a randomised controlled trial 
BMC Geriatrics  2009;9:14.
Background
Accidental falls by older patients in hospital are one of the most commonly reported adverse events. Falls after discharge are also common. These falls have enormous physical, psychological and social consequences for older patients, including serious physical injury and reduced quality of life, and are also a source of substantial cost to health systems worldwide. There have been a limited number of randomised controlled trials, mainly using multifactorial interventions, aiming to prevent older people falling whilst inpatients. Trials to date have produced conflicting results and recent meta-analyses highlight that there is still insufficient evidence to clearly identify which interventions may reduce the rate of falls, and falls related injuries, in this population.
Methods and design
A prospective randomised controlled trial (n = 1206) is being conducted at two hospitals in Australia. Patients are eligible to be included in the trial if they are over 60 years of age and they, or their family or guardian, give written consent. Participants are randomised into three groups. The control group continues to receive usual care. Both intervention groups receive a specifically designed patient education intervention on minimising falls in addition to usual care. The education is delivered by Digital Video Disc (DVD) and written workbook and aims to promote falls prevention activities by participants. One of the intervention groups also receives follow up education training visits by a health professional. Blinded assessors conduct baseline and discharge assessments and follow up participants for 6 months after discharge. The primary outcome measure is falls by participants in hospital. Secondary outcome measures include falls at home after discharge, knowledge of falls prevention strategies and motivation to engage in falls prevention activities after discharge. All analyses will be based on intention to treat principle.
Discussion
This trial will examine the effect of a single intervention (specifically designed patient education) on rates of falls in older patients in hospital and after discharge. The results will provide robust recommendations for clinicians and researchers about the role of patient education in this population. The study has the potential to identify a new intervention that may reduce rates of falls in older hospital patients and could be readily duplicated and applied in a wide range of clinical settings.
Trial Registration
ACTRN12608000015347
doi:10.1186/1471-2318-9-14
PMCID: PMC2688498  PMID: 19393046
18.  Can a tailored exercise and home hazard reduction program reduce the rate of falls in community dwelling older people with cognitive impairment: protocol paper for the i-FOCIS randomised controlled trial 
BMC Geriatrics  2014;14:89.
Background
The rate of falls in community dwelling older people with cognitive impairment (CI) is twice that of a cognitively intact population, with almost two thirds of people with CI falling annually. Studies indicate that exercise involving balance and/or a home hazard reduction program are effective in preventing falls in cognitively intact older people. However the potential benefit of these interventions in reducing falls in people with CI has not been established.
This randomised controlled trial will determine whether a tailored exercise and home hazard reduction program can reduce the rate of falls in community dwelling older people with CI. We will determine whether the intervention has beneficial effects on a range of physical and psychological outcome measures as well as quality of life of participants and their carers. A health economic analysis examining the cost and potential benefits of the program will also be undertaken.
Methods and design
Three hundred and sixty people aged 65 years or older living in the community with CI will be recruited to participate in the trial. Each will have an identifiable carer with a minimum of 3.5 hours of face to face contact each week.
Participants will undergo an assessment at baseline with retests at 6 and 12 months. Participants allocated to the intervention group will participate in an exercise and home hazard reduction program tailored to their cognitive and physical abilities.
The primary outcome measure will be the rate of falls which will be measured using monthly falls calendars. Secondary outcome measures will include the risk of falling, quality of life, measures of physical and cognitive function, fear of falling and planned and unplanned use of health services. Carers will be followed up to determine carer burden, coping strategies and quality of life.
Discussion
The study will determine the impact of this tailored intervention in reducing the rate of falls in community dwelling older people with CI as well as the cost-effectiveness and adherence to the program. The results will have direct implications for the design and implementation of interventions for this high-risk group of older people.
Trial registration
The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry - ACTRN12614000603617
doi:10.1186/1471-2318-14-89
PMCID: PMC4138412  PMID: 25128411
Cognitive impairment; Dementia; Accidental falls; Prevention; Intervention
19.  Effectiveness of a multifaceted podiatry intervention to prevent falls in community dwelling older people with disabling foot pain: randomised controlled trial 
Objective To determine the effectiveness of a multifaceted podiatry intervention in preventing falls in community dwelling older people with disabling foot pain.
Design Parallel group randomised controlled trial.
Setting University health sciences clinic in Melbourne, Australia.
Participants 305 community dwelling men and women (mean age 74 (SD 6) years) with disabling foot pain and an increased risk of falling. 153 were allocated to a multifaceted podiatry intervention and 152 to routine podiatry care, with 12 months’ follow-up.
Interventions Multifaceted podiatry intervention consisting of foot orthoses, advice on footwear, subsidy for footwear ($A100 voucher; £65; €74), a home based programme of foot and ankle exercises, a falls prevention education booklet, and routine podiatry care for 12 months. The control group received routine podiatry care for 12 months.
Main outcome measures Proportion of fallers and multiple fallers, falling rate, and injuries resulting from falls during follow-up.
Results Overall, 264 falls occurred during the study. 296 participants returned all 12 calendars: 147 (96%) in the intervention group and 149 (98%) in the control group. Adherence was good, with 52% of the participants completing 75% or more of the requested three exercise sessions weekly, and 55% of those issued orthoses reporting wearing them most of the time. Participants in the intervention group (n=153) experienced 36% fewer falls than participants in the control group (incidence rate ratio 0.64, 95% confidence interval 0.45 to 0.91, P=0.01). The proportion of fallers and multiple fallers did not differ significantly between the groups (relative risk 0.85, 0.66 to 1.08, P=0.19 and 0.63, 0.38 to 1.04, P=0.07). One fracture occurred in the intervention group and seven in the control group (0.14, 0.02 to 1.15, P=0.07). Significant improvements in the intervention group compared with the control group were found for the domains of strength (ankle eversion), range of motion (ankle dorsiflexion and inversion/eversion), and balance (postural sway on the floor when barefoot and maximum balance range wearing shoes).
Conclusions A multifaceted podiatry intervention reduced the rate of falls in community dwelling older people with disabling foot pain. The components of the intervention are inexpensive and relatively simple to implement, suggesting that the programme could be incorporated into routine podiatry practice or multidisciplinary falls prevention clinics.
Trial registration Australian New Zealand Clinical Trials Registry ACTRN12608000065392.
doi:10.1136/bmj.d3411
PMCID: PMC3116775  PMID: 21680622
20.  Does progressive resistance and balance exercise reduce falls in residential aged care? Randomized controlled trial protocol for the SUNBEAM program 
Introduction
Falls are common among older adults. It is reported that approximately 60% of residents of aged care facilities fall each year. This is a major cause of morbidity and mortality, and a significant burden for health care providers and the health system. Among community dwelling older adults, exercise appears to be an effective countermeasure, but data are limited and inconsistent among studies in residents of aged care communities. This trial has been designed to evaluate whether the SUNBEAM program (Strength and Balance Exercise in Aged Care) reduces falls in residents of aged care facilities.
Research question
Is the program more effective and cost-effective than usual care for the prevention of falls?
Design
Single-blinded, two group, cluster randomized trial.
Participants and setting
300 residents, living in 20 aged care facilities.
Intervention
Progressive resistance and balance training under the guidance of a physiotherapist for 6 months, then facility-guided maintenance training for 6 months.
Control
Usual care.
Measurements
Number of falls, number of fallers, quality of life, mobility, balance, fear of falling, cognitive well-being, resource use, and cost-effectiveness. Measurements will be taken at baseline, 6 months, and 12 months.
Analysis
The number of falls will be analyzed using a Poisson mixed model. A logistic mixed model will be used to analyze the number of residents who fall during the study period. Intention-to-treat analysis will be used.
Discussion
This study addresses a significant shortcoming in aged care research, and has potential to impact upon a substantial health care problem. Outcomes will be used to inform care providers, and guide health care policies.
doi:10.2147/CIA.S53931
PMCID: PMC3937111  PMID: 24591821
balance; strength; training; falls; nursing care; cost-effectiveness
21.  Minimising disability and falls in older people through a post-hospital exercise program: a protocol for a randomised controlled trial and economic evaluation 
BMC Geriatrics  2009;9:8.
Background
Disability and falls are particularly common among older people who have recently been hospitalised. There is evidence that disability severity and fall rates can be reduced by well-designed exercise interventions. However, the potential for exercise to have these benefits in older people who have spent time in hospital has not been established.
This randomised controlled trial will investigate the effects of a home-based exercise program on disability and falls among people who have had recent hospital stays. The cost-effectiveness of the exercise program from the health and community service provider's perspective will be established. In addition, predictors for adherence with the exercise program will be determined.
Methods and design
Three hundred and fifty older people who have recently had hospital stays will participate in the study. Participants will have no medical contraindications to exercise and will be cognitively and physically able to complete the assessments and exercise program.
The primary outcome measures will be mobility-related disability (measured with 12 monthly questionnaires and the Short Physical Performance Battery) and falls (measured with 12 monthly calendars). Secondary measures will be tests of risk of falling, additional measures of mobility, strength and flexibility, quality of life, fall-related self efficacy, health-system and community-service contact, assistance from others, difficulty with daily tasks, physical activity levels and adverse events.
After discharge from hospital and completion of all hospital-related treatments, participants will be randomly allocated to an intervention group or usual-care control group. For the intervention group, an individualised home exercise program will be established and progressed during ten home visits from a physiotherapist. Participants will be asked to exercise at home up to 6 times per week for the 12-month study period.
Discussion
The study will determine the impact of this exercise intervention on mobility-related disability and falls in older people who have been in hospital as well as cost-effectiveness and predictors of adherence to the program. Thus, the results will have direct implications for the design and implementation of interventions for this high-risk group of older people.
Trial Registration
The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12607000563460.
doi:10.1186/1471-2318-9-8
PMCID: PMC2660334  PMID: 19245697
22.  The effect of Tai Chi Chuan in reducing falls among elderly people: design of a randomized clinical trial in the Netherlands [ISRCTN98840266] 
BMC Geriatrics  2006;6:6.
Background
Falls are a significant public health problem. Thirty to fifty percent of the elderly of 65 years and older fall each year. Falls are the most common type of accident in this age group and can result in fractures and subsequent disabilities, increased fear of falling, social isolation, decreased mobility, and even an increased mortality. Several forms of exercise have been associated with a reduced risk of falling and with a wide range of physiological as well as psychosocial health benefits. Tai Chi Chuan seems to be the most promising form of exercise in the elderly, but the evidence is still controversial.
In this article the design of a randomized clinical trial is presented. The trial evaluates the effect of Tai Chi Chuan on fall prevention and physical and psychological function in older adults.
Methods/Design
270 people of seventy years and older living at home will be identified in the files of the participating general practitioners. People will be asked to participate when meeting the following inclusion criteria: have experienced a fall in the preceding year or suffer from two of the following risk factors: disturbed balance, mobility problems, dizziness, or the use of benzodiazepines or diuretics. People will be randomly allocated to either the Tai Chi Chuan group (13 weeks, twice a week) or the no treatment control group.
The primary outcome measure is the number of new falls, measured with a diary. The secondary outcome measures are balance, fear of falling, blood pressure, heart rate, lung function parameters, physical activity, functional status, quality of life, mental health, use of walking devices, medication, use of health care services, adjustments to the house, severity of fall incidents and subsequent injuries. Process parameters will be measured to evaluate the Tai Chi Chuan intervention. A cost-effectiveness analysis will be carried out alongside the evaluation of the clinical results. Follow-up measurements will be collected at 3, 6 and 12 months after randomization.
Discussion
As far as we know this is the first trial in Europe considering Tai Chi Chuan and fall prevention. This project will answer a pragmatic research question regarding the efficacy of Tai Chi Chuan regarding fall reduction.
doi:10.1186/1471-2318-6-6
PMCID: PMC1513573  PMID: 16573825
23.  Effectiveness of balance training exercise in people with mild to moderate severity Alzheimer's disease: protocol for a randomised trial 
BMC Geriatrics  2009;9:29.
Background
Balance dysfunction and falls are common problems in later stages of dementia. Exercise is a well-established intervention to reduce falls in cognitively intact older people, although there is limited randomised trial evidence of outcomes in people with dementia. The primary objective of this study is to evaluate whether a home-based balance exercise programme improves balance performance in people with mild to moderate severity Alzheimer's disease.
Methods/design
Two hundred and fourteen community dwelling participants with mild to moderate severity Alzheimer's disease will be recruited for the randomised controlled trial. A series of laboratory and clinical measures will be used to evaluate balance and mobility performance at baseline. Participants will then be randomized to receive either a balance training home exercise programme (intervention group) from a physiotherapist, or an education, information and support programme from an occupational therapist (control group). Both groups will have six home visits in the six months following baseline assessment, as well as phone support. All participants will be re-assessed at the completion of the programme (after six months), and again in a further six months to evaluate sustainability of outcomes. The primary outcome measures will be the Limits of Stability (a force platform measure of balance) and the Step Test (a clinical measure of balance). Secondary outcomes include other balance and mobility measures, number of falls and falls risk measures, cognitive and behavioural measures, and carer burden and quality of life measures. Assessors will be blind to group allocation.
Longitudinal change in balance performance will be evaluated in a sub-study, in which the first 64 participants of the control group with mild to moderate severity Alzheimer's disease, and 64 age and gender matched healthy participants will be re-assessed on all measures at initial assessment, and then at 6, 12, 18 and 24 months.
Discussion
By introducing a balance programme at an early stage of the dementia pathway, when participants are more likely capable of safe and active participation in balance training, there is potential that balance performance will be improved as dementia progresses, which may reduce the high falls risk at this later stage. If successful, this approach has the potential for widespread application through community based services for people with mild to moderate severity Alzheimer's disease.
Trial registration
The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12608000040369).
doi:10.1186/1471-2318-9-29
PMCID: PMC2722658  PMID: 19607686
24.  Osteo-cise: Strong Bones for Life: Protocol for a community-based randomised controlled trial of a multi-modal exercise and osteoporosis education program for older adults at risk of falls and fractures 
Background
Osteoporosis affects over 220 million people worldwide, and currently there is no ‘cure’ for the disease. Thus, there is a need to develop evidence-based, safe and acceptable prevention strategies at the population level that target multiple risk factors for fragility fractures to reduce the health and economic burden of the condition.
Methods/design
The Osteo-cise: Strong Bones for Life study will investigate the effectiveness and feasibility of a multi-component targeted exercise, osteoporosis education/awareness and behavioural change program for improving bone health and muscle function and reducing falls risk in community-dwelling older adults at an increased risk of fracture. Men and women aged ≥60 years will participate in an 18-month randomised controlled trial comprising a 12-month structured and supervised community-based program and a 6-month ‘research to practise’ translational phase. Participants will be randomly assigned to either the Osteo-cise intervention or a self-management control group. The intervention will comprise a multi-modal exercise program incorporating high velocity progressive resistance training, moderate impact weight-bearing exercise and high challenging balance exercises performed three times weekly at local community-based fitness centres. A behavioural change program will be used to enhance exercise adoption and adherence to the program. Community-based osteoporosis education seminars will be conducted to improve participant knowledge and understanding of the risk factors and preventative measures for osteoporosis, falls and fractures. The primary outcomes measures, to be collected at baseline, 6, 12, and 18 months, will include DXA-derived hip and spine bone mineral density measurements and functional muscle power (timed stair-climb test). Secondary outcomes measures include: MRI-assessed distal femur and proximal tibia trabecular bone micro-architecture, lower limb and back maximal muscle strength, balance and function (four square step test, functional reach test, timed up-and-go test and 30-second sit-to-stand), falls incidence and health-related quality of life. Cost-effectiveness will also be assessed.
Discussion
The findings from the Osteo-cise: Strong Bones for Life study will provide new information on the efficacy of a targeted multi-modal community-based exercise program incorporating high velocity resistance training, together with an osteoporosis education and behavioural change program for improving multiple risk factors for falls and fracture in older adults at risk of fragility fracture.
Trial registration
Australian New Zealand Clinical Trials Registry reference ACTRN12609000100291
doi:10.1186/1471-2474-13-78
PMCID: PMC3544181  PMID: 22640372
Osteoporosis; High velocity resistance training; Falls prevention; Bone mineral density; Muscle function; Community program
25.  Recurrent Falls in Parkinson's Disease: A Systematic Review 
Parkinson's Disease  2013;2013:906274.
Most people with Parkinson's disease (PD) fall and many experience recurrent falls. The aim of this review was to examine the scope of recurrent falls and to identify factors associated with recurrent fallers. A database search for journal articles which reported prospectively collected information concerning recurrent falls in people with PD identified 22 studies. In these studies, 60.5% (range 35 to 90%) of participants reported at least one fall, with 39% (range 18 to 65%) reporting recurrent falls. Recurrent fallers reported an average of 4.7 to 67.6 falls per person per year (overall average 20.8 falls). Factors associated with recurrent falls include: a positive fall history, increased disease severity and duration, increased motor impairment, treatment with dopamine agonists, increased levodopa dosage, cognitive impairment, fear of falling, freezing of gait, impaired mobility and reduced physical activity. The wide range in the frequency of recurrent falls experienced by people with PD suggests that it would be beneficial to classify recurrent fallers into sub-groups based on fall frequency. Given that there are several factors particularly associated with recurrent falls, fall management and prevention strategies specifically targeting recurrent fallers require urgent evaluation in order to inform clinical practice.
doi:10.1155/2013/906274
PMCID: PMC3606768  PMID: 23533953

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