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1.  Telephone-delivered psychotherapy for rural-dwelling older adults with generalized anxiety disorder: study protocol of a randomized controlled trial 
BMC Psychiatry  2014;14:34.
Background
Generalized Anxiety Disorder (GAD), characterized by excessive and uncontrollable worry, has a negative impact on the health, well-being, and functioning of older adults. Cognitive behavioral therapy has demonstrated efficacy in reducing anxiety and worry in older adults, but the generalizability of these findings to community-dwelling older adults is unknown. The aim of the current study is to examine the efficacy of a cognitive-behavioral intervention delivered by telephone in reducing anxiety and worry in rural community-dwelling older adults with GAD.
Methods/Design
We propose a randomized controlled trial comparing telephone-delivered cognitive behavioral therapy (CBT-T) with nondirective supportive therapy (NST-T). One hundred seventy six adults 60 years and older diagnosed with GAD will be randomized to one of the two treatment conditions. The primary outcomes are self-report worry and clinician-rated anxiety. Secondary outcomes include depressive symptoms, sleep, quality of life, and functional status.
Discussion
It is hypothesized that CBT-T will be superior to NST-T in reducing anxiety and worry among older adults with GAD. Further, CBT-T is hypothesized to be superior to NST-T in reducing problems with depressive symptoms, sleep, functional status and quality of life. If this program is successful, it could be implemented as a low-cost program to treat late-life anxiety, especially in rural areas or in circumstances where older adults may not have access to qualified mental health providers.
Trial registration
clinicaltrials.gov Identifier: NCT01259596
doi:10.1186/1471-244X-14-34
PMCID: PMC3926701  PMID: 24506950
Generalized anxiety disorder; Older adults; Randomized controlled trial; Rural mental health; Telephone-delivered psychotherapy
2.  Resistance exercise performance variability at submaximal intensities in older and younger adults 
We assessed the variability in the number of repetitions completed at submaximal loads in three resistance tasks in older (N=32, 16 female, 74.3±5.4 years) and younger (N=16, 8 female, 22.8±1.8 years) men and women. One repetition maximum (1RM) was determined on two separate visits on three tasks: leg press (LP), leg extension (LE), and bicep curl (BC). Subjects then completed repetitions to failure on each of the three tasks during two visits, a minimum of 48 hours apart, at either 60% 1RM or 80% 1RM. High reliability for all 1RM assessments was observed. Greater muscular strength was observed in younger compared to older men and women on all tasks (P<0.05). At both 60% and 80% 1RM, considerable interindividual variability was observed in the number of repetitions completed. However, the average number of repetitions completed by younger and older men and women at 60% and 80% 1RM in each of the three tasks was similar, with the only significant difference occurring between younger and older men at 80% 1RM on the leg press (P=0.0258). We did not observe any abnormal blood pressure responses to either the 1RM testing or maximal repetition testing sessions. Considerable interindividual variability was observed in the number of repetitions completed by younger and older men and women at relative intensities typical of resistance training programs. Practitioners should give consideration to individual variability when attempting to maximize the benefits of resistance training.
doi:10.2147/CIA.S55719
PMCID: PMC3900316  PMID: 24465127
resistance exercise; exercise prescription; relative intensity; reliability; older adults; blood pressure
3.  Fat Mass Loss Predicts Gain in Physical Function With Intentional Weight Loss in Older Adults 
Background.
Clinical recommendation of weight loss (WL) in older adults remains controversial, partially due to concerns regarding lean mass loss and potential loss of physical function. The purpose of this study is to determine the independent associations between changes in fat and lean mass and changes in physical function in older, overweight, and obese adults undergoing intentional WL.
Methods.
Data from three randomized-controlled trials of intentional WL in older adults with similar functional outcomes (short physical performance battery and Pepper assessment tool for disability) were combined. Analyses of covariance models were used to investigate relationships between changes in weight, fat, and lean mass (acquired using dual-energy x-ray absorptiometry) and changes in physical function.
Results.
Overall loss of body weight was −7.8 ± 6.1 kg (−5.6 ± 4.1 kg and −2.7 ± 2.4 kg of fat and lean mass, respectively). In all studies combined, after adjustment for age, sex, and height, overall WL was associated with significant improvements in self-reported mobility disability (p < .01) and walking speed (p < .01). Models including change in both fat and lean mass as independent variables found only the change in fat mass to significantly predict change in mobility disability (β[fat] = 0.04; p < .01) and walking speed (β[fat] = −0.01; p < .01).
Conclusions.
Results from this study demonstrate that loss of body weight, following intentional WL, is associated with significant improvement in self-reported mobility disability and walking speed in overweight and obese older adults. Importantly, fat mass loss was found to be a more significant predictor of change in physical function than lean mass loss.
doi:10.1093/gerona/gls092
PMCID: PMC3598365  PMID: 22503993
Physical function; Weight loss; Fat mass; Lean mass; Aging
4.  Promoting physical activity for elders with compromised function: the lifestyle Interventions and Independence for elders (LIFE) study physical activity intervention 
The Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase III randomized controlled clinical trial (Clinicaltrials.gov identifier: NCT01072500) that will provide definitive evidence regarding the effect of physical activity (PA) on major mobility disability in older adults (70–89 years old) who have compromised physical function. This paper describes the methods employed in the delivery of the LIFE Study PA intervention, providing insight into how we promoted adherence and monitored the fidelity of treatment. Data are presented on participants’ motives and self-perceptions at the onset of the trial along with accelerometry data on patterns of PA during exercise training. Prior to the onset of training, 31.4% of participants noted slight conflict with being able to meet the demands of the program and 6.4% indicated that the degree of conflict would be moderate. Accelerometry data collected during PA training revealed that the average intensity – 1,555 counts/minute for men and 1,237 counts/minute for women – was well below the cutoff point used to classify exercise as being of moderate intensity or higher for adults. Also, a sizable subgroup required one or more rest stops. These data illustrate that it is not feasible to have a single exercise prescription for older adults with compromised function. Moreover, the concept of what constitutes “moderate” exercise or an appropriate volume of work is dictated by the physical capacities of each individual and the level of comfort/stability in actually executing a specific prescription.
doi:10.2147/CIA.S49737
PMCID: PMC3775623  PMID: 24049442
aging; accelerometry; physical disability; compromised physical function; older adults
5.  A Randomized Controlled Trial of Telephone-Delivered Cognitive-Behavioral Therapy for Late-life Anxiety Disorders 
Objectives
Older adults face a number of barriers to receiving psychotherapy, such as a lack of transportation and access to providers. One way to overcome such barriers is to provide treatment by telephone. The purpose of this study was to examine the effects of cognitive behavioral therapy delivered by telephone (CBT-T) to older adults diagnosed with an anxiety disorder.
Design
Randomized controlled trial.
Setting
Participants' homes.
Participants
Sixty participants ≥ 60 years of age with a diagnosis of Generalized Anxiety Disorder, Panic Disorder, or Anxiety Disorder Not Otherwise Specified.
Intervention
CBT-T vs. information-only comparison.
Measurements
Co-primary outcomes included worry (Penn State Worry Questionnaire) and general anxiety (State Trait Anxiety Inventory). Secondary outcomes included clinician-rated anxiety (Hamilton Anxiety Rating Scale), anxiety sensitivity (Anxiety Sensitivity Index), depressive symptoms (Beck Depression Inventory), quality of life (SF-36), and sleep (Insomnia Severity Index). Assessments were completed prior to randomization, immediately upon completion of treatment, and 6 months after completing treatment.
Results
CBT-T was superior to information-only in reducing general anxiety (ES = 0.71), worry (ES = 0.61), anxiety sensitivity (ES = 0.85), and insomnia (ES = 0.82) at the post-treatment assessment; however, only the reductions in worry were maintained by the 6 month follow-up assessment (ES = 0.80).
Conclusions
These results suggest that CBT-T may be efficacious in reducing anxiety and worry in older adults, but additional sessions may be needed to maintain these effects.
doi:10.1097/JGP.0b013e31822ccd3e
PMCID: PMC3407971  PMID: 22828172
anxiety; cognitive-behavioral therapy; elderly; Generalized Anxiety Disorder; Panic Disorder; telephone-delivered psychotherapy
6.  A nonviral pHEMA+chitosan nanosphere-mediated high-efficiency gene delivery system 
The transport of DNA into eukaryotic cells is minimal because of the cell membrane barrier, and this limits the application of DNA vaccines, gene silencing, and gene therapy. Several available transfection reagents and techniques have been used to circumvent this problem. Alternatively, nonviral nanoscale vectors have been shown to bypass the eukaryotic cell membrane. In the present work, we developed a unique nanomaterial, pHEMA+chitosan nanospheres (PCNSs), which consisted of poly(2-hydroxyethyl methacrylate) nanospheres surrounded by a chitosan cationic shell, and we used this for encapsulation of a respiratory syncytial virus (RSV)-F gene construct (a model for a DNA vaccine). The new nanomaterial was capable of transfecting various eukaryotic cell lines without the use of a commercial transfection reagent. Using transmission electron microscopy, (TEM), fluorescence activated cell sorting (FACS), and immunofluorescence, we clearly demonstrated that the positively charged PCNSs were able to bind to the negatively charged cell membrane and were taken up by endocytosis, in Cos-7 cells. Using quantitative polymerase chain reaction (qPCR), we also evaluated the efficiency of transfection achieved with PCNSs and without the use of a liposomal-based transfection mediator, in Cos-7, HEp-2, and Vero cells. To assess the transfection efficiency of the PCNSs in vivo, these novel nanomaterials containing RSV-F gene were injected intramuscularly into BALB/c mice, resulting in high copy number of the transgene. In this study, we report, for the first time, the application of the PCNSs as a nanovehicle for gene delivery in vitro and in vivo.
doi:10.2147/IJN.S43168
PMCID: PMC3629879  PMID: 23610520
pHEMA+chitosan nanoparticles; nonviral vector; RSV-DNA vaccine
7.  Poor Cognitive Function and Risk of Severe Hypoglycemia in Type 2 Diabetes 
Diabetes Care  2012;35(4):787-793.
OBJECTIVE
Self-management of type 2 diabetes including avoidance of hypoglycemia is complex, but the impact of cognition on safe self-management is not well understood. This study aimed to assess the effect of baseline cognitive function and cognitive decline on subsequent risk of severe hypoglycemia and to assess the effect of different glycemic strategies on these relationships.
RESEARCH DESIGN AND METHODS
Prospective cohort analysis of data from the ACCORD trial included 2,956 adults aged ≥55 years with type 2 diabetes and additional cardiovascular risk factors. Cognitive tests (Digit Symbol Substitution Test [DSST], Rey Auditory Verbal Learning Test, Stroop Test, and Mini Mental Status Examination) were conducted at baseline and 20 months. Study outcomes were incident confirmed severe hypoglycemia requiring medical assistance (HMA) and hypoglycemia requiring any assistance (HAA).
RESULTS
After a median 3.25-year follow-up, a 5-point-poorer baseline score on the DSST was predictive of a first episode of HMA (hazard ratio 1.13 [95% CI 1.08–1.18]). Analyses of the other cognitive tests and of HAA were consistent with the DSST results. Cognitive decline over 20 months increased the risk of subsequent hypoglycemia to a greater extent in those with lower baseline cognitive function (Pinteraction = 0.037). Randomization to an intensive versus standard glycemic strategy had no impact on the relationship between cognitive function and the risk of severe hypoglycemia.
CONCLUSIONS
Poor cognitive function increases the risk of severe hypoglycemia in patients with type 2 diabetes. Clinicians should consider cognitive function in assessing and guiding their patients regarding safe diabetes self-management regardless of their glycemic targets.
doi:10.2337/dc11-1855
PMCID: PMC3308284  PMID: 22374637
8.  The Impact of Frequent and Unrecognized Hypoglycemia on Mortality in the ACCORD Study 
Diabetes Care  2012;35(2):409-414.
OBJECTIVE
The aim of this study was to examine the relationship between frequent and unrecognized hypoglycemia and mortality in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study cohort.
RESEARCH DESIGN AND METHODS
A total of 10,096 ACCORD study participants with follow-up for both hypoglycemia and mortality were included. Hazard ratios (95% CIs) relating the risk of death to the updated annualized number of hypoglycemic episodes and the updated annualized number of intervals with unrecognized hypoglycemia were obtained using Cox proportional hazards regression models, allowing for these hypoglycemia variables as time-dependent covariates and controlling for the baseline covariates.
RESULTS
Participants in the intensive group reported a mean of 1.06 hypoglycemic episodes (self-monitored blood glucose <70 mg/dL or <3.9 mmol/L) in the 7 days preceding their regular 4-month visit, whereas participants in the standard group reported an average of 0.29 episodes. Unrecognized hypoglycemia was reported, on average, at 5.8% of the intensive group 4-month visits and 2.6% of the standard group visits. Hazard ratios for mortality in models including frequency of hypoglycemic episodes were 0.93 (95% CI 0.9–0.97; P < 0.001) for participants in the intensive group and 0.98 (0.91–1.06; P = 0.615) for participants in the standard group. The hazard ratios for mortality in models, including unrecognized hypoglycemia, were not statistically significant for either group.
CONCLUSIONS
Recognized and unrecognized hypoglycemia was more common in the intensive group than in the standard group. In the intensive group of the ACCORD study, a small but statistically significant inverse relationship of uncertain clinical importance was identified between the number of hypoglycemic episodes and the risk of death among participants.
doi:10.2337/dc11-0996
PMCID: PMC3263892  PMID: 22179956
9.  Characterizing upper limb muscle volume and strength in older adults: A comparison with young adults 
Journal of biomechanics  2011;45(2):334-341.
Aging is associated with loss of muscle volume (MV) and force leading to difficulties with activities of daily living. However, the relationship between upper limb MV and joint strength has not been characterized for older adults. Quantifying this relationship may help our understanding of the functional upper limb declines older adults experience. Our objective was to assess the relationship between upper limb MV and maximal isometric joint moment-generating capacity (IJM) in a single cohort of healthy older adults (age≥65 years) for 6 major functional groups (32 muscles). MV was determined from MRI for 18 participants (75.1±4.3 years). IJM at the shoulder (abduction/adduction), elbow (flexion/extension), and wrist (flexion/extension) was measured. MV and IJM measurements were compared to previous reports for young adults (28.6±4.5 years). On average older adults had 16.5% less total upper limb MV compared to young adults. Additionally, older adult wrist extensors composed a significantly increased percentage of upper limb MV. Older adult IJM was reduced across all joints, with significant differences for shoulder abductors (p<0.0001), adductors (p=0.01), and wrist flexors (p<0.0001). Young adults were strongest at the shoulder, which was not the case for older adults. In older adults, 40.6% of the variation in IJM was accounted for by MV changes (p≤0.027), compared to 81.0% in young adults. We conclude that for older adults, MV and IJM are, on average, reduced but the significant linear relationship between MV and IJM is maintained. These results suggest that older adult MV and IJM cannot be simply scaled from young adults.
doi:10.1016/j.jbiomech.2011.10.007
PMCID: PMC3246044  PMID: 22047782
Muscle volume; Strength; Upper limb; Aging; Joint moment
10.  Muscle Strength and BMI as Predictors of Major Mobility Disability in the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) 
Background.
Muscle weakness and obesity are two significant threats to mobility facing the increasing number of older adults. To date, there are no studies that have examined the association of strength and body mass index (BMI) on event rates on a widely used performance measure of major mobility disability.
Methods.
This study was a secondary analysis of a randomized controlled trial in which sedentary functionally limited participants (70–89 years, Short Physical Performance Battery ≤ 9) who were able to complete a 400-m walk test at baseline were randomized to a physical activity or health education intervention and reassessed for major mobility disability every 6 months for up to 18 months. We evaluated whether baseline grip strength and BMI predicted failure to complete the 400-m walk test in 15 minutes or less (major mobility disability).
Results.
Among N = 406 participants with baseline measures, lower grip strength was associated with an increased risk for developing major mobility disability, with and without covariate adjustment (p < .01): The hazard ratio (95% confidence interval) for the lowest versus high sex-specific quartile of grip strength was 6.11 (2.24–16.66). We observed a U-shaped relationship between baseline BMI and the risk of developing major mobility disability, such that the risk for participants with a BMI of 25–29 kg/m2 was approximately half that of participants with BMI less than 25 or 30 kg/m2 or more (p = .04 in fully adjusted analyses).
Conclusions.
Our data highlight the importance of muscle weakness, low BMI, and obesity as risk factors for major mobility disability in older adults. Being overweight may be protective for major mobility disability.
doi:10.1093/gerona/glr158
PMCID: PMC3210962  PMID: 21975090
Physical disability; Physical activity; Older adults
11.  Effects of randomization to intensive glucose lowering on brain structure and function in type 2 diabetes ACCORD Memory in Diabetes Study 
Lancet Neurology  2011;10(11):969-977.
Background
Persons with type 2 diabetes (T2D) are at risk for cognitive impairment and brain atrophy. The ACCORD Memory in Diabetes (MIND) Study investigated whether persons randomized to an intensive glycaemic therapeutic strategy targeting HbA1c to <6% had better cognitive function and a larger brain volume at 40 months than persons randomized to a standard strategy targeting HbA1c to 7%–7.9%.
Methods
ACCORD MIND was a double 2×2 factorial parallel group randomised trial conducted in 52 clinical sites in North America. Participants [age 55 – <80 years] with T2D, high HbA1c concentrations (>7.5%), and at high risk for cardiovascular events were randomised to treatment groups using a centralized web-based system. Clinic staff and participants were not blinded to treatment arm. The cognitive primary outcome, the Digit Symbol Substitution Test (DSST) score, was assessed at baseline, 20 and 40 months. Total brain volume (TBV), the primary brain structure outcome, was assessed with MRI at baseline and 40 months in a sub-set of 632 participants. All participants with follow-up data were included in the primary analyses. In February, 2008, increased mortality risk led to the termination of the intensive therapy and transition of those participants to standard glycaemic treatment.
Results
Randomised patients (n=2977; mean age 62.3 years) were consecutively enrolled; the final analysis included 1358 intensive and 1416 standard arm participants with a 20 or 40 month DSST score. Of the 614 with a baseline MRI, 230 intensive and 273 standard therapy participants were included in the analysis. There was no treatment difference in the DSST score. The intensive group had a greater TBV than the standard group (difference, 4.62; 95% CI 2.0 to7.3 cm3; p=0.0007).
Interpretation
Although significant differences in TBV favored the intensive therapy, cognitive outcomes were not different. Combined with the unfavorable effects on other ACCORD outcomes, MIND findings do not support using intensive therapy to reduce the adverse effects of diabetes on the brain in patients similar to MIND participants. (ClinicalTrials.gov number, NCT00182910).
doi:10.1016/S1474-4422(11)70188-0
PMCID: PMC3333485  PMID: 21958949
12.  Cognitive Function and Fine Motor Speed in Older Women with Diabetes Mellitus: Results from the Women's Health Initiative Study of Cognitive Aging 
Journal of Women's Health  2011;20(10):1435-1443.
Abstract
Background
We sought to determine if type 2 diabetes mellitus (T2DM) was associated with accelerated decline in domain-specific measures of cognitive function and fine motor speed.
Methods
Women aged 65–80 years who were enrolled in a clinical trial of postmenopausal hormone therapy were grouped as having T2DM (n=179) or not (n=1984) and followed for an average of 5 years with annual standardized assessments of domain-specific cognitive function. Mean patterns of cognitive measures over time were contrasted between groups using general linear models and Wald tests, with varying levels of covariate adjustment. The influences of age at onset, use of oral medications, and use of insulin were also examined.
Results
T2DM was associated with mean deficits of 0.2–0.4 standard deviations (SD) across follow-up in most cognitive domains. Consistent evidence that rates of decline were accelerated among women with T2DM was evident only for verbal knowledge and verbal memory (p<0.05). Decrements in fine motor speed, but no measure of cognitive function, were greater for women with earlier onset T2DM. Use of oral diabetes medications was associated with better relative cognitive function.
Conclusions
In these women, T2DM was associated with cognitive deficits in most domains. Relative deficits in verbal knowledge and verbal memory may continue to increase after deficits in other domains have stabilized. Relative deficits in fine motor speed may be greater among women with earlier onsets of T2DM. Use of insulin, which may reflect greater T2DM severity, was associated with relatively greater cognitive deficits.
doi:10.1089/jwh.2011.2812
PMCID: PMC3186442  PMID: 21819251
13.  Biomarkers of Renal Function and Cognitive Impairment in Patients With Diabetes 
Diabetes Care  2011;34(8):1827-1832.
OBJECTIVE
Kidney disease is associated with cognitive impairment in studies of nondiabetic adults. We examined the cross-sectional relation between three measures of renal function and performance on four measures of cognitive function in the Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes (ACCORD-MIND) study.
RESEARCH DESIGN AND METHODS
The relationships among estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (n = 2,968), albumin/creatinine ratio (ACR) ≥30 μg/mg (n = 2,957), and cystatin C level >1.0 mg/L (n = 532) with tertile of performance on the Mini-Mental State Examination, Rey Auditory Verbal Learning Test (RAVLT), Digit Symbol Substitution Test (DSST), and Stroop Test of executive function were measured.
RESULTS
In adjusted logistic regression models, ACR ≥30 μg/mg was associated with performance in the lowest tertile, compared with the highest two tertiles, on the RAVLT (odds ratio 1.30, 95% CI 1.09–1.56, P = 0.006), equivalent to 3.6 years of aging, and on the DSST (1.47, 1.20–1.80, P = 0.001), equivalent to 3.7 years of aging. Cystatin C >1.0 mg/L was borderline associated with the lowest tertile on the DSST (1.81, 0.93–3.55, P = 0.08) and Stroop (1.78, 0.97–3.23, P = 0.06) in adjusted models. eGFR was not associated with any measure of cognitive performance.
CONCLUSIONS
In diabetic people with HbA1c >7.5% at high risk for cardiovascular disease, decreased cognitive function was associated with kidney disease as measured by ACR, a measure of microvascular endothelial pathology, and cystatin C, a marker of eGFR.
doi:10.2337/dc11-0186
PMCID: PMC3142061  PMID: 21715519
14.  Severe hypoglycemia symptoms, antecedent behaviors, immediate consequences and association with glycemia medication usage: Secondary analysis of the ACCORD clinical trial data 
Background
Hypoglycemia is a common complication of diabetes treatment. This paper describes symptoms, predecessors, consequences and medications associated with the first episode of severe hypoglycemia among ACCORD participants with type 2 diabetes, and compares these between intensive (Int: goal A1C <6.0%) and standard (Std, goal A1C 7–7.9%) glycemia intervention groups.
Methods
Information about symptoms, antecedents, and consequences was collected at the time participants reported an episode of severe hypoglycemia. Data on medications prescribed during the clinical trial was used to determine the association of particular diabetes drug classes and severe hypoglycemia.
Results
The most frequently reported symptoms in both glycemia group were weakness/fatigue (Int 29%; Std 30%) and sweating (Int 26%; Std 27%), followed by confusion/disorientation (Int 22%; Std 29%) and shakiness (Int 21%; Std 19%). Approximately half of all events were preceded by a variation in food intake (Int 48%; Std 58%). The most common consequences were confusion (Int 37%; Std 34%), loss of consciousness (Int 25%; Std 25%), and hospitalization (Int 18%; Std 24%). The highest rates of hypoglycemia were found among those participants treated with insulin only (Int 6.09/100 person yrs; Std 2.64/100 person yrs) while the lowest were among those prescribed oral agents only (Int 1.93/100 person yrs; Std 0.20/100 person yrs).
Conclusions
Severe hypoglycemia episodes were frequently preceded by a change in food intake, making many episodes potentially preventable. Symptoms of confusion/disorientation and loss of consciousness were frequently seen. The highest rates of hypoglycemia were seen with prescription of insulin, either alone or in combination with other medications.
Clinical Trial Registration
Number: NCT00000620
doi:10.1186/1472-6823-12-5
PMCID: PMC3433360  PMID: 22646230
Hypoglycemia; Type 2 diabetes
15.  Change in 25-Hydroxyvitamin D and Physical Performance in Older Adults 
Background.
Vitamin D deficiency is common among older adults and is associated with poor physical performance; however, studies examining longitudinal changes in 25-hydroxyvitamin D (25[OH]D) and physical performance are lacking. We examined the association between 25(OH)D and physical performance over 12 months in older adults participating in the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P), a multicenter physical activity intervention trial.
Methods.
Plasma 25(OH)D and physical performance, assessed by the short physical performance battery (SPPB) and 400-m walk test, were measured at baseline, 6-month, and 12-month follow-up in community-dwelling adults aged 70–89 years at risk for disability (n = 368). Mixed models were used to examine the association between 25(OH)D and physical performance adjusting for demographics, intervention group, season, body mass index, and physical activity.
Results.
One half of the participants were vitamin D deficient (25[OH]D < 20 ng/mL) at baseline. In cross-sectional analyses, vitamin D deficiency was associated with lower SPPB scores and slower 400-m walk speeds (mean difference [SE]: 0.35 [0.16], p = .03 and 0.04 [0.02] m/s, p = .01, respectively). Although baseline 25(OH)D status was not significantly associated with change in physical performance over 12 months, individuals who were vitamin D deficient at baseline but no longer deficient at follow-up had significant improvements in SPPB scores (mean difference [SE]: 0.55 [0.22], p = .01) compared with those whose 25(OH)D status remained the same.
Conclusion.
Increases in 25(OH)D to greater than or equal to 20 ng/mL were associated with clinically significant improvements in physical performance among older adults.
doi:10.1093/gerona/glq235
PMCID: PMC3055282  PMID: 21325343
Vitamin D; Physical performance; Aging
16.  The Effect of Pioglitazone and Resistance Training on Body Composition in Older Men and Women Undergoing Hypocaloric Weight Loss 
Obesity (Silver Spring, Md.)  2011;19(8):1636-1646.
Age-related increases in ectopic fat accumulation are associated with greater risk for metabolic and cardiovascular diseases, and physical disability. Reducing skeletal muscle fat and preserving lean tissue are associated with improved physical function in older adults. PPARγ-agonist treatment decreases abdominal visceral adipose tissue (VAT) and resistance training preserves lean tissue, but their effect on ectopic fat depots in nondiabetic overweight adults is unclear. We examined the influence of pioglitazone and resistance training on body composition in older (65–79 years) nondiabetic overweight/obese men (n = 48, BMI = 32.3 ± 3.8 kg/m2) and women (n = 40, BMI = 33.3 ± 4.9 kg/m2) during weight loss. All participants underwent a 16-week hypocaloric weight-loss program and were randomized to receive pioglitazone (30 mg/day) or no pioglitazone with or without resistance training, following a 2 × 2 factorial design. Regional body composition was measured at baseline and follow-up using computed tomography (CT). Lean mass was measured using dual X-ray absorptiometry. Men lost 6.6% and women lost 6.5% of initial body mass. The percent of fat loss varied across individual compartments. Men who were given pioglitazone lost more visceral abdominal fat than men who were not given pioglitazone (−1,160 vs. −647 cm3, P = 0.007). Women who were given pioglitazone lost less thigh subcutaneous fat (−104 vs. −298 cm3, P = 0.002). Pioglitazone did not affect any other outcomes. Resistance training diminished thigh muscle loss in men and women (resistance training vs. no resistance training men: −43 vs. −88 cm3, P = 0.005; women: −34 vs. −59 cm3, P = 0.04). In overweight/obese older men undergoing weight loss, pioglitazone increased visceral fat loss and resistance training reduced skeletal muscle loss. Additional studies are needed to clarify the observed gender differences and evaluate how these changes in body composition influence functional status.
doi:10.1038/oby.2010.327
PMCID: PMC3091968  PMID: 21233810
17.  Interruption of Physical Activity Because of Illness in the Lifestyle Interventions and Independence for Elders Pilot Trial 
Objectives
To examine baseline characteristics and change in gait speed and Short Physical Performance Battery (SPPB) scores in participants medically suspended (MS) from a physical activity intervention (PA).
Design
Randomized controlled trial.
Setting
University and community centers.
Participants
Sedentary older adults (N = 213) randomized to PA in the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P).
Measurements
MS was defined as missing 3 consecutive PA sessions in adoption and transition phases or 2 wk in maintenance phase because of a health event.
Results
In all, 122 participants completed PA without MS (NMS subgroup), 48 participants underwent MS and resumed PA (SR subgroup), and 43 participants underwent MS and did not complete PA (SNR subgroup). At baseline, SNR walked slower (p = .03), took more prescribed medications (p = .02), and had lower SPPB scores than NMS and SR (p = .02). Changes from baseline to Month 12 SPPB scores were affected by suspension status, adjusted mean (SE) SPPB change: SNR 0.0957 (0.3184), SR 0.9413 (0.3063), NMS 1.0720 (0.1871); p = .03.
Conclusions
MS participants unable to return to complete the PA in a trial of mobility-limited sedentary older adults had slower walking speeds, lower SPPB scores, and a higher number of prescribed medications at baseline. Change in SPPB scores at 12 months was related to suspension status.
PMCID: PMC3191494  PMID: 20181994
aging; randomized trial; medical suspension; medical comorbidities
18.  Relationship Between Physical Functioning and Physical Activity in the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) 
OBJECTIVES
To determine if participation in usual moderate-intensity or more vigorous physical activity (MVPA) is associated with physical function performance and to identify socio-demographic, psychosocial and disease-related covariates that may also compromise physical function performance.
DESIGN
Cross-sectional analysis of baseline variables of randomized controlled intervention trial.
SETTING
Four separate academic research centers.
PARTICIPANTS
Four hundred twenty-four older adults aged 70–89 years at risk for mobility-disability (scoring <10 on the Short Physical Performance Battery, SPPB) and able to complete the 400 m walk test within 15 minutes.
MEASUREMENTS
Minutes of MVPA (dichotomized according to above or below 150 min•wk−1 of MVPA) assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire, SPPB score, 400 M walk test, gender, body mass index (BMI), depressive symptoms, age and number of medications.
RESULTS
The SPPB summary score was associated with minutes of MVPA (ρ = 0.16, P = 0.001). In multiple regression analyses, age, minutes of MVPA, number of medications and depressive symptoms were associated with performance on the composite SPPB (P < 0.05). There was an association between 400 m walk time and minutes of MVPA (ρ = −0.18; P = 0.0002). In multiple regression analyses, age, gender, minutes of MVPA, BMI and number of medications were associated with performance on the 400 m walk test (P < 0.05).
CONCLUSION
Minutes of MVPA, gender, BMI, depressive symptoms, age, and number of medications are associated with physical function performance and all should be taken into consideration in the prevention of mobility-disability.
doi:10.1111/j.1532-5415.2010.03008.x
PMCID: PMC2952066  PMID: 20738437
older adults; mobility-disability; physical function performance; older adults; mobility-disability; physical function performance
19.  The Lifestyle Interventions and Independence for Elders Study: Design and Methods 
Background.
As the number of older adults in the United States rises, maintaining functional independence among older Americans has emerged as a major clinical and public health priority. Older people who lose mobility are less likely to remain in the community; demonstrate higher rates of morbidity, mortality, and hospitalizations; and experience a poorer quality of life. Several studies have shown that regular physical activity improves functional limitations and intermediate functional outcomes, but definitive evidence showing that major mobility disability can be prevented is lacking. A Phase 3 randomized controlled trial is needed to fill this evidence gap.
Methods.
The Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase 3 multicenter randomized controlled trial designed to compare a supervised moderate-intensity physical activity program with a successful aging health education program in 1,600 sedentary older persons followed for an average of 2.7 years.
Results.
LIFE's primary outcome is major mobility disability, defined as the inability to walk 400 m. Secondary outcomes include cognitive function, serious fall injuries, persistent mobility disability, the combined outcome of major mobility disability or death, disability in activities of daily living, and cost-effectiveness.
Conclusions.
Results of this study are expected to have important public health implications for the large and growing population of older sedentary men and women.
doi:10.1093/gerona/glr123
PMCID: PMC3193523  PMID: 21825283
Disability; Physical activity; Exercise; Geriatrics; Physical function
20.  A Lifestyle Activity Intervention in Patients with Chronic Obstructive Pulmonary Disease 
Respiratory medicine  2010;104(6):829-839.
SUMMARY
Background
Chronic obstructive pulmonary disease (COPD) patients have lower levels of physical activity compared to age-matched controls, and they limit physical activities requiring normal exertion. Our purpose was to compare the effectiveness of a traditional exercise therapy (TET) program with a behavioral lifestyle activity program (LAP) in promoting physical activity.
Methods
Moderate physical activity (kcal/week) was assessed in 176 COPD patients using the Community Health Activities Model for Seniors questionnaire. Patients were randomized to either a three month TET program that meet thrice weekly or a LAP. The LAP was designed to teach behavioral skills that encouraged the daily accumulation of self-selected physical activities of at least moderate intensity. Interventionist contact was similar (36 hours) between the two groups. Patients were assessed at baseline and 3, 6 and 12 months.
Results
Compared to baseline values, self-reported moderate physical activity increased three months post-randomization with no significant difference (p = 0.99) found between the TET (2,501 ± 197 kcal/week) and the LAP (2,498 ± 211 kcal/week). At 6 and 12 months post-randomization, there were no significant differences (p = 0.37 and 0.69, respectively) in self-reported levels of moderate physical activity between the TET (2,210 ± 187 and 2,213 ± 218 kcal/week, respectively) and the LAP (2,456 ± 198 and 2,342 ± 232 kcal/week, respectively).
Conclusion
Although there was no difference between treatment groups, the TET and the LAP were both effective at in increasing moderate levels of physical activity at 3 months and maintaining moderate physical activity levels 12 months post-randomization.
doi:10.1016/j.rmed.2010.02.015
PMCID: PMC2875358  PMID: 20347286
Chronic obstructive pulmonary disease; Exercise; Physical activity; Behavioral intervention
21.  The Effect of Randomization to Weight Loss on Total Mortality in Older Overweight and Obese Adults: The ADAPT Study 
Background.
Although weight loss reduces risk for comorbid diseases, many observational studies suggest that weight loss is associated with increased mortality risk, leading to reluctance by clinicians to consider weight reduction as a strategy to maintain health and independence in older adults. However, whether the observed weight loss is intentional is difficult to determine and may not accurately represent the mortality risk associated with intentional weight reduction. Data from the Arthritis, Diet, and Activity Promotion Trial (ADAPT) were used to determine whether randomization to a weight reduction program was associated with total mortality in overweight/obese older adults.
Methods.
ADAPT (n = 318; mean age 69 ± 6 years, body mass index 34 ± 5 kg/m2, 72% female) assessed the influence of weight loss (achieved through dietary counseling and lifestyle modification) and/or exercise on function in overweight/obese older adults with knee osteoarthritis. ADAPT ended in December 1999. Participant vital was ascertained status through December 2006 using the National Death and Social Security Indexes.
Results.
The mortality rate for those randomized to the 18-month weight loss intervention (n = 159, mean weight loss = −4.8 kg, 15 deaths) was lower than that for those not randomized to the weight loss intervention (n = 159, mean weight loss = −1.4 kg, 30 deaths; hazard rate ratio = 0.5, 95% confidence interval 0.3–1.0). Results were not appreciably changed when analyses were stratified by age, gender, baseline weight status, or magnitude of weight loss.
Conclusions.
In older adults, intentional weight loss was not associated with increased total mortality and may reduce mortality risk. Observational studies of weight loss, especially when intentionality cannot be rigorously established, may be misleading with respect to the effect of weight loss on mortality.
doi:10.1093/gerona/glp217
PMCID: PMC3107029  PMID: 20080875
Intentional weight loss; Mortality; Aging; Obesity
22.  Lack of Association between Thiazolidinediones and Macular Edema in Type 2 Diabetes: The ACCORD Eye Study 
Archives of ophthalmology  2010;128(3):312-318.
Objective
To assess the cross-sectional association of thiazolidinediones (TZD) with diabetic macular edema (DME).
Methods
The cross-sectional association of DME and visual acuity with TZD was examined using baseline fundus photographs and visual acuity measurements from the Eye Substudy of the ACCORD Trial. Visual acuity was assessed in 9,690 participants in ACCORD, 3,473 of these participants had fundus photographs that were centrally read in a standardized fashion by masked graders to assess DME and retinopathy.
Results
Among the sub-sample, 695 (20.0%) had TZD use while 217 (6.2%) had DME. TZD use was not associated with DME in unadjusted (OR=1.01, 95% CI: (0.71, 1.44), P=0.95) and adjusted analyses (OR=0.97, (0.67, 1.40), P=0.86). Significant associations with DME were found for retinopathy severity (P<0.0001) and age (OR=0.97, (0.952, 0.997), P=0.0298) but not for HbA1c (P=0.06), duration of diabetes (P=0.65), gender (P=0.72), and race (P=0.20). TZD use was associated with slightly greater visual acuity (0.79 letters, (0.20, 1.38), P=0.0091) of uncertain clinical significance.
Conclusions
In a cross-sectional analysis of data from the largest study to date, no association was observed between TZD exposure and DME in patients with type 2 diabetes; however, we cannot exclude a modest protective or harmful association.
doi:10.1001/archophthalmol.2009.310
PMCID: PMC3010554  PMID: 20212201
Type 2 Diabetes; macular edema; visual acuity; thiazolidinediones; Avandia; Actos; retinopathy; visual acuity; rosiglitazone; pioglitazone
23.  Standing after Spinal Cord Injury with Four-contact Nerve-Cuff Electrodes for Quadriceps Stimulation 
This report describes the performance of a 16-channel implanted neuroprosthesis for standing and transfers after spinal cord injury including four-contact nerve-cuff electrodes stimulating the femoral nerve for knee extension. Responses of the nerve-cuffs were stable and standing times increased by 600% over time-matched values with a similar 8-channel neuroprosthesis utilizing muscle-based electrodes on vastus lateralis for knee extension.
doi:10.1109/TNSRE.2008.2003390
PMCID: PMC2936226  PMID: 18990650
24.  Changes in Cognitive Function in a Randomized Trial of Physical Activity: Results of the Lifestyle Interventions and Independence for Elders Pilot Study 
Background
Cognitive impairment is an important contributor to disability. Limited clinical trial evidence exists regarding the impact of physical exercise on cognitive function (CF). We report results of a pilot study to provide estimates of the relative impact of physical activity (PA) on 1-year changes in cognitive outcomes and to characterize relationships between changes in mobility disability and changes in cognition in older adults at increased risk for disability.
Methods
Sedentary persons (102) at increased risk for disability (aged 70–89 years) were randomized to moderate-intensity PA or health education. Participants were administered the Digit Symbol Substitution Test (DSST), Rey Auditory Verbal Learning Test (RAVLT), modified Stroop test, and Modified Mini-Mental State Examination at baseline and 1 year.
Results
Group differences were not significant but improvements in cognitive scores were associated with improvements in physical function. Specifically, the DSST significantly correlated with change in the Short Physical Performance Battery score (r = .38, p = .0002), in chair stand score (r = .26, p = .012), in balance score (r = .21, p = .046), and in 400-m gait speed (r = .15, p = .147). Change recall on the RAVLT and in the Stroop test was also positively correlated with changes in chair stand and balance, respectively.
Conclusions
These results provide further support for the benefits of exercise on CF in older adults. An adequately powered clinical trial of PA involving older adults at increased risk for cognitive disability is needed to expand the indications for prescribing exercise for prevention of decline in brain function.
doi:10.1093/gerona/glp014
PMCID: PMC2679423  PMID: 19244157
Exercise; Cognition; Aging; Prevention; LIFE study
25.  Insomnia in Older Adults with Generalized Anxiety Disorder 
Objectives
The purposes of this study are to determine the frequency and severity of insomnia symptoms and related complaints experienced by older adults with GAD and compare them with older adults without GAD; compare insomnia symptoms among older adults with GAD with and without comorbid depression; determine if there are age differences in insomnia severity among people with GAD; and determine if there are differences in insomnia severity between older adults with GAD and older adults diagnosed with insomnia.
Design
Cross-sectional.
Setting
Participants were recruited through primary care clinics, advertisements, and mass mailings.
Participants
110 older adults; 31 with GAD, 25 with GAD and depression, 33 worried well, and 21 with no psychiatric diagnosis.
Measurements
Psychiatric diagnosis, sleep disturbance, and health.
Results
Participants with GAD with and without comorbid depression reported significantly greater sleep disturbance severity than participants with no psychiatric diagnosis and the worried well. There were no differences in sleep disturbances between older adults with GAD only and older adults with comorbid GAD and depression. The severity of sleep disturbance reported by older participants with GAD was greater than reports by young and middle-aged participants with GAD, and comparable to reports by older adults with a diagnosis of insomnia.
Conclusions
Ninety percent of older adults with GAD report dissatisfaction with sleep and the majority report moderate to severe insomnia. These findings support the assessment of sleep disturbances within the context of late-life GAD.
PMCID: PMC2699110  PMID: 19472436
Anxiety; GAD; insomnia; sleep

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