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1.  Comparison of the efficacy and safety of two starting dosages of prednisolone in early active rheumatoid arthritis (CORRA): study protocol for a randomized controlled trial 
Trials  2014;15(1):344.
Although glucocorticoids are widely used in the treatment of patients with early rheumatoid arthritis, the best dosage of glucocorticoids with regards to efficacy and safety is not known.
The aim of the study ‘Comparison of the efficacy and safety of two starting dosages of prednisolone in early active rheumatoid arthritis’ (CORRA) is to compare two standard glucocorticoid starting dosages and the non-use of glucocorticoids in the treatment of patients with early active rheumatoid arthritis on the background of the established ‘anchor’ therapy with methotrexate.
CORRA is an investigator-initiated, randomized, multicenter, double-blind, placebo-controlled trial with two treatment arms, starting with 60 mg or 10 mg prednisolone per day, tapered down to 5 mg prednisolone within eight weeks, and one placebo arm, each arm comprising 150 patients. The duration of the intervention is 12 weeks. In parallel, all patients will be treated with methotrexate (usual dosage 15 mg/week). The primary efficacy endpoint is the progression of radiographic joint damage after one year compared to baseline. Important secondary endpoints are the percentage of patients in remission, patient global assessment of disease activity, and changes of functional capacity. Safety monitoring is performed.
The statistical analysis is performed in three hierarchical steps. The first step is an analysis of covariance (α = 0.05) to compare the group with the initial prednisolone dosage of 60 mg and the placebo group. In case of a statistically significant result, the comparison of the group starting with 10 mg prednisolone with the placebo group will be performed as a second step (α = 0.05). In case of superiority of the 10 mg prednisolone group versus the placebo group, the third step will be a non-inferiority test for the 10 mg prednisolone group versus the 60 mg prednisolone group (α = 0.025).
The CORRA trial will yield information concerning the optimal glucocorticoid dosage schedule in the treatment of patients with early rheumatoid arthritis.
Trial registration
This trial was registered on 19 November 2013 at Registration number: NCT02000336.
PMCID: PMC4247757  PMID: 25181946
Rheumatoid arthritis; Glucocorticoids; Bridging therapy; Safety; Radiographic joint damage; Osteoporosis
2.  Falls and EQ-5D rated quality of life in community-dwelling seniors with concurrent chronic diseases: a cross-sectional study 
Although recommended for use in studies investigating falls in the elderly, the European Quality of Life Group instrument, EQ-5D, has not been widely used to assess the impact of falls on quality of life. The aim of this study was to investigate the association of single and frequent falls with EQ-5D rated quality of life in a sample of German community-dwelling seniors in primary care suffering a variety of concurrent chronic diseases and conditions.
In a cross-sectional study, a sample of community-dwelling seniors aged ≥ 72 years was interviewed by means of a standardised telephone interview. According to the number of self-reported falls within twelve months prior to interview, participants were categorised into one of three fall categories: no fall vs. one fall vs. two or more falls within twelve months. EQ-5D values as well as other characteristics were compared across the fall categories. Adjustments for a variety of concurrent chronic diseases and conditions and further variables were made by using multiple linear regression analysis, with EQ-5D being the target variable.
In total, 1,792 participants (median age 77 years; 53% female) were analysed. The EQ-5D differed between fall categories. Participants reporting no fall had a mean EQ-5D score of 81.1 (standard deviation [s.d.]: 15.4, median: 78.3), while participants reporting one fall (n = 265; 14.8%) and participants with two or more falls (n = 117; 6.5%) had mean total scores of 77.0 (s.d.: 15.8, median: 78.3; mean difference to participants without a fall: -4.1, p < 0.05) and 72.1 (s.d.: 17.6, median: 72.5; mean difference: -9.0, p < 0.05), respectively. The mean difference between participants with one fall and participants with two or more falls was -4.9 (p < 0.05). Under adjustment for a variety of chronic diseases and conditions, the mean decrease in the total EQ-5D score was about -1.0 score point for one fall and about -2.5 points for two or more falls within twelve months. In quantity, this decrease is comparable to other chronic diseases adjusted for. Among the variables with the greatest negative association with EQ-5D ratings in multivariate analysis were depression and fear of falling.
The findings suggest that falls are negatively associated with EQ-5D rated quality of life independent of a variety of chronic diseases and conditions.
PMCID: PMC3895701  PMID: 24400663
Falls; Accidental falls; Fear of falling; Multiple chronic diseases; Quality of life; EQ-5D; Elderly; Cross-sectional study
3.  Reliability of accelerometric measurement of physical activity in older adults-the benefit of using the trimmed sum 
There is general consensus that physical activity is important for preserving functional capacities of older adults and positively influencing quality of life. While accelerometry is widely accepted and applied to assess physical activity in studies, several problems with this method remain (e.g., low retest reliability, measurement errors). The aim of this study was to test the intra-instrumental retest reliability of a wrist-worn accelerometer in a 3-day measurement of physical activity in older adults and to compare different estimators. A sample of 123 older adults (76.5 ± 5.1 years, 59 % female) wore a uniaxial accelerometer continuously for 1 week. The data were split into two repeated measurement values (week set) of 3 days each. The sum, the 80–99th quantiles and the 80–99th trimmed sums were built for each week set. Retest reliability was assessed for each estimator and graphically demonstrated by Bland–Altman plots. The intraclass correlation of the retest reliability ranged from 0.22 to 0.91. Retest reliability increases when a more robust estimator than the overall sum is used. Therefore, the trimmed sum can be recommended as a conservative estimate of the physical activity level of older adults.
PMCID: PMC3459084  PMID: 23144665
Aged; Reproducibility of results; Activities of daily living; Bias (epidemiology)
4.  Barriers to physical activity in older adults in Germany: a cross-sectional study 
Data on barriers to physical activity in older adults in Germany are scarce. The aim of this study was to analyse barriers to physical activity in a cohort of older adults, allowing comparisons between men and women, and age groups.
1,937 older adults with a median age of 77 (range 72-93) years (53.3% female) took part in the 7-year follow-up telephone interviews of the getABI cohort. Participants who stated that they did not get enough physical activity were surveyed with respect to barriers to physical activity. Barriers were analysed for all respondents, as well as by sex and age group for cases with complete data. Multivariate logistic regression analysis was performed to evaluate differences between sexes and age groups. The level of significance (alpha < 0.05) was adjusted for multiple testing according to Bonferroni (p < .004).
1,607 (83.0%) participants stated that they were sufficiently physically active. 286 participants rated their physical activity as insufficient and responded to questions on barriers to physical activity completely. The three most frequently cited barriers were poor health (57.7%), lack of company (43.0%), and lack of interest (36.7%). Lack of opportunities for sports or leisure activities (30.3% vs. 15.6%), and lack of transport (29.0% vs. 7.1%) were more frequently stated by female respondents than male respondents. These differences between men and women were significant (p = .003; p < .001) after adjustment for respondents' age. Analyses by age groups revealed that poor health was more frequently considered a barrier to physical activity by participants aged 80+ years compared to the younger age group (71.1% vs. 51.5%). This age-dependent difference was significant (p = .002) irrespective of the participants' sex.
The present study provides relevant data on barriers to physical activity in older adults. By revealing appreciable differences between men and women, and age groups, this study has implications for efforts to increase older adults' physical activity. Promotion and intervention strategies should consider the barriers and tailor measures to the specific needs of older adults in order to reduce their constraints to physical activity.
PMCID: PMC3225299  PMID: 22047024
aged; motor activity; exercise; barrier; determinant; chronic disease
5.  Physical activity patterns in older men and women in Germany: a cross-sectional study 
BMC Public Health  2011;11:559.
Data on physical activity in older adults in Germany is scarce. The aim of this study was to analyze physical activity patterns and to explore factors associated with physical activity in different domains, i.e. sporting activities (SA) and domestic activities (DA), in older men and women.
As part of the 7-year follow-up telephone interviews of the getABI cohort (community-dwelling older adults in Germany), the PRISCUS-PAQ was used to survey participants about their everyday physical activity patterns. Time per week (hh:mm) spent in SA and DA (heavy housework, gardening) was analyzed for men and women. Multivariate logistic regression analyses were performed in order to assess the odds of participating in SA and DA for at least 2.5 hours/week in association with sociodemographic factors, a broad range of physical health-related factors and interview date (season of the year).
A total of 1,610 primary health care patients (51.6% women) with a median age of 77 (range 72-93) years were included in the analyses. Men engaged in SA more often than women (01:45 vs. 01:10), whereas women did more DA per week than men (04:00 vs. 03:00).
Being interviewed in spring or summer was associated with increased performance of DA in both sexes. Participation in these activities was reduced in more highly educated men and women. Living alone increased the odds of sports participation in women, but not in men. Most physical health-related factors were only selectively associated with either SA or DA, in men or women, respectively. The need for a walking aid was the only factor that consistently lowered the odds of being active in both activity domains and sexes.
This exploratory study delivers reliable and relevant data on the participation in and correlates of sporting and domestic activities of community-dwelling older adults for whom there had previously been only limited information at a population level in Germany. Findings are discussed and implications for epidemiological research and health promotion practice are provided.
PMCID: PMC3154867  PMID: 21752288
Aged; gender; physical activity; housework; gardening; correlates; public health
6.  General practitioner advice on physical activity: Analyses in a cohort of older primary health care patients (getABI) 
BMC Family Practice  2011;12:26.
Although the benefits of physical activity for health and functioning are recognized to extend throughout life, the physical activity level of most older people is insufficient with respect to current guidelines. The primary health care setting may offer an opportunity to influence and to support older people to become physically active on a regular basis. Currently, there is a lack of data concerning general practitioner (GP) advice on physical activity in Germany. Therefore, the aim of this study was to evaluate the rate and characteristics of older patients receiving advice on physical activity from their GP.
This is a cross-sectional study using data collected at 7 years of follow-up of a prospective cohort study (German epidemiological trial on ankle brachial index, getABI). 6,880 unselected patients aged 65 years and above in the primary health care setting in Germany were followed up since October 2001. During the 7-year follow-up telephone interview, 1,937 patients were asked whether their GP had advised them to get regular physical activity within the preceding 12 months. The interview also included questions on socio-demographic and lifestyle variables, medical conditions, and physical activity. Logistic regression analysis (unadjusted and adjusted for all covariables) was used to examine factors associated with receiving advice. Analyses comprised only complete cases with regard to the analysed variables. Results are expressed as odds ratios (ORs) with 95% confidence intervals (95% CI).
Of the 1,627 analysed patients (median age 77; range 72-93 years; 52.5% women), 534 (32.8%) stated that they had been advised to get regular physical activity. In the adjusted model, those more likely to receive GP advice on physical activity were men (OR [95% CI] 1.34 [1.06-1.70]), patients suffering from pain (1.43 [1.13-1.81]), coronary heart disease and/or myocardial infarction (1.56 [1.21-2.01]), diabetes mellitus (1.79 [1.39-2.30]) or arthritis (1.37 [1.08-1.73]), and patients taking a high (> 5) number of medications (1.41 [1.11-1.80]).
The study revealed a relatively low rate of older primary health care patients receiving GP advice on physical activity. GPs appeared to focus their advice on patients with chronic medical conditions. However, there are likely to be many more patients who would benefit from advice.
PMCID: PMC3115873  PMID: 21569227
aged; physical activity; family physicians; primary health care; chronic disease; public health

Results 1-6 (6)