Kemmler 2010.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 18 months |
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Participants | Setting: Erlangen‐Nuremberg area, Germany Number of participants: 246 Number analysed: 227 Number lost to follow‐up: 19 Sample: female members of Siemens Health Insurance living in Erlangen‐Nuremberg area Age (years): mean 69 (SD 4) Sex: 100% female Inclusion criteria: aged ≥ 65; community‐dwelling; consenting Exclusion criteria: diseases affecting bone metabolism or fall risk; medication affecting bone metabolism or fall risk; history of profound coronary heart diseases (stroke, cardiac events), acute or chronic inflammatory diseases, or secondary osteoporosis; participation in exercise studies during previous 2 years; very low physical capacity (< 50 W during ergometry) |
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Interventions | 1. Group‐based balance, gait, flexibility and strength training plus home practice: progressive high‐intensity exercise programme (aerobic dance, static and dynamic balance training, functional gymnastics, isometric strength training, and stretching for trunk, hip, and thigh, and upper body exercises using elastic belts), 60‐minute, 2 a week; plus progressive strength and flexibility home exercises, 20‐minute, 2 a week for 18 months 2. Group‐based low‐intensity, low‐frequency balance and endurance training: low‐ to moderate‐intensity "Wellness programme" (relaxation, games/interaction, general co‐ordination, endurance, balance, dances, body sensitivity, muscle strength, breathing, and flexibility); 1 hour, 1 a week for 10 weeks then 10 week rest |
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Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) 3. Number of people who died |
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Duration of the study | 72 weeks | |
Adherence | Adherence measured as session attendance, frequency of home training 1. Group‐based balance, gait, flexibility and strength training plus home practice: mean attendance rate, 76% (SD 8%) group training, 42% (SD 5%) for home training 2. Control: mean attendance rate, 72% (SD 9%) |
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Notes | Source of funding: Siemens Betriebs Krankenkasse, Behinderten‐ und Rehabilitations‐ Sportverband Bayern, Netzwerk Knochengesundheit e.V., Opfermann Arzneimittel GmbH, Thera‐Band, Institute of Sport Science, Institute of Medical Physics Economic information: Mean total healthcare service costs: Exercise group EUR 2255, Control group EUR 2780 Cost analysis in primary reference |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Computer‐generated block randomization" |
Allocation concealment (selection bias) | Low risk | Quote: "The allocation sequence and group assignment were performed by the Institute of Biometry and Epidemiology. Participants were enrolled by the Institute of Medical Physics" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The study was blinded for the outcome assessors and participants ..." "To blind the participants, the control group performed a program that focused on well‐being and was designed not to cause physical adaptations" "The effectiveness of the blinding in the control group was proven in structured interviews conducted by the primary investigators at the end of the 18 months". Assume no blinding of personnel; impact is unclear |
Blinding of outcome assessment (detection bias) Falls | Low risk | Falls assessed using same method for all participants. Outcome assessors were blind to allocation |
Blinding of outcome assessment (detection bias) Fractures | High risk | Quote: "Injurious falls and overall fractures were monitored daily with the use of fall calendars compiled by the participants. Outcome assessors contacted subjects who fell and nonresponders monthly by telephone". No report of radiological confirmation of fractures |
Blinding of outcome assessment (detection bias) Hospital admission, medical attention and adverse events | Unclear risk | Not applicable |
Blinding of outcome assessment (detection bias) Health related quality of life (self report) | Unclear risk | Not applicable |
Incomplete outcome data (attrition bias) Falls and fallers | Low risk | Less than 20% of fall outcome data are missing (8%). Missing data were balanced between high‐intensity (n = 8) and low‐intensity (n = 11) groups, with balanced reasons for loss of data in the 2 groups |
Selective reporting (reporting bias) | High risk | Falls were measured, but number of falls was not reported. Adverse events were not reported |
Method of ascertaining falls (recall bias) | Low risk | Quote: "Injurious falls and overall fractures were monitored daily with the use of fall calendars compiled by the participants. Outcome assessors contacted subjects who fell and nonresponders monthly by telephone." |