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. 2019 Jan 31;2019(1):CD012424. doi: 10.1002/14651858.CD012424.pub2

Kemmler 2010.

Methods Study design: RCT
Number of study arms: 2
Length of follow‐up: 18 months
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)
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
Outcomes 1. Rate of falls
2. Number of people who experienced 1 or more falls (risk of falling)
3. Number of people who died
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%)
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
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."