Yamada 2012.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months |
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Participants | Setting: Japan Number of participants: 157 Number analysed: 145 Number lost to follow‐up: 12 Sample: community‐dwelling Age (years): mean 86 Sex: 81% female Inclusion criteria: ≥ 75 years old, community‐dwelling, had visited a primary care physician within the past 3 years, no severe cognitive impairment, walk independently (or with a cane), willingness to participate in group exercise classes for at least 6 months, had access to transportation, no significant hearing and vision impairments, no regular exercise in the past 12 months Exclusion criteria: severe cardiac, pulmonary or musculoskeletal disorders, co‐morbidities associated with greater risk of falls, such as Parkinson disease and stroke, and use of psychotropic drugs |
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Interventions | 1. Group‐based balance, strength, flexibility and gait training involving complex obstacle course: 45‐minute exercise session ('moderate‐intensity' aerobic‐dance exercise, progressive strength training using elastic band, progressive balance exercises); plus walking as quickly as possible in a progressively difficult field of obstacles 2 times a session. 1 session a week for 24 weeks 2. Group‐based balance, strength, flexibility and gait training involving simple obstacle course: 45‐minute exercise session ('moderate‐intensity' aerobic‐dance exercise, progressive strength training using elastic band, progressive balance exercises); plus walking at a self‐selected speed along a simple level walkway of 15 m with obstacles 6 times a session. 1 session a week for 24 weeks |
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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 experienced 1 or more fall‐related fractures |
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Duration of the study | 52 weeks | |
Adherence | Adherence measured by completion of programme 1. Group‐based balance, strength, flexibility and gait training involving complex obstacle course group: median relative adherence; 96% (25th ‐ 75th percentile, 88 – 100%) 2. Group‐based balance, strength, flexibility and gait training involving simple obstacle course group: median relative adherence; 96% (25th ‐ 75th percentile, 88 – 100%) |
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Notes | Source of funding: not reported Economic information: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Methods not described |
Allocation concealment (selection bias) | Low risk | Quote: "Opaque envelopes bearing group names were numbered" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel implementing the intervention not blinded to allocated group, but impact of non‐blinding unclear |
Blinding of outcome assessment (detection bias) Falls | Unclear risk | Not specifically reported if the research assistants collecting fall outcomes were blinded Quote: "research assistants collected fall outcomes… a physiotherapist blinded to group allocation collected secondary outcome measures" |
Blinding of outcome assessment (detection bias) Fractures | Unclear risk | Quote: “The diagnosis of fractures was based on radiological evidence of fracture”. Unclear if assessors were blinded to group allocation |
Blinding of outcome assessment (detection bias) Hospital admission, medical attention and adverse events | Unclear risk | Method of measuring adverse events was unclear |
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 data were missing (8%). The missing data were balanced between groups, with 6 withdrawals from each group. The reasons for withdrawals were unclear |
Selective reporting (reporting bias) | Unclear risk | Minimum set of expected outcomes reported. No published study protocol or prospective trial registration |
Method of ascertaining falls (recall bias) | Low risk | Quote: "The participants were asked to record any falls in fall diaries mailed every month by research assistants. If participants failed to send the fall diaries, research assistants collected data on falls over the telephone" |