Yamada 2010.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months |
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Participants | Setting: Kyoto, Japan Number of participants: 60 Number analysed: 58 Number lost to follow‐up: 2 Sample: people recruited using advertising in local press (proportion of women not stated) Age (years): not stated Inclusion criteria: aged ≥ 65; community‐dwelling; visited primary care physician in previous 3 years; MMSE ≥ 24; able to walk independently (with or without a cane): willing to participate in group exercise classes lasting ≥ 6 months; access to transportation; minimal hearing and visual impairments; no regular exercise in previous 12 months Exclusion criteria: severe cardiac pulmonary, or musculoskeletal disorders; neurological conditions associated with falling (stroke, Parkinson's disease); osteoporosis; use of psychotropic drugs |
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Interventions | 1. Group‐based trail walking training: 90‐minute class (moderate intensity aerobic exercise, progressive strengthening with rubber band, flexibility and balance exercises) including trail walking between flags as quickly as possible, 1 a week for 16 weeks 2. Group‐based indoor walking: 90‐minute class (moderate‐intensity aerobic exercise, progressive strengthening with rubber band, flexibility and balance exercises) including supervised indoor walking session at a comfortable pace (up to 30 minute on 300‐foot loop); 1 a week for 16 weeks |
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Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) |
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Duration of the study | 52 weeks | |
Adherence | Adherence measured by completion of 16 scheduled sessions 1. Group‐based trail walking training: median relative adherence; 100% (25th – 75th percentile, 94 – 100%) 2. Group‐based indoor walking: median relative adherence; 100% (25th – 75th percentile, 94 – 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 | Quote: "Participants were block randomized in blocks of four" |
Allocation concealment (selection bias) | Low risk | Quote: "Using this sequence, opaque envelopes bearing group names were numbered and the 60 participants were then randomly as signed to the TWE (n = 30) or walking (W) group (n = 30)" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Both groups received an exercise intervention. Unclear whether there was any risk of performance bias |
Blinding of outcome assessment (detection bias) Falls | Unclear risk | Unclear whether person ascertaining falls was blinded to allocated group |
Blinding of outcome assessment (detection bias) Fractures | Unclear risk | Not applicable |
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 | Unclear risk | Less than 20% of fall data were missing (3%). The missing data were balanced between groups, with 1 withdrawal from each group |
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 that were mailed to the research assistants every month." |