Rubenstein 2000.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 3 months |
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| Participants | Setting: California, USA Number of participants: 59 Number analysed: 59 Number lost to follow‐up: 0 Sample: men recruited from Veterans Administration ambulatory care centre (volunteers) Age (years): mean 74 Sex: 0% female Inclusion criteria: aged ≥ 70; ambulatory; ≥ 1 fall risk factor: lower limb weakness, impaired gait, impaired balance, > 1 fall in previous 6 months Exclusion criteria: exercised regularly; severe cardiac or pulmonary disease; terminal illness; severe joint pain; dementia; medically unresponsive depression; progressive neurological disease |
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| Interventions | 1. Group‐based balance, strength and endurance: using free weights, elastic bands, bicycle, treadmill; 90 minutes, 3 a week for 12 weeks 2. Control: usual activities | |
| Outcomes | 1. Rate of falls
2. Number of people who experienced 1 or more falls (risk of falling) 3. Health‐related quality of life |
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| Duration of the study | 12 weeks | |
| Adherence | Adherence measured by session attendance 1. Group‐based balance, strength and endurance group: attended 84% of the exercise sessions |
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| Notes | Source of funding: Department of Veterans Affairs, Health Services Research and Development Service, Disabled American Veterans Charities of Greater Los Angeles Economic information: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised in blocks of 16 to 20 at 3‐ to 6‐month intervals, using randomly‐generated sequence cards in sealed envelopes |
| Allocation concealment (selection bias) | Unclear risk | Cards in sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel implementing the intervention not blind to allocated group, but impact of non‐blinding unclear |
| Blinding of outcome assessment (detection bias) Falls | High risk | Falls reported by participants who were aware of their group allocation. Fall data were gathered in different settings for the intervention and control goups. The person ascertaining falls was aware of group allocation |
| Blinding of outcome assessment (detection bias) Fractures | Unclear risk | Method of recording fractures is unclear |
| Blinding of outcome assessment (detection bias) Hospital admission, medical attention and adverse events | Unclear risk | Method of recording adverse events is 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 | No missing fall data |
| Selective reporting (reporting bias) | Unclear risk | Falls were prespecified in Methods section and reported in Results. Adverse events not prespecified. No protocol paper or prospective trial registration |
| Method of ascertaining falls (recall bias) | Unclear risk | No active fall registration. Fall ascertainment for intervention group at weekly classes. Controls phoned every 2 weeks |