Clemson 2012.
| Methods | Study design: RCT Number of study arms: 3 Length of follow‐up: 12 months | |
| Participants | Setting: Sydney, Australia Number of participants: 317 Number analysed: 317 Number lost to follow‐up: 0 Sample: community‐dwelling Age (years): mean 83.4 Sex: 55% female Inclusion criteria: men and women ≥ 70 yrs, ≥ 2 falls or 1 injurious fall in past 12 months determined by self‐report Exclusion criteria: moderate to severe cognitive problems, no conversational English, inability to walk independently, neurological condition severely influencing gait and mobility, resident in a nursing home or hostel, unstable or terminal medical illness precluding the planned exercises and unlikely to resolve |
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| Interventions | 1. LiFE (Lifestyle approach to reducing Falls through Exercise) programme ‐ progressive balance and strength training embedded in daily life activities: performed throughout the day, taught in 5 home visits + 2 booster visits over 3 months + 2 phone calls. Manual provided for increasing intensity and challenge. 6‐month programme. 2. Individual balance and strength training: progressive exercises performed 3 a week, taught in 5 home visits + 2 booster visits over 3 months + 2 phone calls. 6‐month programme. 3. Control: Low‐intensity flexibility and balance training; gentle and flexibility exercises in sitting, lying down, or standing while holding on, not progressed, 2 sessions + 1 booster session + 6 follow‐up phone calls. 6 months |
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| Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) 3. Health‐related quality of life 4. Number of people who died |
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| Duration of the study | 52 weeks | |
| Adherence | Adherence measured by sessions performed. Mean adherence to programme over first 6 months for each group/still exercising at 6 months reported: 1. LiFE (Lifestyle approach to reducing Falls through Exercise) programme group: 47% (SD 33)/81 (76%) 2. Individual balance and strength training group: 35% (SD 29)/63 (60%) 3. Control group: 47% (SD 34)/74 (71%) |
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| Notes | Source of funding: Australian National Health and Medical Research Council Economic information: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
| Allocation concealment (selection bias) | Low risk | Quote: "Randomisation was ... concealed by using an automated secure website that was operated by an off‐site independent service" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel unblinded but impact of unblinding unknown |
| Blinding of outcome assessment (detection bias) Falls | Low risk | Fall data collected using same method in each group. Fall event surveillance was conducted by a research assistant blinded to group allocation |
| 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) | High risk | Participants unblinded to group allocation |
| Incomplete outcome data (attrition bias) Falls and fallers | Unclear risk | Less than 20% of fall outcome data are missing (10%). Minor imbalance in withdrawals in LiFE (n = 8), structured programme (n = 9) and control (n = 14) groups, with reasons for loss of fall data unclear |
| Selective reporting (reporting bias) | Low risk | Falls outcomes were prospectively specified in trial registry. Adverse events reported |
| Method of ascertaining falls (recall bias) | Low risk | Daily calendar mailed monthly, follow‐up phone call for missing calendars or fall reported by blinded researcher |