Lord 2003.
| Methods | RCT. Cluster‐randomised by village. Stratified by accommodation (self‐care or intermediate care) and by cluster size (< 75 or at least 75 residents) Study design: Cluster‐RCT Number of study arms: 2 Number of clusters: 20 Length of follow‐up: 12 months |
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| Participants | Setting: retirement villages, Sydney, Australia Number of participants: 551 Number analysed: 508 Number lost to follow‐up: 43 Sample: recruited from self‐care apartment villages (78%) and intermediate‐care hostels (22%) Age (years): mean 79.5 (SD 6.4), range 62 ‐ 95 Sex: 86% female Inclusion criteria: resident in one of 20 retirement villages Exclusion criteria: MMSE < 20; already attending exercise classes of equivalent intensity; medical conditions that precluded participation as determined by nurse or physician (neuromuscular, skeletal, cardiovascular); in hospital or away at recruitment time |
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| Interventions | Randomised into 3 groups: 1 intervention group (group‐based balance, strength, gait training) and 2 control groups (1 seated flexibility and relaxation activities, 1 no group activity). Only the intervention group and control group with no activity included in this review 1. Group‐based balance, strength, gait training: within village site, instructor‐led class not requiring any special equipment; 1 hour, 2 a week for 52 weeks 2. Control: no group activity |
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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 died |
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| Duration of the study | 52 weeks | |
| Adherence | Adherence measured by class attendance, range for both groups 0‐100%. 1. Group‐based balance, strength, gait training: mean number of classes attended 42%; IQR: 10 ‐ 62 classes 2. Control group: mean number of classes attended 45%; IQR: 6 ‐ 50 classes |
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| Notes | Source of funding: National Health and Medical Research Council of Australia, New South Wales Health, MBF (Australia) Economic information: not reported Number of clusters allocated to intervention: 10; number of clusters allocated to control: 10; number of clusters analysed (intervention): 10; number of clusters analysed (control): 10 Email communication to obtain fall data, response received, data included in review |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation not described |
| Allocation concealment (selection bias) | High risk | Cluster‐RCT. Individual participant recruitment was undertaken after group allocation. The method of concealment is not described and it is likely that recruitment was undertaken by a person who was unblinded and may have known participant characteristics |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel not blinded to allocated group but impact of non‐blinding unclear |
| Blinding of outcome assessment (detection bias) Falls | High risk | Falls reported by completion of questionnaire monthly by all participants; if not returned telephone calls were made. No mention of blinding of personnel carrying out phone calls, but in intermediate‐care sites, falls record book was kept by nursing staff (unblinded) |
| 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 | High risk | More than 20% of fall data were missing (43%) |
| Selective reporting (reporting bias) | Unclear risk | Minimum set of expected outcomes not reported (adverse events not reported) |
| Method of ascertaining falls (recall bias) | Low risk | Retrospective. Falls ascertained by questionnaires given to residents every month, with follow‐up phone calls or home visit for non‐responders. In addition nurses recorded falls in falls record book in intermediate‐care hostels |
| Cluster‐randomised trials | Unclear risk | Individuals were recruited to the trial after the clusters were randomised. Personnel recruiting participants were not blind to cluster; baseline comparison of the intervention arms is reported, but not baseline comparability of clusters; missing outcomes for clusters or within clusters were not reported; accounted for the clustered design in the analysis; results comparable with individually‐randomised trials |