Wolf 2003.
| Methods | Study design: Cluster‐RCT Number of study arms: 2 Number of clusters: 20 Length of follow‐up: 11 months |
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| Participants | Setting: Atlanta, USA Number of participants: 311 Number analysed: 286 Number lost to follow‐up: 25 Sample: congregate living facilities (independent living facilities) recruited in pairs by whether Housing and Urban Development (N = 14) or private (N = 6). At least 15 participants recruited per site Age (years): mean 80.9 (SD 6.2), range 70 to 97 Sex: 94% female Inclusion criteria: aged ≥ 70; ≥ 1 fall in previous year; transitioning to frailty Exclusion criteria: frail or vigorous elderly; major cardiopulmonary disease; cognitive impairment (MMSE < 24); contraindications for exercise, e.g. major orthopaedic conditions; mobility restricted to wheelchair; terminal cancer; evidence of other progressive or unstable neurological or medical conditions |
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| Interventions | 1. Group‐based Tai Chi: progressed from using upright support to 2 minutes of Tai Chi without support; 1‐hour class progressing to 90 minutes, 2 a week for 48 weeks 2. Control group: wellness education programme (Instruction on fall prevention, exercise and balance, diet and nutrition, pharmacological management, legal issues, changes in body function, mental health issues. Interactive material provided but no formal instruction in exercise); 1 hour a week for 48 weeks | |
| 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 | 48 weeks | |
| Adherence | Adherence measured by group attendance 1. Group‐based Tai Chi group: mean attendance rate; 76 ± 19% (range 6 ‐ 100%) 2. Control group: mean attendance rate; 81 ± 17% (range 10 ‐ 100%) |
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| Notes | Source of funding: NIH Grant Economic information: not reported "Transitioning to frailty" if not vigorous or frail; based on age, gait/balance, walking activity for exercise, other physical activity for exercise, depression, use of sedatives, vision, muscle strength, lower extremity disability (Speechley 1991) 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 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Facilities stratified by socioeconomic status and randomised in pairs Quote: "First site in the pair was randomized to an intervention. The second site received the other intervention" |
| Allocation concealment (selection bias) | Unclear risk | Cluster‐RCT. Insufficient information to permit judgement, although allocation of second site in the pair could be predicted after the first site was randomised |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear 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 | Low risk | Falls reported using the same method in each group. Outcome assessors blinded to assignment |
| 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 | The method of ascertaining 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%). Missing data were balanced across groups (13/158 missing from the intervention group and 12/153 missing from the control group) and the reasons for missing data were balanced across groups |
| 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 | Prospective. Falls recorded on forms and submitted to instructor weekly + phone call |
| Cluster‐randomised trials | Unclear risk | The relative timing of the randomisation of clusters and recruitment of participants is unclear; baseline characteristics of clusters not reported; missing outcomes for clusters or within clusters were not reported; accounted for the clustered design in the analysis; results comparable with individually‐randomised trials |