| Study characteristics |
| Methods |
RCT (cluster‐randomised by living facility) |
| Participants |
Setting: Atlanta, USA
N = 311 (N = 20 clusters)
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 (94% women)
Age (years): mean 80.9 (SD 6.2), range 70 to 97
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 |
| Interventions |
1. Intense Tai Chi (TC): 6 out of 24 simplified TC forms. 1 hour progressing to 90 min, 2 x per wk (10 to 50 min of TC) for 48 wks. Progressing from using upright support to 2 min of TC without support
2. Wellness education programme: 1 hour per wk for 48 wks. 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 |
| Outcomes |
1. Rate of falls
2. Number of people falling |
| Duration of the study |
48 wks of intervention. Methods paper (Wolf SL et al. Controlled Clinical Trials 2001;22:689‐704) describes follow‐up for 1 year post intervention by weekly phone calls but not reported in Wolf 2003 or subsequently. |
| Notes |
"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 M et al. J Am Geriatr Soc 1991;39:46‐52) |
| 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 |
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 blind to allocated group, but impact of non‐blinding unclear |
| Blinding of outcome assessment (detection bias)
Falls and fallers |
Low risk |
Falls reported by participants who were aware of their group allocation. Outcome assessors blinded to assignment. |
| Incomplete outcome data (attrition bias)
Falls |
Unclear risk |
SeeAppendix 3 for method of assessment |
| Incomplete outcome data (attrition bias)
Fallers |
Low risk |
SeeAppendix 3 for method of assessment |
| Risk of bias in recall of falls |
Low risk |
Prospective. Falls recorded on forms and submitted to instructor weekly + phone call. |
