Hwang 2016.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 18 months |
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Participants | Setting: Taipei, Taiwan Number of participants: 456 Number analysed: 334 Number lost to follow‐up: 122 Sample: community‐dwelling Age (years): mean 72 Sex: 67% female Inclusion criteria: aged ≥ 60 who received fall‐related medical attention ‐ an older person was presumed to have recovered from a fall injury within 6 months and who could walk independently were invited by telephone to enrol in the study and participate in the baseline assessment Exclusion criteria: major unstable cardiopulmonary disease (ischaemic chest pain or shortness of breath on mild exertion), cognitive impairment (MMSE score < 24), and contraindications to physical exercise (e.g. severe arthritis that limits exercise capability) |
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Interventions | 1. Individually‐supervised Tai Chi: taught individually each week for 24 consecutive weeks, 60‐minute sessions, 1 a week for 6 months 2. Individually‐supervised balance and strength training: exercises at increasing difficulty levels using own body weight; 60‐minute sessions, 1 a week for 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. Number of people who died |
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Duration of the study | 72 weeks | |
Adherence | Adherence measured as participation in sessions 1. Individually‐supervised Tai Chi group: 145 (78%) people participated in 20 or more sessions 2. Supervised balance and strength training group: 132 (72%) people participated in 20 or more sessions |
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Notes | Source of funding: National Health Research Institute, Ministry of Science Technology Economic information: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Statisticans using computer‐generated sequence; block‐randomised in groups of 8 |
Allocation concealment (selection bias) | Low risk | Using an automated secure website 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 | Research assistants who conducted fall‐related phone calls were blinded to 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) | Unclear risk | Not applicable |
Incomplete outcome data (attrition bias) Falls and fallers | High risk | More than 20% of fall outcome data are missing (27%) |
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 | Quote: "Falls were prospectively monitored and recorded daily using a diary, and these records were mailed monthly to the study coordinator." "When a participant failed to return the diary or provided incomplete data, two research assistants blinded to the group assignment provided telephone reminders, making a maximum of five calls. Monthly follow‐up of fall records was continued in participants who were unavailable for certain periods". |