Boongrid 2017.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months | |
| Participants | Setting: Bangkok, Thailand Number of participants: 439 Number analysed: 437 Number lost to follow‐up: 2 Sample: community‐dwelling Age (years): mean 73.8 (SD 6.7) Sex: 83% female Inclusion criteria: ≥ 65 years, mild‐to‐moderate balance dysfunction, able to provide written informed consent. Exclusion criteria: moderate‐to severe cognitive problems, a neurological condition that severely influenced their gait and mobility (e.g. Parkinson’s disease, stroke with hemiparesis), acute arthritis, any unstable or terminal illnesses that would preclude the planned exercises and were unlikely to resolve, unable to communicate well in Thai, already participating in regular strengthening exercise (e.g. yoga, Tai Chi) |
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| Interventions | 1. Individual Otago Exercise Programme and walking plan; video disk, manuals and weekly calendars provided, telephone calls every 2 weeks, and home visit in 3, 6, 9, 12 months 2. Control group: no intervention Both groups received fall prevention education and home safety information through video disk recorder media and books |
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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 proportion exercising ≥120 minutes a week at 3 months 1. Individual Otago Exercise Programme and walking plan group: 30% exercised ≥ 120 minutes a week at 3 months; 32% exercised ≥ 120 minutes a week at 6 months; 57% exercised ≥ 120 minutes a week at 3 months |
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| Notes | Source of funding: Development potentials of Thai People Project, Mahidol University Economic information: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "A block randomization was applied to generate random sequence lists by an investigator who was not involved in data collection or administering interventions" |
| Allocation concealment (selection bias) | Low risk | Opaque sealed envelopes and sequence kept confidential |
| 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 were recorded on daily calendar in all groups. Research assistants who conducted interviews were 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 | Method of ascertaining adverse events is unclear |
| Blinding of outcome assessment (detection bias) Health related quality of life (self report) | High risk | Participants were not blind to allocated group |
| Incomplete outcome data (attrition bias) Falls and fallers | Low risk | Less than 20% of outcome data are missing (< 1%). Balanced losses in intervention and control groups |
| Selective reporting (reporting bias) | Low risk | Outcomes prespecified in study protocol were reported. Adverse events not specified in protocol but were reported in results |
| Method of ascertaining falls (recall bias) | Low risk | Falls were self‐recorded on a daily calendar, plus interviews by blinded research assistants at 3, 6, 9 and 12 months |