Kim 2014.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months |
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Participants | Setting: Tokyo, Japan Number of participants: 105 Number analysed: 103 Number lost to follow‐up: 2 Sample: community‐dwelling women Age (years): Intervention mean 77.83 (SD 4.21), Control mean 77.83 (SD 4.15) Sex: 100% female Inclusion criteria: age ≥ 70 years; experienced at least 1 fall incident in the previous year; and no missing fall‐related baseline data Exclusion criteria: severe knee or back pain; severe walking disability; and unstable cardiac conditions |
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Interventions | 1. Group‐based balance and strength: increased difficulty of exercises, used resistance bands or ankle weights for strength training; 60‐minute, 2 a week for 3 months; plus 1‐hour exercise classes 1 a month during 1‐year follow‐up; home programme encouraged ≥ 3 a week during 1‐year follow‐up 2. Control group: Health education. 60‐minute class once a month for 3 months, a total of 3 times |
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Outcomes | 1. Number of people who experienced 1 or more falls (risk of falling) 2. Number of people who experienced 1 or more fall‐related fractures |
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Duration of the study | 52 weeks | |
Adherence | Adherence measured as session attendance, frequency of home exercises, mean exercise time 1. Group‐based balance and strength group: mean attendance rate during intervention, 75% (range 64 – 86%); mean frequency home exercises 3.4 a week; mean exercise time 24.9 minutes |
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Notes | Source of funding: Ministry of Health and Welfare of Japan, Japan Society for the Promotion of Science Economic information: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
Allocation concealment (selection bias) | Unclear risk | Quote: "The allocation process was blinded". Insufficient information to permit judgement. |
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 | Fall diaries were collected at 1‐year follow‐up Quote: "The investigators evaluating the effects of the exercise treatment were blind to intervention allocations" |
Blinding of outcome assessment (detection bias) Fractures | High risk | Participants were asked about fractures by face‐to‐face interview at baseline, 3 month and 1 year. No radiological confirmation |
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 | Low risk | Less than 20% of fall outcome data are missing (2%). Missing data were balanced between the exercise (n = 2) and control (n = 1) groups, with reasonable reasons for loss of data in the 2 groups (exercise: reduced motivation = 1, hospitalisation = 1; control: moved house = 1) |
Selective reporting (reporting bias) | High risk | Falls were measured, but number of falls was not reported. Adverse events were not reported |
Method of ascertaining falls (recall bias) | Unclear risk | Falls diary, distributed at 3‐month assessment and collected at 1‐year follow‐up |