Sakamoto 2013.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 6 months |
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| Participants | Setting: Japan Number of participants: 1365 Number analysed: 865 Number lost to follow‐up: 500 Sample: community‐dwelling Age (years): Intervention: male: mean 80.5 (SD 4.1); female: mean 80.1 (SD 4) Control: male: mean 80.7 (SD 4); female: mean 80.5 (SD 4.1) Sex: 82% female Inclusion criteria: > 75 years of age, lived at home and visited an orthopaedic clinic or hospital for an orthopaedic handicap and could stand on 1 leg (both right and left, with the eyes open for ≤ 15 seconds (the Ministry of Health, Labour, and Welfare of Japan designates men and women 75+ years of age who can stand on 1 leg with eyes open for ≤ 15 s as having musculoskeletal ambulation disability symptom complex), ability to communicate and those who could continue training Exclusion criteria: People with Parkinson’s disease or other conditions that made them susceptible to falls, people with artificial joints, and people with cognitive disorders |
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| Interventions | 1. 1‐leg stand balance training: trained each leg with eyes open for 1 minute, 3 a day for 6 months 2. Control group: no intervention |
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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 experienced 1 or more fall‐related fractures |
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| Duration of the study | 26 weeks | |
| Adherence | Not reported | |
| Notes | Source of funding: Ministry of Health, Labour, and Welfare of Japan Economic information: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The 10 x 5 (= 50) random number tables with 5 x 5 (25) numbers were prepared and 2 ten‐faced dice (one green, one yellow) were thrown to decide which table to use. Two six‐faced dice were then thrown to select the number within the chosen random number table to decide whether the institution would be designated an exercise or non‐exercise institution" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to make judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding not specified but assume participants and personnel were unblinded. Impact of unblinding unknown |
| Blinding of outcome assessment (detection bias) Falls | Unclear risk | The record of falls/exercise was checked at an outpatient orthopaedic clinic monthly. Blinding not specified |
| Blinding of outcome assessment (detection bias) Fractures | Unclear risk | Self‐report on calendar, then fracture was confirmed and recorded by a doctor. Unclear if doctor was blinded to group |
| Blinding of outcome assessment (detection bias) Hospital admission, medical attention and adverse events | Unclear risk | Participants surveyed at 6 months for adverse events. Blinding not specified |
| 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 data missing (37%) |
| Selective reporting (reporting bias) | Unclear risk | Falls and adverse events were prespecified in Methods section and reported in Results. No protocol paper or prospective trial registration |
| Method of ascertaining falls (recall bias) | Low risk | Instructed to record exercise/falls/fracture every day. The record was checked at the time of examination at outpatient orthopaedic clinic once a month |