Shigematsu 2008.
| Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 8 months |
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| Participants | Setting: Kawage, Mie, Japan Number of participants: 68 Number analysed: 68 Number lost to follow‐up: 0 Sample: randomly‐selected people meeting inclusion criteria Age (years): mean 69 (SD 3) Sex: 63% female Inclusion criteria: 65 ‐ 74 years old; community‐dwelling Exclusion criteria: severe neurological or cardiovascular disease; mobility‐limiting orthopaedic conditions |
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| Interventions | 1. Group‐based stepping training on felt mat: step direction and performance progressed on felt mat at own pace, 70‐minute sessions, 2 a week for 12 weeks; group "divided" at 12 weeks and continued sessions for a further 12 weeks 2. Group‐based walking: instructed to increase number of daily steps in supervised outdoor walking, 40‐minute sessions, 1 a week for 12 weeks; as above, group divided and half continued walking for a further 12 weeks | |
| Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) | |
| Duration of the study | 52 weeks with 32 weeks follow‐up after the intervention | |
| Adherence | Adherence measured by session attendance 1. Group‐based stepping training on felt mat: participants attended 21.8 ± 2.9 of 24 sessions (90.9% ± 12.1%) Dropouts: 0. The participants conscientiously exercised for 40 minutes throughout the regimen 2. Group‐based walking: participants attended 9.3 ± 2.6 of 11 sessions (84.2% ± 23.7%). Dropouts: 5 |
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| Notes | Source of funding: not reported 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: "Randomly allocated.. by a public health nurse who used a computerized random number generation program in which the numbers 0 and 1 corresponded to the two groups, respectively" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study described as "single‐blind", presumably meaning that participants were blind to whether they were in the intervention or control groups as both groups received an exercise intervention. Treatment personnel presumably unblinded but judged that lack of blinding unlikely to introduce bias |
| Blinding of outcome assessment (detection bias) Falls | High risk | Study described as "single‐blind" because both groups received an exercise intervention. Assessors presumably unblinded |
| 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 | Low risk | No missing fall data |
| Selective reporting (reporting bias) | Unclear risk | Prespecified falls outcomes reported. Adverse events were reported but not prespecified. No protocol paper or trial registration |
| Method of ascertaining falls (recall bias) | Low risk | Quote: "All the persons received a pre‐paid postcard at the beginning of each month, which they returned at the beginning of the next month". Instructed to record falls on a daily basis. Phoned or face‐to‐face interview if falls reported |