Kamide 2009.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 6 months |
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Participants | Setting: Kanagawa, Japan Number of participants: 57 Number analysed: 43 Number lost to follow‐up: 14 Sample: women registered at an employment agency for older people (see Notes) Age (years): mean 71 (SD 3.6) Sex: 100% female Inclusion criteria: aged ≥ 65 years; community‐dwelling; independently mobile; no restriction on physical activities Exclusion criteria: cerebrovascular, cardiopulmonary, neuromuscular, liver, or kidney disease; hyperparathyroidism; unstable diabetes mellitus or hypertension; fracture of spine or lower limbs; taking prednisolone; exercising regularly |
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Interventions | 1. Individual balance and strength training: home‐based exercises, Theraband used for moderate‐intensity lower‐limb strength training, no home visits but monthly telephone or mail contact; performed ≥ 3 days a week for 24 weeks 2. Control: usual activities, telephone or mail contact from PT every 3 months |
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Outcomes | 1. Number of people who experienced 1 or more falls (risk of falling) | |
Duration of the study | 52 weeks | |
Adherence | Adherence measured as frequency of sessions completed 1. Individual balance and strength training group: 19 of 23 (83%) intervention participants completed > 3 a week, 21 of 23 (91%) intervention participants completed > 2 a week |
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Notes | Source of funding: Univers Foundation, Tokyo Economic information: not reported Employment agency providing light work or volunteer activities for older people and encouraging social activities |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The random assignment procedure was performed using random numbers generated by a computer program ..." |
Allocation concealment (selection bias) | Unclear risk | Quote: "The subjects were randomly assigned to either the home‐based exercise group or the control group". Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and therapists aware of group allocation. Intervention group: Quote: "the therapist contacted each subject by telephone or mail every month to maintain their motivation." Control group: Quote: "The subjects who were assigned to the control group were instructed to continue with their usual daily activities, with no restrictions on their exercise activities. A therapist contacted them every 3 months by telephone or mail." |
Blinding of outcome assessment (detection bias) Falls | Unclear risk | Quote: "Functional capacity, physical function, and bone mineral density were assessed in all subjects in both groups before and after the 6‐month intervention. The staff performing the assessments were blinded to each subject's group assignment. Falls were also assessed before and after the 12‐month followup." Unclear if assessors were blinded. Assume method of fall asessment was the same in both groups |
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 (25%). |
Selective reporting (reporting bias) | High risk | Falls were measured, but number of falls not reported |
Method of ascertaining falls (recall bias) | High risk | Quote: "Falls were also assessed before and after the 12‐month followup." No concurrent recording described. No mention of frequent telephone monitoring |