Kamide 2009.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: Kanagawa, Japan
N = 57
Sample: women registered at an employment agency for older people (see Notes)
Age (years): mean 71 (SD 3.6)
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. Home‐based exercise at least 3 days/wk for 24 wks. Initial 1‐hour educational session plus 1‐hour exercise instruction by PT. Exercise: stretching, moderate intensity lower‐limb strength training, balance training, impact training. No home visits but telephone or mail contact monthly. 2. Control: usual activities. Telephone or mail contact from PT every 3 months |
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Outcomes | 1. Number of people falling | |
Duration of the study | Falls data for previous 6 months collected retrospectively at the end of 12 months follow‐up | |
Notes | Employment agency providing light work or volunteer activities for older people and encouraging social activities | |
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 with potential for performance bias. Intervention group: "the therapist contacted each subject by telephone or mail every month to maintain their motivation." Control group: "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 and fallers | Low 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." |
Incomplete outcome data (attrition bias) Falls | Unclear risk | SeeAppendix 3 for method of assessment |
Incomplete outcome data (attrition bias) Fallers | High risk | SeeAppendix 3 for method of assessment |
Risk of bias in recall of falls | High risk | Quote: "Falls were also assessed before and after the 12‐month followup." No concurrent recording described. No mention of frequent telephone monitoring. |