Kyrdalen 2014.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 3 months |
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Participants | Setting: 11 communities in southeast Norway Number of participants: 125 Number analysed: 94 Number lost to follow‐up: 31 Sample: community‐dwelling Age (years): mean 82.5 (SD 5.7) Sex: 73% female Inclusion criteria: home‐dwelling, at increased fall risk (defined as answering yes on either criterion 1 or 2 below, and in addition yes on 2 or more of criteria 3 ‐ 9: 1) had fallen at least once during the previous 12 months; 2) had self‐reported balance or gait problems; 3) had Parkinson’s disease or had suffered a stroke; 4) had 4+ concomitant diseases; 5) needed a handrail or support while rising from a chair; 6) used 4+ prescribed medications; 7) had reduced cognitive function as assessed by a geriatrician; 8) had BMI < 20, and 9) had reduced vision for their age Exclusion criteria: a score of 23/30 or less on the MMSE or not able to walk without support from another person |
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Interventions | 1. Group‐based Otago Exercise Programme: 45 minutes 2 a week for 12 weeks plus outdoor walking for 30 minutes, ≥ 3 a week for 12 weeks 2. Individual Otago Exercise Programme: 30 minutes, 3 a week for 12 weeks, plus outdoor walking for 30 minutes, ≥ 3 a week for 12 weeks Both groups received 4 home visits to check programme plus 4 telephone calls |
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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 of more falls requiring hospital admission 3. Health‐related quality of life 4. Number of people who died |
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Duration of the study | 12 weeks | |
Adherence | Adherence measured as session attendance 1. Group‐based Otago Exercise Programme: attended mean of 21.9 out of 24 sessions (SD 2.7) 2. Individual Otago Exercise Programme: attended mean 32.8 out of 36 recommended sessions (SD 2.8) |
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Notes | Source of funding: Norwegian Fund for Post‐Graduate Physiotherapy Training Economic information: not reported Email communication regarding fall data, response received, data not included in review |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A Web‐based block randomization procedure with varying group size, developed by the Applied Clinical Research Unit at the Norwegian University of Science and Technology, was used" |
Allocation concealment (selection bias) | Low risk | Centralised "web‐based" randomisation procedure |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel not blinded |
Blinding of outcome assessment (detection bias) Falls | High risk | Baseline to 3 months: fall calendars collected by unblinded exercise instructors at intervention sessions. 3 ‐ 6 months: falls collected retrospectively at 6‐month interview with blinded assessor |
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 | Method of ascertaining hospital admission is unclear |
Blinding of outcome assessment (detection bias) Health related quality of life (self report) | High risk | Participants not blinded to group allocaiton |
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 was not reported |
Method of ascertaining falls (recall bias) | High risk | Baseline to 3 months: falls were recorded on fall calendars which were collected by unblinded exercise instructors during twice‐weekly group sessions (intervention group) or at home visits in weeks 1, 2, 4 and 8 (control group). Non‐returns or incomplete calendars were followed up with the participant or next of kin; the person collecting this information unclear. 3 ‐ 6 months: falls collected retrospectively at 6‐month interview with blinded assessor |