Kovacs 2013.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months |
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Participants | Setting: Budapest, Hungary Number of participants: 76 Number analysed: 72 Number lost to follow‐up: 4 Sample: community‐dwelling women Age (years): Intervention mean 68.5 (SD 5.3), Control mean 68.3 (SD 6.4) Sex: 100% female Inclusion criteria: Women aged 60 years of age or over, lived in community setting Exclusion criteria: GP did not recommend their participation because of having progressive neurological or unstable cardiovascular diseases that would limit participation in the exercise programme, having severe pain in lower limb in weight‐bearing positions or participation in regular physical exercise programme (sport or physiotherapy) in the past 6 months |
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Interventions | 1. Group‐based balance and strength training plus home‐practice: exercises and competition games with no special equipment, 60‐minute sessions, 2 a week for 25 weeks 2. Control group: asked not to start any type of regular exercise programme and maintain their usual activities, offered participation in the next programme |
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Outcomes | 1. Rate of falls 2. Number of people who experienced 1 or more falls (risk of falling) |
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Duration of the study | 52 weeks | |
Adherence | Adherence measured as the percentage of the number of sessions completed out of the total 50 sessions 1. Group‐based balance and strength training plus home‐practice group: 81% (range 56 ‐ 100%) |
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Notes | Source of funding: Quality‐Metric Incorporated Economic information: not reported Email communication to obtain fall data, response received, data included in review |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Blocked randomisation was performed (with a block size of 4 and 6)". Insufficient information about the sequence generation process to permit judgement |
Allocation concealment (selection bias) | Low risk | Quote: "Consecutively numbered opaque identical sealed envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel unblinded but impact of unblinding unknown |
Blinding of outcome assessment (detection bias) Falls | Low risk | Fall calendars were distributed and collected by a physiotherapist who was not involved in the exercise programme and who was not informed about the participants’ group allocation. Blinding assumed |
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 | Less than 20% of fall outcome data are missing (5%). Missing data were balanced between the exercise (n = 2) and control (n = 2) groups |
Selective reporting (reporting bias) | Unclear risk | Minimum set of expected outcomes not reported, (adverse events not reported) |
Method of ascertaining falls (recall bias) | Low risk | Fall calendar, collected monthly |