Beyer 2007.
Methods | Study design: RCT Number of study arms: 2 Length of follow‐up: 12 months | |
Participants | Setting: Copenhagen, Denmark Number of participants: 65 Number analysed: 53 Number lost to follow‐up: 12 Sample: women with a history of a fall identified from hospital records Age (years): range 70 ‐ 90 Sex: 100% female Inclusion criteria: community‐dwelling; at a relatively high risk of falls, defined as either ≥ 80 years old or ≥ 65 years with history of a fall in the previous 12 months or a timed 'up and go' test score of at least 15 seconds; home‐dwelling; aged 70 ‐ 90 years; history of a fall requiring treatment in ED but not hospitalisation; able to come to training facility Exclusion criteria: lower limb fracture in last 6 months; neurological diseases, unable to understand Danish; cognitively impaired (MMSE < 24) |
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Interventions | 1. Group‐based balance, strength and flexibility training: gym equipment used for strengthening, 1 hour, 2 a week, for 6 months 2. Control: no intervention; offered intervention after 1 year | |
Outcomes | 1. Number of people who experienced 1 or more falls (risk of falling) | |
Duration of the study | 52 weeks | |
Adherence | Adherence measured by training compliance 1. Group‐based balance, strength and flexibility training group: mean training compliance 79% (42 ‐ 100%) |
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Notes | Source of funding: Danish Medical Association Research Fund, Danish Medical Research Council
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: "…using the minimization method with the aid of a computer program for randomization" |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel not blinded to allocated group but impact of non‐blinding unclear |
Blinding of outcome assessment (detection bias) Falls | Unclear risk | Falls were recorded in both allocated groups using the same method (a monthly falls calendar), but no mention of blinding of personnel confirming falls or carrying out data entry. Insufficient information to make a judgement |
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 | Unclear risk | Less than 20% of outcome data are missing (18%). Unbalanced losses in intervention (n = 10) and control (n = 4) groups, with reasons for missing fall data differing between the 2 groups (intervention group: n = 3 did not start training, 4 = ill, 1 = fracture, 2 = lost to follow‐up; control group: n = 1 dropped out as unhappy with group allocation, 1 = ill, 1 = fracture, 1 = spouse ill) |
Selective reporting (reporting bias) | High risk | The study prespecified falls "were monitored in all participants during the study period", but number of falls was not reported |
Method of ascertaining falls (recall bias) | Low risk | Quote: "A falls calendar was sent to every participant on the first day of each month" for 1 year |