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Effectiveness of two year balance training programme on prevention of fall induced injuries in at risk women aged 75 to 85 living in community: Ossebo randomised controlled trial [with consumer summary] |
el-Khoury F, Cassou B, Latouche A, Aegerter P, Charles M-A, Dargent-Molina P |
BMJ 2015 Jul 22;351:h3830 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To assess the effectiveness of a two year exercise programme of progressive balance retraining in reducing injurious falls among women aged 75 to 85 at increased risk of falls and injuries and living in the community. DESIGN: Pragmatic multicentre, two arm, parallel group, randomised controlled trial. SETTING: 20 study sites in 16 medium to large cities throughout France. PARTICIPANTS: 706 women aged 75 to 85, living in their own home, and with diminished balance and gait capacities, randomly allocated to the experimental intervention group (exercise programme, n = 352) or the control group (no intervention, n = 354). INTERVENTION: Weekly supervised group sessions of progressive balance training offered in community based premises for two years, supplemented by individually prescribed home exercises. OUTCOME MEASURES: A geriatrician blinded to group assignment classified falls into one of three categories (no consequence, moderate, severe) based on physical damage and medical care. The primary outcome was the rate of injurious falls (moderate and severe). The two groups were compared for rates of injurious falls with a "shared frailty" model. Other outcomes included the rates of all falls, physical functional capacities (balance and motor function test results), fear of falling (FES-I), physical activity level, and perceived health related quality of life (SF-36). Analysis was by intention to treat. RESULTS: There were 305 injurious falls in the intervention group and 397 in the control group (hazard ratio 0.81, 95% confidence interval 0.67 to 0.99). The difference in severe injuries (68 in intervention group versus 87 in control group) was of the same order of magnitude (0.83, 0.60 to 1.16). At two years, women in the intervention group performed significantly better on all physical tests and had significantly better perception of their overall physical function than women in the control group. Among women who started the intervention (n = 294), the median number of group sessions attended was 53 (interquartile range 16 to 71). Five injurious falls related to the intervention were recorded. CONCLUSION: A two year progressive balance retraining programme combining weekly group and individual sessions was effective in reducing injurious falls and in improving measured and perceived physical function in women aged 75 to 85 at risk of falling. TRIAL REGISTRATION: ClinicalTrials.gov (NCT00545350).
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