El-Khoury Fabienne, Cassou Bernard, Latouche Aurélien, Aegerter Philippe, Charles Marie-Aline, Dargent-Molina Patricia
Université Paris-Sud, UMR-S1018, F-94807, Villejuif, France Université Paris Descartes, UMR-S 1153, F-75014, Paris, France Inserm, Centre de Recherche Epidémiologie et Statistique Sorbonne Paris Cité (CRESS), U1153, F-94807, Villejuif, France.
UVSQ, UMR-S 1168, Université Versailles St-Quentin-en-Yvelines, France Inserm, VIMA: Vieillissement et Maladies Chroniques, U1168, F-94807, Villejuif, France AP-HP, Hôpital Sainte Périne, Centre de Gérontologie, F-75016, Paris, France.
BMJ. 2015 Jul 22;351:h3830. doi: 10.1136/bmj.h3830.
To assess the effectiveness of a two year exercise programme of progressive balance retraining in reducing injurious falls among women aged 75-85 at increased risk of falls and injuries and living in the community.
Pragmatic multicentre, two arm, parallel group, randomised controlled trial.
20 study sites in 16 medium to large cities throughout France.
706 women aged 75-85, 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).
Weekly supervised group sessions of progressive balance training offered in community based premises for two years, supplemented by individually prescribed home exercises.
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.
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 v 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 16-71). Five injurious falls related to the intervention were recorded.
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 75-85 at risk of falling.Trial registration ClinicalTrials.gov (NCT00545350).
评估一项为期两年的渐进性平衡再训练锻炼计划在降低社区中75 - 85岁、跌倒和受伤风险增加的女性的伤害性跌倒方面的有效性。
实用的多中心、双臂、平行组随机对照试验。
法国16个中大型城市的20个研究地点。
706名75 - 85岁、居住在自己家中、平衡和步态能力下降的女性,随机分配到实验干预组(锻炼计划,n = 352)或对照组(无干预,n = 354)。
在社区场所进行为期两年的每周一次的有监督的渐进性平衡训练小组课程,并辅以个性化规定的家庭锻炼。
一名对分组不知情的老年病医生根据身体损伤和医疗护理情况将跌倒分为三类(无后果、中度、重度)之一。主要观察指标是伤害性跌倒(中度和重度)的发生率。采用“共享脆弱性”模型比较两组伤害性跌倒的发生率。其他观察指标包括所有跌倒的发生率、身体功能能力(平衡和运动功能测试结果)、跌倒恐惧(FES - I)、身体活动水平以及感知的健康相关生活质量(SF - 36)。分析采用意向性分析。
干预组有305次伤害性跌倒,对照组有397次(风险比0.81,95%置信区间0.67至0.99)。重伤差异(干预组68次对对照组87次)处于相同数量级(0.83,0.60至1.16)。两年后,干预组女性在所有身体测试中的表现明显优于对照组女性,并且对其整体身体功能的感知也明显更好。在开始干预的女性(n = 294)中,参加小组课程的中位数为53次(四分位间距16 - 71)。记录到5次与干预相关的伤害性跌倒。
一项结合每周小组和个人课程的为期两年的渐进性平衡再训练计划在降低75 - 85岁有跌倒风险女性的伤害性跌倒以及改善测量和感知的身体功能方面是有效的。试验注册ClinicalTrials.gov(NCT00545350)。