Gill Thomas M, Pahor Marco, Guralnik Jack M, McDermott Mary M, King Abby C, Buford Thomas W, Strotmeyer Elsa S, Nelson Miriam E, Sink Kaycee M, Demons Jamehl L, Kashaf Susan S, Walkup Michael P, Miller Michael E
Department of Medicine, Yale School of Medicine, Adler Geriatric Center, 874 Howard Avenue, New Haven, CT 06510, USA
Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.
BMJ. 2016 Feb 3;352:i245. doi: 10.1136/bmj.i245.
To test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations.
Multicenter, single blinded randomized trial (Lifestyle Interventions and Independence for Elders (LIFE) study).
Eight centers across the United States, February 2010 to December 2011.
1635 sedentary adults aged 70-89 years with functional limitations, defined as a short physical performance battery score ≤ 9, but who were able to walk 400 m.
A permuted block algorithm stratified by field center and sex was used to allocate interventions. Participants were randomized to a structured, moderate intensity physical activity program (n=818) conducted in a center (twice a week) and at home (3-4 times a week) that included aerobic, strength, flexibility, and balance training activities, or to a health education program (n=817) consisting of workshops on topics relevant to older people and upper extremity stretching exercises.
Serious fall injuries, defined as a fall that resulted in a clinical, non-vertebral fracture or that led to a hospital admission for another serious injury, was a prespecified secondary outcome in the LIFE Study. Outcomes were assessed every six months for up to 42 months by staff masked to intervention assignment. All participants were included in the analysis.
Over a median follow-up of 2.6 years, a serious fall injury was experienced by 75 (9.2%) participants in the physical activity group and 84 (10.3%) in the health education group (hazard ratio 0.90, 95% confidence interval 0.66 to 1.23; P=0.52). These results were consistent across several subgroups, including sex. However, in analyses that were not prespecified, sex specific differences were observed for rates of all serious fall injuries (rate ratio 0.54, 95% confidence interval 0.31 to 0.95 in men; 1.07, 0.75 to 1.53 in women; P=0.043 for interaction), fall related fractures (0.47, 0.25 to 0.86 in men; 1.12, 0.77 to 1.64 in women; P=0.017 for interaction), and fall related hospital admissions (0.41, 0.19 to 0.89 in men; 1.10, 0.65 to 1.88 in women; P=0.039 for interaction).
In this trial, which was underpowered to detect small, but possibly important reductions in serious fall injuries, a structured physical activity program compared with a health education program did not reduce the risk of serious fall injuries among sedentary older people with functional limitations. These null results were accompanied by suggestive evidence that the physical activity program may reduce the rate of fall related fractures and hospital admissions in men.Trial registration ClinicalsTrials.gov NCT01072500.
比较长期结构化体育活动计划与健康教育计划，是否能降低功能受限的久坐老年人群严重跌倒受伤的风险。
多中心、单盲随机试验（老年人生活方式干预与独立性（LIFE）研究）。
2010年2月至2011年12月期间，美国的八个中心。
1635名70 - 89岁的久坐成年人群，功能受限定义为简短体能测试得分≤9，但能够行走400米。
采用按现场中心和性别分层的置换区组算法分配干预措施。参与者被随机分为结构化中等强度体育活动计划组（n = 818），该计划在中心（每周两次）和家中（每周3 - 4次）进行，包括有氧运动、力量训练、柔韧性训练和平衡训练活动；或健康教育计划组（n = 817），包括与老年人相关主题的研讨会以及上肢伸展运动。
严重跌倒受伤定义为导致临床非椎体骨折或因其他严重损伤而住院的跌倒，是LIFE研究预先设定的次要结局指标。由对干预分配不知情的工作人员每六个月评估一次结局，最长评估42个月。所有参与者均纳入分析。
在中位随访2.6年期间，体育活动组75名（9.2%）参与者发生严重跌倒受伤，健康教育组84名（10.3%）（风险比0.90，95%置信区间0.66至1.23；P = 0.52）。这些结果在包括性别在内的几个亚组中是一致的。然而，在未预先设定的分析中，观察到所有严重跌倒受伤发生率存在性别差异（男性率比0.54，95%置信区间0.31至0.95；女性1.07，0.75至1.53；交互作用P = 0.043）、跌倒相关骨折（男性0.47，0.25至0.86；女性1.12，0.77至1.64；交互作用P = 0.017）以及跌倒相关住院（男性0.41，0.19至0.89；女性1.10，0.65至1.88；交互作用P = 0.039）。
在本试验中，由于检测严重跌倒受伤方面可能存在的虽小但可能重要的降低效果的效能不足，与健康教育计划相比，结构化体育活动计划并未降低功能受限的久坐老年人群严重跌倒受伤的风险。这些阴性结果伴随着提示性证据，即体育活动计划可能降低男性跌倒相关骨折和住院的发生率。试验注册ClinicalsTrials.gov NCT01072500 。
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