Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Rome, Italy.
Department of Geriatrics and Orthopaedics, Università Cattolica del Sacro Cuore, Rome, Italy.
BMJ. 2022 May 11;377:e068788. doi: 10.1136/bmj-2021-068788.
OBJECTIVE: To determine whether a multicomponent intervention based on physical activity with technological support and nutritional counselling prevents mobility disability in older adults with physical frailty and sarcopenia. DESIGN: Evaluator blinded, randomised controlled trial. SETTING: 16 clinical sites across 11 European countries, January 2016 to 31 October 2019. PARTICIPANTS: 1519 community dwelling men and women aged 70 years or older with physical frailty and sarcopenia, operationalised as the co-occurrence of low functional status, defined as a short physical performance battery (SPPB) score of 3 to 9, low appendicular lean mass, and ability to independently walk 400 m. 760 participants were randomised to a multicomponent intervention and 759 received education on healthy ageing (controls). INTERVENTIONS: The multicomponent intervention comprised moderate intensity physical activity twice weekly at a centre and up to four times weekly at home. Actimetry data were used to tailor the intervention. Participants also received personalised nutritional counselling. Control participants received education on healthy ageing once a month. Interventions and follow-up lasted for up to 36 months. MAIN OUTCOME MEASURES: The primary outcome was mobility disability (inability to independently walk 400 m in <15 minutes). Persistent mobility disability (inability to walk 400 m on two consecutive occasions) and changes from baseline to 24 and 36 months in physical performance, muscle strength, and appendicular lean mass were analysed as pre-planned secondary outcomes. Primary comparisons were conducted in participants with baseline SPPB scores of 3-7 (n=1205). Those with SPPB scores of 8 or 9 (n=314) were analysed separately for exploratory purposes. RESULTS: Mean age of the 1519 participants (1088 women) was 78.9 (standard deviation 5.8) years. The average follow-up was 26.4 (SD 9.5) months. Among participants with SPPB scores of 3-7, mobility disability occurred in 283/605 (46.8%) assigned to the multicomponent intervention and 316/600 (52.7%) controls (hazard ratio 0.78, 95% confidence interval 0.67 to 0.92; P=0.005). Persistent mobility disability occurred in 127/605 (21.0%) participants assigned to the multicomponent intervention and 150/600 (25.0%) controls (0.79, 0.62 to 1.01; P=0.06). The between group difference in SPPB score was 0.8 points (95% confidence interval 0.5 to 1.1 points; P<0.001) and 1.0 point (95% confidence interval 0.5 to 1.6 points; P<0.001) in favour of the multicomponent intervention at 24 and 36 months, respectively. The decline in handgrip strength at 24 months was smaller in women assigned to the multicomponent intervention than to control (0.9 kg, 95% confidence interval 0.1 to 1.6 kg; P=0.028). Women in the multicomponent intervention arm lost 0.24 kg and 0.49 kg less appendicular lean mass than controls at 24 months (95% confidence interval 0.10 to 0.39 kg; P<0.001) and 36 months (0.26 to 0.73 kg; P<0.001), respectively. Serious adverse events occurred in 237/605 (39.2%) participants assigned to the multicomponent intervention and 216/600 (36.0%) controls (risk ratio 1.09, 95% confidence interval 0.94 to 1.26). In participants with SPPB scores of 8 or 9, mobility disability occurred in 46/155 (29.7%) in the multicomponent intervention and 38/159 (23.9%) controls (hazard ratio 1.25, 95% confidence interval 0.79 to 1.95; P=0.34). CONCLUSIONS: A multicomponent intervention was associated with a reduction in the incidence of mobility disability in older adults with physical frailty and sarcopenia and SPPB scores of 3-7. Physical frailty and sarcopenia may be targeted to preserve mobility in vulnerable older people. TRIAL REGISTRATION: ClinicalTrials.gov NCT02582138.
目的:确定基于体力活动并辅以技术支持和营养咨询的多组分干预是否可以预防身体虚弱和肌少症的老年人发生移动障碍。
设计:评估人员设盲、随机对照试验。
地点:16 个临床地点分布在 11 个欧洲国家,2016 年 1 月至 2019 年 10 月 31 日。
参与者:1519 名 70 岁或以上、身体虚弱且患有肌少症的社区居住的男性和女性,身体虚弱和肌少症的定义为短体适能表现测试(SPPB)评分 3 至 9 分、四肢瘦体重低以及能够独立行走 400 米的情况同时出现。760 名参与者被随机分配到多组分干预组,759 名参与者接受健康老龄化教育(对照组)。
干预措施:多组分干预包括每周两次在中心进行中等强度的体力活动,以及在家中每周最多进行四次。使用活动数据来定制干预措施。参与者还接受个性化的营养咨询。对照组参与者每月接受一次健康老龄化教育。干预和随访时间最长为 36 个月。
主要结局指标:主要结局是移动障碍(无法在 15 分钟内独立行走 400 米)。持续性移动障碍(无法连续两次行走 400 米)以及 24 个月和 36 个月时身体表现、肌肉力量和四肢瘦体重的变化是作为预先计划的次要结局进行分析的。主要比较是在基线 SPPB 评分为 3-7(n=1205)的参与者中进行的。对于 SPPB 评分为 8 或 9(n=314)的参与者,单独进行了探索性分析。
结果:1519 名参与者(1088 名女性)的平均年龄为 78.9(标准差 5.8)岁。平均随访时间为 26.4(标准差 9.5)个月。在 SPPB 评分为 3-7 的参与者中,移动障碍发生在多组分干预组的 605 名(46.8%)参与者中和对照组的 600 名(52.7%)参与者中(危险比 0.78,95%置信区间 0.67 至 0.92;P=0.005)。持续性移动障碍发生在多组分干预组的 605 名(21.0%)参与者中和对照组的 600 名(25.0%)参与者中(0.79,0.62 至 1.01;P=0.06)。24 个月和 36 个月时,多组分干预组的 SPPB 评分分别提高了 0.8 分(95%置信区间 0.5 至 1.1 分;P<0.001)和 1.0 分(95%置信区间 0.5 至 1.6 分;P<0.001)。24 个月时,女性参与者中,多组分干预组的握力下降幅度小于对照组(0.9 千克,95%置信区间 0.1 至 1.6 千克;P=0.028)。多组分干预组的女性参与者在 24 个月和 36 个月时的四肢瘦体重分别比对照组少 0.24 千克和 0.49 千克(95%置信区间 0.10 至 0.39 千克;P<0.001)和 0.26 千克至 0.73 千克(P<0.001)。多组分干预组的 605 名参与者(39.2%)和对照组的 600 名参与者(36.0%)发生了严重不良事件(风险比 1.09,95%置信区间 0.94 至 1.26)。在 SPPB 评分为 8 或 9 的参与者中,移动障碍发生在多组分干预组的 155 名(29.7%)参与者中和对照组的 159 名(23.9%)参与者中(危险比 1.25,95%置信区间 0.79 至 1.95;P=0.34)。
结论:多组分干预可降低身体虚弱和肌少症且 SPPB 评分为 3-7 的老年人发生移动障碍的发生率。身体虚弱和肌少症可能是针对易受伤害的老年人保持移动能力的靶点。
试验注册:ClinicalTrials.gov NCT02582138。
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