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][1]. Anonymised raw trial data can be shared on request to Luca Mariotti (luca.mariotti1@unicatt.it). A data access agreement needs to be signed. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02582138&atom=%2Fbmj%2F377%2Fbmj-2021-068788.atom

中文翻译：

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预防体弱老年人行动障碍的多组分干预：随机对照试验（SPRINTT 项目）

目的 确定基于身体活动以及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肉减少症的老年人的行动障碍。设计评估员设盲、随机对照试验。2016 年 1 月至 2019 年 10 月 31 日，在 11 个欧洲国家/地区设置 16 个临床地点。参与者为 1519 名 70 岁或以上患有身体虚弱和肌肉减少症的社区男性和女性，作为低功能状态的共同发生进行操作，定义为短身体性能电池 (SPPB) 评分为 3 至 9，四肢瘦体重低，能够独立行走 400 米。760 名参与者被随机分配到多组分干预组，759 名参与者接受了健康老龄化教育（对照组）。干预措施 多组分干预措施包括每周两次在中心进行的中等强度身体活动以及每周最多四次在家进行的活动。活动测量数据用于调整干预措施。参与者还接受了个性化的营养咨询。对照组参与者每月接受一次健康老龄化教育。干预和随访持续长达 36 个月。主要结果指标 主要结果是行动障碍（无法在 <15 分钟内独立行走 400 米）。持续行动不便（无法连续两次步行 400 米）以及从基线到 24 个月和 36 个月的身体表现、肌肉力量和四肢瘦体重的变化作为预先计划的次要结果进行分析。主要比较是在基线 SPPB 分数为 3-7 (n=1205) 的参与者中进行的。SPPB 得分为 8 或 9 的患者 (n=314) 被单独分析以用于探索目的。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 (SD 9.5) 个月。在 SPPB 评分为 3-7 的参与者中，分配给多组分干预的参与者中有 283/605 (46.8%) 人发生行动障碍，而对照组有 316/600 (52.7%) 人（风险比为 0.78，95% 置信区间为 0.67 至 0.92；P= 0.005）。分配给多组分干预的 127/605 (21.0%) 参与者和 150/600 (25.0%) 对照组发生持续性行动障碍（0.79，0.62 至 1.01；P=0.06）。SPPB 评分的组间差异为 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）分别在 24 个月和 36 个月时支持多组分干预。被分配到多组分干预组的女性在 24 个月时的握力下降幅度小于对照组（0.9 公斤，95% 置信区间为 0.1 至 1.6 公斤；P=0.028）。在 24 个月（95% 置信区间 0.10 至 0.39 公斤；P<0.001）和 36 个月（0.26 至 0.73 公斤；P<0.001）时，多组分干预组的女性比对照组少了 0.24 公斤和 0.49 公斤. 严重不良事件发生在分配给多组分干预的 237/605 (39.2%) 参与者和 216/600 (36.0%) 对照组中（风险比 1.09，95% 置信区间 0.94 至 1.26）。在 SPPB 得分为 8 或 9 的参与者中，46/155 (29. 7%）在多组分干预和 38/159（23.9%）对照中（风险比 1.25，95% 置信区间 0.79 至 1.95；P=0.34）。结论 多因素干预与身体虚弱和肌肉减少症且 SPPB 评分为 3-7 的老年人行动障碍的发生率降低有关。可能针对身体虚弱和肌肉减少症，以保持弱势老年人的活动能力。试验注册 ClinicalTrials.gov [NCT02582138][1]。匿名原始试验数据可应要求与 Luca Mariotti (luca.mariotti1@unicatt.it) 共享。需要签署数据访问协议。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02582138&atom=%2Fbmj%2F377%2Fbmj-2021-068788.atom 结论 多因素干预与身体虚弱和肌肉减少症且 SPPB 评分为 3-7 的老年人行动障碍的发生率降低有关。可能针对身体虚弱和肌肉减少症，以保持弱势老年人的活动能力。试验注册 ClinicalTrials.gov [NCT02582138][1]。匿名原始试验数据可应要求与 Luca Mariotti (luca.mariotti1@unicatt.it) 共享。需要签署数据访问协议。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02582138&atom=%2Fbmj%2F377%2Fbmj-2021-068788.atom 结论 多因素干预与身体虚弱和肌肉减少症且 SPPB 评分为 3-7 的老年人行动障碍的发生率降低有关。可能针对身体虚弱和肌肉减少症，以保持弱势老年人的活动能力。试验注册 ClinicalTrials.gov [NCT02582138][1]。匿名原始试验数据可应要求与 Luca Mariotti (luca.mariotti1@unicatt.it) 共享。需要签署数据访问协议。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02582138&atom=%2Fbmj%2F377%2Fbmj-2021-068788.atom 可能针对身体虚弱和肌肉减少症，以保持弱势老年人的活动能力。试验注册 ClinicalTrials.gov [NCT02582138][1]。匿名原始试验数据可应要求与 Luca Mariotti (luca.mariotti1@unicatt.it) 共享。需要签署数据访问协议。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02582138&atom=%2Fbmj%2F377%2Fbmj-2021-068788.atom 可能针对身体虚弱和肌肉减少症，以保持弱势老年人的活动能力。试验注册 ClinicalTrials.gov [NCT02582138][1]。匿名原始试验数据可应要求与 Luca Mariotti (luca.mariotti1@unicatt.it) 共享。需要签署数据访问协议。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02582138&atom=%2Fbmj%2F377%2Fbmj-2021-068788.atom