Fielding Roger A, Rolland Yves, Bruyere Olivier, Desvarieux Moise, Donini Lorenzo M, Incalzi Raffaele Antonelli, Muscaritoli Maurizio, Tchalla Achille, Bonnefoy Marc, Rondanelli Mariangela, Van Maanen Rob, Mariani Jean, Margalef Carole, Del Signore Susanna, Tourette Cendrine, Dioh Waly, Veillet Stanislas
Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington St, Boston, MA, 02111, USA.
IHU HealthAge, Centre Hospitalo-Universitaire de Toulouse, CERPOP UMR 1295, University of Toulouse III, Toulouse, France.
BMC Geriatr. 2025 Aug 4;25(1):590. doi: 10.1186/s12877-025-05895-9.
Aging is associated with a progressive change of body composition characterized by muscle mass decline and accumulation of adipose tissue that can lead to sarcopenia and obesity, respectively. The prevalence of sarcopenia is poorly known given the different parameters and thresholds in proposed definitions. The combination of obesity (defined as a percentage of body fat mass of > 25% in men and > 35% in women) and sarcopenia (SO) adds complexity to the characterization of this pathology. SARA-OBS aimed to better characterize sarcopenia (including SO) and its consequences on physical function over time, in community-dwelling older adults at risk of mobility disability, and to support the design of further interventional clinical trials.
This was an international, multicenter, 6-month observational study of men and women aged ≥ 65 years suffering from sarcopenia according to the Foundation for the National Institute of Health (FNIH) cut-offs for Sarcopenia and with a Short Physical Performance Battery (SPPB) ≤ 8. The primary endpoint was the change in Gait Speed (GS) in the 400-meter walking test (400MWT), reported at baseline and at Month 6/ end of the study (EOS). Secondary endpoints included changes in handgrip strength (HGS), physical performance (6-Minute Walking Distance [6MWD], SPPB), the Physical Function Domain (PF-10) sub-score and total score of the SF-36 survey and the Sarcopenia and Quality of Life (SarQoL) questionnaire.
Overall, the mean (± SD) change from baseline to Month 6/EOS in 400MWT GS was - 0.027 ± 0.171 m/sec (p = 0.064). Both GS and 6MWD decreased significantly in subgroup with GS ≥ 0.8 m/sec at baseline (-0.047 ± 0.185 m/sec; p = 0.017 and - 24.01 ± 68.24 m; p = 0.001, respectively). In subgroup with SPPB = 8 at baseline, 6MWD also decreased (-36.80 ± 67.60 m; p < 0.001). We observed a significant change from baseline for 6MWD in the SO subgroup (-18.30 ± 81.95 m; p = 0.013). Neither HGS nor SarQoL changed significantly from baseline to Month 6/EOS.
SARA-OBS results contribute to defining subgroups of older adults at risk of functional decline over 6 months, specifically subjects with SPPB = 8, affecting GS and the 6MWD. Additionally, the SO subpopulation exhibited a relevant deterioration in physical function as evaluated by the 6MWD.
NCT03021798 (ClinicalTrials.gov). Date of registration 16/01/2017.
衰老与身体组成的渐进性变化相关，其特征是肌肉量减少和脂肪组织堆积，分别可导致肌肉减少症和肥胖症。鉴于提议定义中的不同参数和阈值，肌肉减少症的患病率鲜为人知。肥胖（定义为男性体脂质量百分比>25%，女性>35%）与肌肉减少症（SO）的合并增加了这种病理特征的复杂性。SARA - OBS旨在更好地表征肌肉减少症（包括SO）及其对有行动能力残疾风险的社区居住老年人随时间推移的身体功能的影响，并支持进一步干预性临床试验的设计。
这是一项针对年龄≥65岁、根据美国国立卫生研究院基金会（FNIH）肌肉减少症标准被诊断为患有肌肉减少症且短身体性能测试（SPPB）≤8的男性和女性进行的国际多中心6个月观察性研究。主要终点是在400米步行测试（400MWT）中基线和第6个月/研究结束时（EOS）报告的步态速度（GS）变化。次要终点包括握力（HGS）变化、身体性能（6分钟步行距离[6MWD]、SPPB）、SF - 36调查问卷的身体功能领域（PF - 10）子评分和总分以及肌肉减少症与生活质量（SarQoL）问卷。
总体而言，从基线到第6个月/EOS，400MWT的GS平均（±标准差）变化为 - 0.027±0.171米/秒（p = 0.064）。在基线时GS≥0.8米/秒的亚组中，GS和6MWD均显著下降（分别为 - 0.047±0.185米/秒；p = 0.017和 - 24.01±68.24米；p = 0.001）。在基线时SPPB = 8的亚组中，6MWD也下降了（ - 36.80±67.60米；p < 0.001）。我们观察到SO亚组的6MWD相对于基线有显著变化（ - 18.30±81.95米；p = 0.013）。从基线到第6个月/EOS，HGS和SarQoL均无显著变化。
SARA - OBS的结果有助于确定在6个月内有功能下降风险的老年人亚组，特别是SPPB = 8的受试者，其影响GS和6MWD。此外，通过6MWD评估，SO亚组的身体功能出现了明显恶化。
NCT03021798（ClinicalTrials.gov）。注册日期2017年1月16日。
