2型糖尿病老年人的长期衰弱和身体机能转变。MIDFRAIL随机临床试验
Long-term frailty and physical performance transitions in older people with type-2 diabetes. The MIDFRAIL randomized clinical study.
作者信息
Laosa Olga, Topinkova Eva, Bourdel-Marchasson Isabelle, Vellas Bruno, Izquierdo Mikel, Paolisso Giusseppe, Hardman Timothy, Zeyfang Andrej, Pedraza Laura, Carnicero Jose A, Rodriguez-Mañas Leocadio, Sinclair Alan J
机构信息
Foundation for Biomedical Research-University Hospital of Getafe, Madrid, Spain; Biomedical Research Center Network for Frailty and Healthy Ageing (CIBERFES), Institute of Health Carlos III, Madrid, Spain.
First Faculty of Medicine, Charles University, Prague, Czech Republic.
出版信息
J Nutr Health Aging. 2025 Apr;29(4):100512. doi: 10.1016/j.jnha.2025.100512. Epub 2025 Feb 14.
AIMS
Type 2 diabetes (T2D) is associated with frailty in older people. We aim to explore changes in frailty status after ≥18 months of intervention.
METHODS
298 community-dwelling older adults (>70 years) participating in MIDFRAIL followed-up for 18-24 months were randomly allocated by trial site (cluster) to intervention IG (16-weeks resistance exercise program, nutritional-educational sessions, optimization of diabetes care), or usual care group (UCG). Frailty status was assessed by the Fried Frailty Phenotype criteria at baseline and final visit. Functional status was assessed by the SPPB in every visit. We used multivariate linear and logistic regression for continuous and dichotomous outcomes. This study was registered at Clinicaltrials.gov (NCT01654341).
RESULTS
Mean age was 77.7 (SD 5.54), 47% were male, 32.9% frail and 67.1% prefrail. The probability of improving the frailty status and decreasing the number of Fried's frailty criteria was higher in the IG than in the UCG (OR 2.6, 95%CI 1.3-5.4; p = 0.009 and OR 1.9; 95%CI 1.1-3.1; p = 0.02, respectively). IG participants more frequently improved ≥1 point in SPPB score (OR 1.85; 95%CI 1.09-3.12; p = 0.022). These benefits were mainly accounted for the prefrail participants.
CONCLUSIONS
The MIDFRAIL intervention improved frailty status and physical function at long-term follow-up in older people with T2D.
目的
2型糖尿病（T2D）与老年人的虚弱相关。我们旨在探讨干预≥18个月后虚弱状态的变化。
方法
298名参与MIDFRAIL研究的社区居住老年人（>70岁），随访18 - 24个月，按试验地点（聚类）随机分配至干预组（IG，16周抗阻运动计划、营养教育课程、糖尿病护理优化）或常规护理组（UCG）。在基线和末次访视时，采用Fried虚弱表型标准评估虚弱状态。每次访视时用简易体能状况量表（SPPB）评估功能状态。对于连续性和二分法结局，我们使用多变量线性和逻辑回归分析。本研究已在Clinicaltrials.gov注册（NCT01654341）。
结果
平均年龄为77.7岁（标准差5.54），47%为男性，32.9%为虚弱，67.1%为衰弱前期。与UCG相比，IG组改善虚弱状态和减少Fried虚弱标准数量的概率更高（优势比2.6，95%置信区间1.3 - 5.4；p = 0.009；优势比1.9；95%置信区间1.1 - 3.1；p = 0.02）。IG组参与者更频繁地在SPPB评分中提高≥1分（优势比1.85；95%置信区间1.09 - 3.12；p = 0.022）。这些益处主要体现在衰弱前期参与者中。
结论
MIDFRAIL干预在2型糖尿病老年人的长期随访中改善了虚弱状态和身体功能。
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