Rehabilitation Research Group, Hospital del Mar Medical Research Institute, 08024 Barcelona, Catalonia, Spain.
Physical Medicine and Rehabilitation Department, National Institute of Physical Medicine and Rehabilitation, Panama City 0819, Panama.
Nutrients. 2024 Sep 10;16(18):3053. doi: 10.3390/nu16183053.
Resistance exercise and protein supplementation are recognized as effective treatment strategies for age-related sarcopenia; however, there are limited data on their feasibility, tolerability, and safety. The primary outcome of this study was feasibility, evaluated through the 15-item TELOS (Technological, Economics, Legal, Operational, and Scheduling) feasibility components and by recruitment, retention, and consent rates. Tolerability was measured by examining permanent treatment discontinuation, treatment interruption, exercise dose modification, early termination, rescheduling of missed sessions, losses to follow-up, attendance, and nutritional compliance. Safety was evaluated using the parameters provided by the European Medicines Agency, adapted for exercise interventions. Thirty-two subjects were recruited (average age 81.6 [SD 9.3] years). The TELOS components were assessed before the intervention; out of 15 questions relevant for successful implementation, 4 operational needs answers required specific actions to prevent potential barriers. The recruitment rate was 74%. Eleven patients (34.4%) had permanent treatment interruption (retention rate = 65.6%). Patients attended a mean of 23 (SD 12.0) exercise sessions, with a mean of 56 (SD 32.6) nutritional compliances. A total of 21 patients (65.6%) experienced adverse events unrelated to the intervention, while 7 patients (21.9%) presented adverse reactions to strength exercise. The main barriers to feasibility were operational components and recruitment challenges. Although the intervention was generally safe, the high rate of probable adverse effects, unrelated to the intervention but associated with the individual's baseline health condition, may affect adherence to treatment programs of this kind.
抗阻运动和蛋白质补充已被认为是治疗与年龄相关的肌肉减少症的有效策略;然而,关于其可行性、耐受性和安全性的数据有限。本研究的主要结局是可行性,通过 15 项 TELOS(技术、经济、法律、运营和调度)可行性组成部分以及招募、保留和同意率进行评估。耐受性通过检查永久性治疗中断、治疗中断、运动剂量调整、提前终止、错过的治疗方案重新安排、随访丢失、出勤率和营养依从性来衡量。安全性使用欧洲药品管理局提供的参数进行评估,适用于运动干预。共招募了 32 名受试者(平均年龄 81.6 [9.3]岁)。在干预前评估了 TELOS 成分;在 15 个与成功实施相关的问题中,有 4 个运营需求答案需要采取具体行动来预防潜在的障碍。招募率为 74%。11 名患者(34.4%)永久性中断治疗(保留率=65.6%)。患者平均参加 23 次(SD 12.0)运动课程,平均接受 56 次(SD 32.6)营养依从性治疗。共有 21 名患者(65.6%)出现与干预无关的不良事件,而 7 名患者(21.9%)出现与力量训练相关的不良反应。可行性的主要障碍是运营组件和招募挑战。尽管该干预总体上是安全的,但高比例的可能不良影响与干预无关,但与个体的基线健康状况有关,可能会影响此类治疗方案的依从性。