Physical Education School, Universidade Federal de Pelotas, Pelotas, RS, Brazil.
School of Physical Education, Physical Therapy and Dance, Universidade Federal Do Rio Grande Do Sul, Porto Alegre, RS, Brazil.
Trials. 2023 Aug 21;24(1):547. doi: 10.1186/s13063-023-07567-8.
Despite the robust body of evidence for the benefits of home-based physical exercise, there is still a paucity of data on the benefits of home-based cognitive training for older adults, especially in those at increased risk of clinical-functional vulnerability. As such, the present study aims to compare the chronic effects of a telehealth-delivered physical training intervention alone or combined with a cognitive training program in older adults at increased clinical-functional vulnerability risk.
A randomized clinical trial will be conducted including 62 sedentary older individuals classified as at increased risk of clinical-functional vulnerability based on their Clinical-Functional Vulnerability Index score. Participants will be randomly allocated in a 1:1 ratio to one of two groups, an intervention group including physical training combined with cognitive training, or an active control group including physical training alone. Both groups will receive home-based supervised training remotely for 12 weeks and will be assessed for the primary and secondary outcomes of the study before and after the training period. Primary outcomes include cognitive function and dynamic balance with a dual task. Secondary outcomes encompass physical, cognitive, and occupational performance, functional capacity, quality of life, and anxiety and depression symptoms, as well as hemodynamic measures. Data analysis will be performed by intention-to-treat and per protocol using mixed linear models and Bonferroni's post hoc (α = 0.05).
Our conceptual hypothesis is that both groups will show improvements in the primary and secondary outcomes. Nevertheless, we expect physical combined with cognitive training to improve cognitive function, dual task, and occupational performance to a greater degree as compared to physical training alone.
NCT05309278. Registered on April 4, 2022.
尽管有大量证据表明家庭为基础的体育锻炼对老年人有益，但关于家庭为基础的认知训练对老年人的益处的数据仍然很少，尤其是对于那些处于临床功能脆弱风险增加的老年人。因此，本研究旨在比较远程医疗提供的单纯体力训练干预与结合认知训练方案对处于临床功能脆弱风险增加的老年人的慢性影响。
将进行一项随机临床试验，纳入 62 名久坐不动的老年人，根据其临床功能脆弱指数评分，他们被归类为具有临床功能脆弱风险增加。参与者将以 1:1 的比例随机分配到两个组之一，一个干预组包括体力训练与认知训练相结合，另一个对照组包括单纯体力训练。两组都将接受为期 12 周的家庭监督远程训练，并在训练前后评估研究的主要和次要结果。主要结果包括认知功能和双重任务的动态平衡。次要结果包括身体、认知和职业表现、功能能力、生活质量、焦虑和抑郁症状以及血液动力学指标。数据分析将通过意向治疗和按方案进行，使用混合线性模型和 Bonferroni 的事后检验（α=0.05）。
我们的概念假设是两组都将在主要和次要结果上显示出改善。然而，我们预计体力训练与认知训练相结合将比单纯体力训练更能改善认知功能、双重任务和职业表现。
NCT05309278。于 2022 年 4 月 4 日注册。
