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MOVI 衰老随机对照试验方案:一项基于家庭的认知挑战性电子健康干预,旨在提高老年人的心肺健康和认知功能。

Protocol of the MOVI-ageing randomized controlled trial: a home-based e-Health intervention of cognitively demanding exercise for the improvement of cardiorespiratory fitness and cognitive function in older individuals.

机构信息

Health and Social Research Center, Universidad de Castilla-La Mancha, Cuenca, Spain.

Universidad Politécnica y Artística del Paraguay, Asunción, Paraguay.

出版信息

Front Public Health. 2023 Dec 22;11:1298316. doi: 10.3389/fpubh.2023.1298316. eCollection 2023.

Abstract

OBJECTIVE

To describe the protocol of the MOVI-ageing randomized controlled trial, a home-based eHealth intervention of cognitive-demanding exercise for older adults, in improving global cognitive function and basic cognitive functions, cardiorespiratory fitness, and muscle fitness.

METHODS

This randomized controlled trial will include participants identified in the social centers of Cuenca and Talavera de la Reina who agree to participate and provide informed consent. Adults aged 60-80 years of both genders retired regardless of the reason for retirement, who do not meet frailty criteria according to Fried criteria, and without cognitive impairment will be invited to participate. This study will be developed in two phases: (i) a 12-week randomized efficacy/feasibility trial and (ii) a large-scale implementation randomized trial phase with a 12-week follow-up following similar procedures. In addition, a qualitative study on barriers to and facilitators of the implementation of the physical exercise intervention using eHealth for older people will be conducted. Participants will have access to a platform including videos of cognitively demanding physical exercise. The participants will be remotely and off-line guided through the physical exercise intervention, and the research team will be able to check the degree of compliance with the program and its correct execution. The participants will receive feedback on their compliance with the routines and reinforcement messages.

IMPLICATIONS

The implementations of the findings and their inclusion in guidelines may directly impact in older people's life, and relatives, through the prevention of morbidity and the reduction of years lost to disability. These benefits may be reflected in the reduction of economic expenditure by reducing the demand for social and health care services.

ETHICS

The Clinical Research Ethics Committee of the 'Virgen de la Luz' Hospital in Cuenca approved the study protocol (registration number: 2022/PI3222). In addition, this protocol was previously registered in Clinicaltrials.gov (Number: NCT05928078).

摘要

目的

描述 MOVI-ageing 随机对照试验的方案,这是一项针对老年人的基于家庭的认知需求型电子健康干预,旨在改善整体认知功能和基本认知功能、心肺健康和肌肉健康。

方法

这项随机对照试验将包括在昆卡和塔拉维拉德拉雷纳的社会中心确定的参与者,他们同意参与并提供知情同意。邀请年龄在 60-80 岁之间、无论退休原因如何的两性成年人退休人员参与,这些人不符合根据 Fried 标准确定的虚弱标准,并且没有认知障碍。这项研究将分为两个阶段进行:(i)为期 12 周的随机有效性/可行性试验,以及(ii)具有类似程序的为期 12 周随访的大规模实施随机试验阶段。此外,还将开展一项关于使用电子健康为老年人实施体能锻炼干预的障碍和促进因素的定性研究。参与者将可以访问一个包含认知需求型体能锻炼视频的平台。研究团队将远程和离线指导他们进行体能锻炼干预,同时能够检查他们对方案的遵守程度和正确执行情况。参与者将收到关于其遵守日常锻炼和收到强化信息的反馈。

意义

实施研究结果并将其纳入指南可能会直接影响老年人及其亲属的生活,通过预防发病和减少因残疾而丧失的年限。这些好处可能会反映在减少对社会和医疗保健服务的需求方面,从而减少经济支出。

伦理

昆卡的“Virgen de la Luz”医院临床研究伦理委员会批准了研究方案(注册号:2022/PI3222)。此外,该方案先前在 ClinicalTrials.gov 注册(编号:NCT05928078)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a9b/10771291/bb04938ed208/fpubh-11-1298316-g001.jpg

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