School of Nursing, Tung Wah College, Hong Kong SAR, China.
School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR, China.
Trials. 2023 May 17;24(1):339. doi: 10.1186/s13063-023-07335-8.
BACKGROUND: Cognitive frailty is a risk for many adverse health outcomes that are commonly observed in older people. Physical activity is known to be effective to reserve cognitive frailty but the prevalence of physical inactivity is still high in older people. E-health enhances behavioural change effects through an innovative way to deliver behavioural change methods that can enhance the behavioural change effects. However, its effects on older people with cognitive frailty, its effects compared with conventional behavioural change methods, and the sustainability of the effects are unclear. METHODS: This study employs a single-blinded, two-parallel-group, non-inferiority, randomized controlled trial design with a 1:1 group allocation ratio. Eligible participants are aged 60 years or above, have cognitive frailty and physical inactivity, and possess a smartphone for more than six months. The study will be conducted in community settings. In the intervention group, participants will receive a 2-week brisk-walking training followed by a 12-week e-health intervention. In the control group, participants will receive a 2-week brisk-walking training followed by a 12-week conventional behavioural change intervention. The primary outcome is minutes of moderate-to-vigorous physical activity (MVPA). This study aims to recruit a total of 184 participants. Generalized estimating equations (GEE) will be used to examine the effects of the intervention. ETHICS AND DISSEMINATION: The trial has been registered at ClinicalTrials.gov (Identifier: NCT05758740) on 7th March 2023, https://clinicaltrials.gov/ct2/show/NCT05758740 , and all items come from the World Health Organization Trial Registration Data Set. It has been approved by the Research Ethics Committee of Tung Wah College, Hong Kong (reference number: REC2022136). The findings will be disseminated in peer-reviewed journals and presented at international conferences relevant to the subject fields. TRIAL REGISTRATION: The trial has been registered at ClinicalTrials.gov (Identifier: NCT05758740) and all items come from the World Health Organization Trial Registration Data Set. The latest version of the protocol was published online on 7th March 2023.
背景:认知脆弱是许多老年人常见的不良健康结果的风险。已知身体活动有助于预防认知脆弱,但老年人身体活动不足的情况仍然很高。电子健康通过一种创新的方式来提供行为改变方法,从而增强行为改变效果,增强了行为改变效果。然而,它对认知脆弱的老年人的影响、与传统行为改变方法的比较以及效果的可持续性尚不清楚。
方法:本研究采用单盲、两平行组、非劣效性、随机对照试验设计,组间分配比为 1:1。合格的参与者年龄在 60 岁或以上,有认知脆弱和身体不活动,并且拥有智能手机超过六个月。该研究将在社区环境中进行。在干预组中,参与者将接受为期两周的快走训练,然后接受为期 12 周的电子健康干预。在对照组中,参与者将接受为期两周的快走训练,然后接受为期 12 周的传统行为改变干预。主要结果是中等至剧烈体力活动(MVPA)的分钟数。本研究计划招募 184 名参与者。广义估计方程(GEE)将用于检验干预的效果。
伦理和传播:该试验于 2023 年 3 月 7 日在 ClinicalTrials.gov 上注册(标识符:NCT05758740),https://clinicaltrials.gov/ct2/show/NCT05758740,所有条目均来自世界卫生组织试验注册数据集中。它已获得香港东华学院研究伦理委员会的批准(参考号:REC2022136)。研究结果将发表在同行评议的期刊上,并在与主题领域相关的国际会议上展示。
试验注册:该试验已在 ClinicalTrials.gov 上注册(标识符:NCT05758740),所有条目均来自世界卫生组织试验注册数据集中。该方案的最新版本于 2023 年 3 月 7 日在线发布。
Cochrane Database Syst Rev. 2022-2-1
Bioinformation. 2024-12-31
Eur Rev Aging Phys Act. 2020-4-21
BMC Med Res Methodol. 2019-7-3
Mayo Clin Proc. 2019-3-11