The Multi-domain Lifestyle Intervention for Cognitive Impairment in Community-Dwelling Older Adults in Hangzhou (The Heritage Study): Study Design and Protocol

Xin Xu, T. Pang, Y. Zhou, H. Zhang, A. Ma, C. Yuan, H. Chen, X. Wen, Q. Yang, X. Xu
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Abstract

Background

The globe has been working to promote a multi-domain lifestyle intervention for dementia prevention in older adults, referring to the Worldwide-FINGERS (Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability) initiative. In China, the multi-domain lifestyle intervention has been implemented in rural communities (MIND-China), yet the adaptability of such intervention based on the urban communities in China has not been verified.

Objective

To examine the effectiveness and feasibility of the multi-domain lifestyle intervention on dementia prevention in at-risk community-dwelling older adults in China.

Design, Setting, Participants

The multi-domain lifestyle intervention study is a community-based 2-year cluster randomized controlled trial (RCT). A total of 1200 participants aged 60–80 years old will be recruited from twelve communities in Hangzhou, Zhejiang. Inclusion criteria were the Montreal Cognitive Assessment 5 minutes protocol (5 min MoCA) score of 6–9 or the Ascertain Dementia 8 (AD 8) score of ≥2, and having modifiable lifestyle factors.

Intervention, Measurements, Results

Participating communities will be randomized into either the structured multi-domain intervention (SMI) arm or the self-guided intervention (SGI, general health education) arm. The SMI consists of cognitive training, physical exercise, and nutritional and dietary instruction for the first 12 months; and vascular risks monitoring and control for 24 months. The primary outcome is the global cognitive performance, measured by the comprehensive Neuropsychological Test Battery (NTB). The secondary outcomes include domain-specific cognitive performances, physical function, mental health, physiological and biochemical indices, adherence to healthy lifestyles, and neuroimaging metrics. The feasibility of intervention will be evaluated around the five dimensions of the RE-AIM framework and in conjunction with quantitative data, operational data and results of focus group discussions.

Conclusions

Following the Worldwide-FINGERS, this cluster RCT will verify the adaptability of the multi-domain lifestyle intervention in the urban community settings in China. This study will add evidence for global dementia prevention and management among older adults.

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杭州市社区老年人认知障碍的多领域生活方式干预(遗产研究):研究设计与方案
背景全球一直致力于推广多领域的生活方式干预,以预防老年人痴呆症的发生,并参考了 "芬兰预防认知障碍和残疾的老年干预研究"(Worldwide-FINGERS)项目。目的探讨多领域生活方式干预对中国高危社区老年人痴呆预防的有效性和可行性。设计、地点、参与者多领域生活方式干预研究是一项为期两年的社区分组随机对照试验(RCT)。研究将从浙江省杭州市的 12 个社区招募 1200 名 60-80 岁的参与者。纳入标准为蒙特利尔认知评估5分钟方案(5 min MoCA)评分6-9分或老年痴呆8分(AD 8)评分≥2分,且具有可改变的生活方式因素。干预、测量、结果参与社区将被随机分为结构化多领域干预(SMI)组或自我指导干预(SGI,普通健康教育)组。SMI 包括前 12 个月的认知训练、体育锻炼以及营养和饮食指导;24 个月的血管风险监测和控制。主要结果是全面认知能力,由综合神经心理测试电池(NTB)测量。次要结果包括特定领域的认知表现、身体功能、心理健康、生理和生化指标、健康生活方式的坚持情况以及神经影像学指标。干预的可行性将围绕 RE-AIM 框架的五个维度,结合定量数据、操作数据和焦点小组讨论结果进行评估。这项研究将为全球老年人痴呆症的预防和管理提供更多证据。
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The Journal of Prevention of Alzheimer's Disease
The Journal of Prevention of Alzheimer's Disease Medicine-Psychiatry and Mental Health
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9.20
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期刊介绍: The JPAD Journal of Prevention of Alzheimer’Disease will publish reviews, original research articles and short reports to improve our knowledge in the field of Alzheimer prevention including: neurosciences, biomarkers, imaging, epidemiology, public health, physical cognitive exercise, nutrition, risk and protective factors, drug development, trials design, and heath economic outcomes.JPAD will publish also the meeting abstracts from Clinical Trial on Alzheimer Disease (CTAD) and will be distributed both in paper and online version worldwide.We hope that JPAD with your contribution will play a role in the development of Alzheimer prevention.
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