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音乐和运动干预对轻度认知障碍患者认知、感觉运动和大脑衰退的影响(COPE):一项多中心随机对照研究的研究方案。

Musical and psychomotor interventions for cognitive, sensorimotor, and cerebral decline in patients with Mild Cognitive Impairment (COPE): a study protocol for a multicentric randomized controlled study.

机构信息

Geneva School of Health Sciences, Geneva Musical Minds Lab (GEMMI lab), University of Applied Sciences and Arts Western Switzerland HES-SO, Avenue de Champel 47, 1206, Geneva, Switzerland.

Faculty of Psychology and Educational Sciences, University of Geneva, Boulevard Carl-Vogt 101, 1205, Geneva, Switzerland.

出版信息

BMC Geriatr. 2023 Feb 6;23(1):76. doi: 10.1186/s12877-022-03678-0.

Abstract

BACKGROUND

Regular cognitive training can boost or maintain cognitive and brain functions known to decline with age. Most studies administered such cognitive training on a computer and in a lab setting. However, everyday life activities, like musical practice or physical exercise that are complex and variable, might be more successful at inducing transfer effects to different cognitive domains and maintaining motivation. "Body-mind exercises", like Tai Chi or psychomotor exercise, may also positively affect cognitive functioning in the elderly. We will compare the influence of active music practice and psychomotor training over 6 months in Mild Cognitive Impairment patients from university hospital memory clinics on cognitive and sensorimotor performance and brain plasticity. The acronym of the study is COPE (Countervail cOgnitive imPairmEnt), illustrating the aim of the study: learning to better "cope" with cognitive decline.

METHODS

We aim to conduct a randomized controlled multicenter intervention study on 32 Mild Cognitive Impairment (MCI) patients (60-80 years), divided over 2 experimental groups: 1) Music practice; 2) Psychomotor treatment. Controls will consist of a passive test-retest group of 16 age, gender and education level matched healthy volunteers. The training regimens take place twice a week for 45 min over 6 months in small groups, provided by professionals, and patients should exercise daily at home. Data collection takes place at baseline (before the interventions), 3, and 6 months after training onset, on cognitive and sensorimotor capacities, subjective well-being, daily living activities, and via functional and structural neuroimaging. Considering the current constraints of the COVID-19 pandemic, recruitment and data collection takes place in 3 waves.

DISCUSSION

We will investigate whether musical practice contrasted to psychomotor exercise in small groups can improve cognitive, sensorimotor and brain functioning in MCI patients, and therefore provoke specific benefits for their daily life functioning and well-being.

TRIAL REGISTRATION

The full protocol was approved by the Commission cantonale d'éthique de la recherche sur l'être humain de Genève (CCER, no. 2020-00510) on 04.05.2020, and an amendment by the CCER and the Commission cantonale d'éthique de la recherche sur l'être humain de Vaud (CER-VD) on 03.08.2021. The protocol was registered at clinicaltrials.gov (20.09.2020, no. NCT04546451).

摘要

背景

有规律的认知训练可以促进或维持认知和大脑功能,这些功能随着年龄的增长而下降。大多数研究都是在计算机上和实验室环境中进行这种认知训练。然而,日常生活活动,如音乐练习或体育锻炼,可能更成功地诱导不同认知领域的转移效应,并保持动机。“身心练习”,如太极或精神运动练习,也可能对老年人的认知功能产生积极影响。我们将比较 6 个月内在大学医院记忆诊所的轻度认知障碍患者中进行积极的音乐练习和精神运动训练对认知和感觉运动表现以及大脑可塑性的影响。该研究的缩写是 COPE(Countervail cOgnitive imPairmEnt),说明了研究的目的:学习更好地“应对”认知能力下降。

方法

我们旨在对 32 名轻度认知障碍(MCI)患者(60-80 岁)进行随机对照多中心干预研究,分为 2 个实验组:1)音乐练习;2)精神运动治疗。对照组将由 16 名年龄、性别和教育水平匹配的健康志愿者组成,他们将进行被动测试-再测试。训练方案在 6 个月内每周进行 2 次,每次 45 分钟,由专业人员提供,患者应在家中每天进行锻炼。数据收集在基线(干预前)、3 个月和 6 个月后进行,包括认知和感觉运动能力、主观幸福感、日常生活活动以及功能和结构神经影像学。考虑到当前 COVID-19 大流行的限制,招募和数据收集分 3 波进行。

讨论

我们将研究音乐练习与小组中的精神运动练习相比是否可以改善 MCI 患者的认知、感觉运动和大脑功能,从而为他们的日常生活功能和幸福感带来特定的益处。

试验注册

完整的方案于 2020 年 5 月 4 日获得日内瓦人类研究伦理委员会(CCER,编号 2020-00510)的批准,并于 2021 年 8 月 3 日由 CCER 和沃州人类研究伦理委员会(CER-VD)修订。该方案于 2020 年 9 月 20 日在临床试验.gov 上注册(20.09.2020,编号 NCT04546451)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a44c/9901118/af0da1b4efb5/12877_2022_3678_Fig1_HTML.jpg

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