Zhong Xiaoyong, Yan Xinghui, Liang Hui, Xia Rui, Chen Bin, Zhao Hong-Jia
Department of Neurology, The Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, China.
Department of Physical Education, Fujian University of Traditional Chinese Medicine, Fuzhou, China.
BMJ Open. 2021 Feb 8;11(2):e042177. doi: 10.1136/bmjopen-2020-042177.
Cerebral small vessel disease (CSVD) is a critical factor that causes cognitive decline and progresses to vascular dementia and acute cerebrovascular events. Tai chi has been proven to improve nerve plasticity formation and directly improve cognitive function compared with other sports therapy, which has shown its unique advantages. However, more medical evidence needs to be collected in order to verify that Tai chi exercises can improve cognitive impairment due to CSVD. The main purposes of this study are to investigate the effect of Tai chi exercise on neuropsychological outcomes of patients with cognitive impairment related to CSVD and to explore its mechanism of action with neuroimaging, including functional MRI (fMRI) and event-related potential (P300).
The design of this study is a randomised controlled trial with two parallel groups in a 1:1 allocation ratio with allocation concealment and assessor blinding. A total of 106 participants will be enrolled and randomised to the 24-week Tai chi exercise intervention group and 24-week health education control group. Global cognitive function and the specific domains of cognition (memory, processing speed, executive function, attention and verbal learning and memory) will be assessed at baseline and 12 and 24 weeks after randomisation. At the same time, fMRI and P300 will be measured the structure and function of brain regions related to cognitive function at baseline and 24 weeks after randomisation. Recruitment is currently ongoing (recruitment began on 9 November 2020). The approximate completion date for recruitment is in April 2021, and we anticipate to complete the study by December 2021.
Ethics approval was given by the Medical Ethics Committee of the Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine (approval number: 2019-058-04). The findings will be disseminated through peer-reviewed publications and at scientific conferences.
ChiCTR2000033176; Pre-results.
脑小血管病（CSVD）是导致认知功能下降并进展为血管性痴呆和急性脑血管事件的关键因素。与其他运动疗法相比，太极拳已被证明可改善神经可塑性形成并直接改善认知功能，显示出其独特优势。然而，需要收集更多医学证据来证实太极拳练习可改善CSVD所致的认知障碍。本研究的主要目的是探讨太极拳练习对CSVD相关认知障碍患者神经心理结局的影响，并通过神经影像学（包括功能磁共振成像（fMRI）和事件相关电位（P300））探索其作用机制。
本研究设计为随机对照试验，采用1:1分配比例的两个平行组，实施分配隐藏和评估者盲法。共招募106名参与者，随机分为24周太极拳练习干预组和24周健康教育对照组。在基线以及随机分组后12周和24周评估整体认知功能以及认知的特定领域（记忆、处理速度、执行功能、注意力以及言语学习和记忆）。同时，在基线以及随机分组后24周测量fMRI和P300，以评估与认知功能相关脑区的结构和功能。目前正在进行招募（招募于2020年11月9日开始）。预计招募完成日期为2021年4月，我们预计在2021年12月完成本研究。
福建中医药大学附属人民医院医学伦理委员会已给予伦理批准（批准号：2019 - 058 - 04）。研究结果将通过同行评审出版物和科学会议进行传播。
ChiCTR2000033176；预结果。
