八段锦锻炼对脑卒中后认知障碍患者认知功能的影响：一项随机对照试验的研究方案。
Effect of Baduanjin exercise on cognitive function in patients with post-stroke cognitive impairment: study protocol for a randomised controlled trial.
机构信息
College of Nursing and Health Management, Shanghai University of Medicine & Health Sciences, Shanghai, China.
College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.
出版信息
BMJ Open. 2018 Jun 22;8(6):e020954. doi: 10.1136/bmjopen-2017-020954.
INTRODUCTION
Poststroke cognitive impairment is one of the most common complications in stroke survivors, and >65% of these patients suffer from cognitive impairment at 12 months following onset, which strongly affects the rehabilitation of their motor function and quality of life. Therefore, it is important to improve the cognitive ability of stroke survivors. As an important component of traditional Chinese Qigong exercises, characterised by the coordination of mind and body with a low exercise intensity, Baduanjin has the potential benefit of improving cognitive ability for patients who had a stroke with cognitive impairment. The primary purpose of this study is to investigate the effectiveness and safety of Baduanjin training on the cognitive function of stroke survivors.
METHOD AND ANALYSIS
This study is designed as a randomised, two-arm parallel controlled trial with allocation concealment and assessors blinding. A total of 48 participants will be recruited and randomly allocated into the Baduanjin exercise intervention or control group. Baduanjin intervention will last 24 weeks with a frequency of 3 days a week and 40 min a day. Global cognitive function and the specific domains of cognition (ie, memory, processing speed, execution, attention and visuospatial ability) will be measured at baseline, 8, 16 and, 24 weeks after intervention and after an additional 4-week follow-up period, while the motor function and quality of life will be measured at baseline, 24 weeks after intervention and after an additional 4-week follow-up period.
ETHICS AND DISSEMINATION
Ethics approval was obtained from the Ethics Committee of Fujian University of Traditional Chinese Medicine Subsidiary Rehabilitation Hospital (approval number: 2016KY-022-01). The findings will be disseminated through peer-reviewed publications and at scientific conferences.
TRIAL REGISTRATION NUMBER
ChiCTR-INR-16009364; Pre-results.
简介
脑卒中后认知障碍是脑卒中幸存者最常见的并发症之一，其中>65%的患者在发病后 12 个月会出现认知障碍，这强烈影响了他们运动功能的康复和生活质量。因此，提高脑卒中幸存者的认知能力非常重要。八段锦作为中国传统气功的重要组成部分，以身心协调、运动强度低为特点，可能有助于改善有认知障碍的脑卒中患者的认知能力。本研究的主要目的是研究八段锦训练对脑卒中幸存者认知功能的有效性和安全性。
方法和分析
这是一项随机、两臂平行对照试验，采用分配隐藏和评估者盲法。共招募 48 名参与者，随机分为八段锦运动干预组或对照组。八段锦干预将持续 24 周，每周 3 天，每天 40 分钟。在干预前、干预后 8、16 和 24 周以及额外 4 周随访期，将测量总体认知功能和认知特定领域（即记忆、处理速度、执行、注意力和视空间能力），在干预前、干预后 24 周以及额外 4 周随访期，将测量运动功能和生活质量。
伦理和传播
福建中医药大学附属康复医院伦理委员会已批准本研究（批准号：2016KY-022-01）。研究结果将通过同行评议的出版物和科学会议进行传播。
试验注册号
ChiCTR-INR-16009364；预注册。
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