Yang Sha, Chen Jingwen, Guo Yuyi, Teng Yuke, Liu Tianyu, Ying Rongtao, He Zhaoxuan, Wu Jianwei, Yu Shu-Guang, Zeng Fang
Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
School of Gymnasium, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
BMJ Open. 2019 Aug 30;9(8):e031089. doi: 10.1136/bmjopen-2019-031089.
Taiji has been proven to be effective for regulating both the physical and mental state compared with simple aerobic exercise. However, whether the improvement of Taiji for constipation is related to regulate imbalanced brain-gut axis and emotional disorder for functional constipation (FC) remains uncertain. The results of the study will demonstrate the differences in regulation brain-gut balance between Taiji and simply aerobic exercise for patients with FC and provide a potential therapy for clinical treatment of FC, and a new approach for the research of mind-body exercise.
In this randomised controlled neuroimaging trial, 80 patients with FC will be allocated into two groups: Taiji group and aerobic exercise group. The two groups will receive 10 weeks of Taiji exercise or aerobic exercise, respectively. The stool diary, Cleveland Constipation Score and Patient Assessment of Constipation Symptom, Patient Assessment of Constipation Quality of Life Questionnaire will be used to evaluate the clinical efficacy, the Self-rating Depression Scale, Self-rating Anxiety Scale, Eysenck Personality Questionnaires and Mini-Mental State Examinations will be used to assess the mental state at the baseline, the 5-week intervention and the end of intervention. The 24-hour heart rate variability will be used for assessing the autonomic nervous function, functional MRI and positron emission tomography-CT will be performed for detecting the cerebral functional changes at the baseline and the end of the intervention. The clinical data and multimodal imaging data will be analysed, respectively. Correlation analysis will be conducted to investigate the relationship between cerebral functional changes and symptom improvement.
The procedures have been approved by the Sichuan Regional Ethics Review Committee on Traditional Chinese Medicine (No. 2018KL-047) and conformed to the Declaration of Helsinki. Results will be disseminated through policy briefs, workshops, peer-reviewed publications and conferences.
Chinese Clinical Trial Registry (ChiCTR1800019781).
与简单的有氧运动相比，太极拳已被证明在调节身心状态方面有效。然而，太极拳对便秘的改善是否与调节功能性便秘（FC）患者失衡的脑-肠轴和情绪障碍有关仍不确定。本研究结果将展示太极拳与简单有氧运动对FC患者调节脑-肠平衡的差异，为FC的临床治疗提供一种潜在疗法，并为身心运动研究提供一种新方法。
在这项随机对照神经影像学试验中，80例FC患者将被分为两组：太极拳组和有氧运动组。两组将分别接受为期10周的太极拳运动或有氧运动。使用大便日记、克利夫兰便秘评分、便秘症状患者评估、便秘生活质量患者评估问卷来评估临床疗效，使用自评抑郁量表、自评焦虑量表、艾森克人格问卷和简易精神状态检查表在基线、干预5周和干预结束时评估心理状态。使用24小时心率变异性评估自主神经功能，在基线和干预结束时进行功能磁共振成像和正电子发射断层扫描-CT以检测脑功能变化。将分别分析临床数据和多模态成像数据。进行相关性分析以研究脑功能变化与症状改善之间的关系。
该程序已获得四川省中医药区域伦理审查委员会批准（编号2018KL-047），并符合《赫尔辛基宣言》。结果将通过政策简报、研讨会、同行评审出版物和会议进行传播。
中国临床试验注册中心（ChiCTR1800019781）。
