Safety and effectiveness of a Tai Chi-based cardiac rehabilitation programme for chronic coronary syndrom patients: study protocol for a randomised controlled trial

Author: Jing Ma#1, Jian Wei Zhang#2, Hua Li3, Lian Shan Zhao4, Ai Ying Guo3, Zai Hao Chen5, Wen Yuan5, Tian Ming Gao2, Ya Meng Li2, Cui Han Li5, Hong Wei Wang2, Bo Song2, Yu Long Lu2, Mei Ze Cui2, Qiu Yang Wei2, Shao Jun Lyu6, Heng Chan Yin6
1 Department of Cardiology, First Medical Center of Chinese People's Libration Army General Hospital, Beijing, China.
2 College of Physical Education and Sports, Beijing Normal University, Beijing, China.
3 Department of Cardiovascular Medicine, Anzhen Community Health Service Center, Chaoyang District, Beijing, China.
4 Department of Cardiovascular Medicine, Beijing Shuili Hospital, Beijing, China.
5 College of Wushu, Beijing Sport University, Beijing, China.
6 College of Physical Education and Sports, Beijing Normal University, Beijing, China

Conference/Journal: BMJ Open
Date published: 2020 Jul 5
Other: Volume ID: 10 , Issue ID: 7 , Pages: e036061 , Special Notes: doi: 10.1136/bmjopen-2019-036061. , Word Count: 319

Preliminary evidence from clinical observations suggests that Tai Chi exercise may offer potential benefits for patients with chronic coronary syndrom (CCS). However, the advantages for CCS patients to practice Tai Chi exercise as rehabilitation have not been rigorously tested and there is a lack of consensus on its benefits. This study aims to develop an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for CCS patients and to assess the efficacy, safety and acceptability of the programme.

Methods and analysis:
We propose to conduct a multicentre randomised controlled clinical trial comprising of 150 participants with CCS. The patients will be randomly assigned in a 1:1 ratio into two groups. The intervention group will participate in a supervised TCCRP held three times a week for 3 months. The control group will receive supervised conventional exercise rehabilitation held three times a week for 3 months. The primary and secondary outcomes will be assessed at baseline, 1 month, 3 months after intervention and after an additional 3-month follow-up period. Primary outcome measures will include a score of 36-Item Short Form Survey and Chinese Perceived Stress Scale. The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination. Other measures also include Seattle Angina Scale, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Berg Balance Scale. All adverse events will be recorded and analysed.

Ethics and dissemination:
This study conforms to the principles of the Declaration of Helsinki and relevant ethical guidelines. Ethical approval has been obtained from the Ethics Committee of Chinese People's Libration Army General Hospital (approval number: S2019-060-02). Findings from this study will be published and presented at conferences for widespread dissemination of the results.

Trial registration number:

Keywords: clinical trials; complementary medicine; coronary heart disease; education & training (see medical education & training); rehabilitation medicine; sports medicine.

PMID: 32624473 PMCID: PMC7337900 DOI: 10.1136/bmjopen-2019-036061