Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Beijing University of Chinese Medicine, Beijing, China.
Front Public Health. 2022 Oct 31;10:1027839. doi: 10.3389/fpubh.2022.1027839. eCollection 2022.
Stable angina pectoris (SAP) often occurs in the elderly and is relatively stable for 1-3 months; however, if patients do not receive effective treatment, life-threatening acute myocardial infarction could occur. Patients with different clinical types of coronary heart disease have different intestinal flora. Baduanjin, a traditional Chinese Qigong, has been used as adjuvant therapy to improve the symptoms of patients with SAP.
To determine the effect of Baduanjin exercise on the symptoms of patients with SAP and the intestinal flora, explore the action links and targets of Baduanjin intervention in elderly patients with SAP, and explain its mechanism.
A single-center, single-blind, randomized controlled trial. Patients and outcome assessors were blinded to group allocation.
The trial will be conducted at Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
One hundred and eighty patients aged 60 to 80 years with stable angina pectoris (I-III) were intervened for 8 weeks and followed up for half a year.
Among the screened patients, 180 patients will be randomly assigned to either the Baduanjin or the control group at a 1:1 ratio (exercise duration: for 3-5 times a week, for 8 weeks) of moderate-intensity Baduanjin or free activities.
The main result is the total effective rate for angina pectoris symptoms; secondary results include the duration of angina pectoris, number of angina pectoris episodes per week, nitroglycerin consumption, nitroglycerin reduction rate, Seattle angina score (SAQ), quality of life (SF-36),Traditional Chinese Medicine (TCM) syndrome scores, electrocardiogram (ECG) changes, blood lipid serum hypersensitive C-reactive protein levels, intestinal flora changes, serum changes in the intestinal flora metabolite Trimetlylamine oxide (TMAO), and non-targeted liposome detection. Adverse events will be recorded throughout the experiment, and the data will be analyzed by researchers who did not know about the assignment.
This study provides compelling evidence for at-home use of Baduanjin exercise to relieve SAP-associated symptoms.
This study was approved by the ethics committee of Guang'anmen Hospital of China Academy of Chinese Medical Sciences (2022-121-KY). The trial has been registered in Chinese Clinical Trial Registration Center (ChiCTR2200062450).
稳定型心绞痛（SAP）常发生于老年人，1-3 个月内相对稳定；然而，如果患者未接受有效治疗，可能会发生危及生命的急性心肌梗死。不同临床类型的冠心病患者其肠道菌群存在差异。八段锦是一种传统的中国气功，已被用作辅助治疗以改善 SAP 患者的症状。
确定八段锦运动对 SAP 患者症状和肠道菌群的影响，探讨八段锦干预老年 SAP 患者的作用环节和靶点，解释其机制。
一项单中心、单盲、随机对照试验。患者和结局评估者对分组均设盲。
试验将在中国中医科学院广安门医院进行。
将 180 名年龄在 60-80 岁之间的稳定型心绞痛（I-III）患者进行干预 8 周，并随访半年。
在筛选出的患者中，将 180 名患者按照 1:1 的比例随机分为八段锦组或对照组（运动时间：每周 3-5 次，持续 8 周），分别进行中等强度的八段锦或自由活动。
主要结果是心绞痛症状的总有效率；次要结果包括心绞痛持续时间、每周心绞痛发作次数、硝酸甘油用量、硝酸甘油减少率、西雅图心绞痛量表（SAQ）、生活质量（SF-36）、中医（TCM）证候评分、心电图（ECG）变化、血脂血清超敏 C 反应蛋白水平、肠道菌群变化、血清中肠道菌群代谢物三甲胺氧化物（TMAO）变化、非靶向脂质体检测。整个实验过程中记录不良事件，数据分析由不了解分组的研究人员进行。
本研究为在家中使用八段锦运动缓解 SAP 相关症状提供了有力证据。
本研究经中国中医科学院广安门医院伦理委员会批准（2022-121-KY）。该试验已在中国临床试验注册中心（ChiCTR2200062450）注册。
