Exploring the therapeutic mechanism of Baduanjin in the treatment of elderly stable angina pectoris based on the gut microbiota–lipid metabolism spectrum: Study protocol for a randomized controlled trial

Abstract

ImportanceStable 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.ObjectiveTo 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.DesignA single-center, single-blind, randomized controlled trial. Patients and outcome assessors were blinded to group allocation.SettingThe trial will be conducted at Guang'anmen Hospital of China Academy of Chinese Medical Sciences.ParticipantsOne 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.InterventionsAmong 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.Main and secondary resultsThe 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.DiscussionThis study provides compelling evidence for at-home use of Baduanjin exercise to relieve SAP-associated symptoms.Trial registrationThis 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).