Effectiveness of Remotely Monitored Home-Based Baduanjin using Wearable Devices for Elder Patients after coronary revascularization: A Study Protocol for a Randomized Controlled Trial

Introduction: Coronary artery disease(CAD) is a prevalent cardiovascular disorder, and coronary revascularization, including percutaneous coronary intervention(PCI) and coronary artery bypass grafting(CABG), is a common treatment. However, many patients still suffer from cardiopulmonary dysfunction after the surgery. Baduanjin, a traditional Chinese exercise, may have potential benefits for these patients, but evidence is limited. This trial aims to determine the effectiveness and safety of remotely monitored home-based Baduanjin for post-coronary revascularization patients with cardiopulmonary dysfunction. Methods and analysis: This is a multicenter, assessor-blinded, two-armed randomized controlled trial. Three hundred and ninety-eight patients will be recruited from China-Japan Friendship Hospital, Fuwai Hospital, Xuanwu Hospital, and Guang'anmen Hospital, and randomly assigned to two groups (group A or group B) in a 1:1 ratio. Patients in group A will receive remotely monitored home-based Baduanjin training combined with conventional secondary prevention education of CHD, while patients in group B will receive conventional secondary prevention education alone for 12 weeks. The primary outcome will be the peak oxygen uptake (VO 2 peak) obtained from cardiopulmonary exercise testing (CPET) at week 12 compared with baseline. Secondary outcomes will include 6-minute walk distance (6MWD), Seattle Angina Questionnaire (SAQ), health-related quality of life measured by EQ-5D-VAS and EQ-5D-5L, left ventricular ejection fraction (LVEF), anxiety and depression scales (GAD-7 and PHQ-9), Montreal Cognitive Assessment (MoCA), composite cardiovascular events (including re-revascularization, AMI, death, stroke, heart failure rehospitalization), and other relevant indicators at weeks 0, 4, 8, and 12. Safety indicators will be monitored throughout the trial. Ethics and dissemination: This study has been approved by the clinical research ethics committee of China-Japan Friendship Hospital (No.2024-KY-031), the results of this study will be disseminated via peer-reviewed publications or conference presentations. Trial registration number: Chinese Clinical Trial Registry (No. ChiCTR2400088668, https://www.chictr.org.cn/showproj.html?proj=232409 ) registered on 23 August 2024.