The effectiveness and safety of acupuncture kinesitherapy after percutaneous coronary intervention in patients with coronary heart disease: study protocol for a randomized controlled trial

BackgroundCoronary heart disease(CHD) is a common disease of the cardiovascular system. Percutaneous coronary intervention(PCI) has been proven an effective treatment. Various complications after PCI may further affect the long-term efficacy of PCI. Previous trials have showed that both kinesitherapy(KT) and acupuncture are beneficial to patients with CHD, but need further confirmation. Acupuncture kinesitherapy(AKT) is a kind of combination therapy of acupuncture with exercise training. In this study, we plan to conduct a randomized controlled trial(RCT) to confirm the superior efficacy of AKT compared to KT and conventional medical therapy(MT) in post-PCI rehabilitation for CHD patients, and to further guide the clinical strategy. MethodsThis is a single-center randomized controlled trial with 3 parallel arms. We will recruit 102 CHD patients after PCI and randomly assign them to 3 groups. Participants in 3 groups will receive 2-week MT. Besides, participants in AKT and KT groups will also receive acupuncture kinesitherapy and kinesitherapy alone, respectively. They will be treated once a day, 5-day a week, and the treatment course will last for a total of 2-week with a 2-day off during the course. The primary outcome is the changes in cardiac function. The secondary outcomes include aerobic capacity, muscle strength, flexibility, balance, coordination, mental status, and activity of daily living. All outcomes will be measured at baseline and 2-week after treatment. Adverse events also will be recorded. The cardiac function and activities of daily living will be followed up at 1, 3 and 6 months after treatment. DiscussionWe expect findings of trial will provide important insight into application of AKT as a safety and more effective method for CHD patients. Successful completion of this proposed study will also contribute to promotion of AKT in the clinic in the future. Trial registrationChinese clinical trial registry (Register Number: ChiCTR2100048960) http://www.chictr.org.cn/index.aspx.