Cai Yinhe, Kang Liang, Li Haiyi, Luo Yuan, Wen Junmao, Gong Zhaohui, Chu Qingmin, Qiu Yijun, Luo Chuanjin, Chen Keyu, Zhao Xinjun, Li Rong
The First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, China.
Department of Cardiovascular Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Front Cardiovasc Med. 2022 Feb 9;9:778583. doi: 10.3389/fcvm.2022.778583. eCollection 2022.
Left ventricular (LV) remodeling after ST-segment elevation myocardial infarction (STEMI) is a major pathological basis associated with heart failure and increased mortality. Exercise-based cardiac rehabilitation has been verified to significantly improve prognosis and quality of life. As a traditional Chinese Qigong, Baduanjin exercise has effectively alleviated adverse LV remodeling in STEMI patients. Despite this, participation in exercise rehabilitation remains low, and home-based exercise rehabilitation may be an alternative approach. Besides, anterior STEMI is reported to have higher risk of adverse LV remodeling. However, the efficiency regarding home-based Baduanjin exercise on LV remodeling in anterior STEMI patients remains uncertain currently.
METHODS/DESIGN: A single-blind, randomized controlled clinical trial was conducted to explore the efficacy and safety of home-based Baduanjin exercise in anterior STEMI patients compared with moderate intensity aerobic walking. A total of 114 participants were assigned randomly to the Baduanjin group or walking control group at a 1:1 ratio. Eligible participants practiced Baduanjin or walking exercise (5 times a week) for 12 weeks, and then followed up for another 12 weeks. The primary outcome is a relative change in the LV end-diastolic volume. The secondary outcomes include the plasma levels of hypersensitive C-reactive protein and interleukin 6, health-related quality of life measured by EQ-5D-5L, LV ejection fraction, patient health questionnaire-9, generalized anxiety disorder screener-7, short physical performance battery score, and clinical endpoint events. The proportion of circulating regulatory T-cells were also assessed. Adverse events were recorded throughout the trial for safety evaluation. Data were be analyzed by researchers blinded to the treatment allocation.
This study provided powerful evidence for the use of home-based Baduanjin exercise in anterior STEMI patients in alleviating LV remodeling and improving clinical outcomes.
The Research Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine has approved this study (ZYYECK[2020]045). Written informed consent of patients were required. This trial is registered in the Chinese Clinical Trial Registry (ChiCTR2100047298).
Our results will be published in peer-reviewed journals and disseminated through academic conferences and the Internet.
ST段抬高型心肌梗死（STEMI）后左心室（LV）重构是与心力衰竭和死亡率增加相关的主要病理基础。基于运动的心脏康复已被证实可显著改善预后和生活质量。作为一种传统的中国气功，八段锦运动已有效减轻STEMI患者的不良左心室重构。尽管如此，运动康复的参与率仍然很低，而家庭运动康复可能是一种替代方法。此外，据报道，前壁STEMI发生不良左心室重构的风险更高。然而，目前家庭八段锦运动对前壁STEMI患者左心室重构的效果仍不确定。
方法/设计：进行了一项单盲、随机对照临床试验，以探讨与中等强度有氧运动相比，家庭八段锦运动对前壁STEMI患者的疗效和安全性。总共114名参与者按1:1的比例随机分配到八段锦组或步行对照组。符合条件的参与者每周进行5次八段锦或步行运动共12周，然后再随访12周。主要结局是左心室舒张末期容积的相对变化。次要结局包括超敏C反应蛋白和白细胞介素6的血浆水平、用EQ-5D-5L测量的健康相关生活质量、左心室射血分数、患者健康问卷-9、广泛性焦虑障碍筛查量表-7、简短体能测试电池得分以及临床终点事件也进行了评估。还评估了循环调节性T细胞的比例。在整个试验过程中记录不良事件以进行安全性评估。数据由对治疗分配不知情的研究人员进行分析。
本研究为家庭八段锦运动用于前壁STEMI患者减轻左心室重构和改善临床结局提供了有力证据。
广州中医药大学第一附属医院研究伦理委员会已批准本研究（ZYYECK[2020]045）。需要患者的书面知情同意书。本试验在中国临床试验注册中心注册（ChiCTR2100047298）。
我们的结果将发表在同行评审期刊上，并通过学术会议和互联网进行传播。
