Cao Richard Y, Zheng Hongchao, Mi Qiongyao, Li Qing, Yuan Wenchao, Ding Yueyou, Yang Jian
The Joint Laboratory of Cardiac Rehabilitation, Shanghai Xuhui Central Hospital & Shanghai University, 966 Middle Huaihai Road, 200031 & 99 Shangda Road, Shanghai, 200444, China.
Trials. 2018 Jul 9;19(1):363. doi: 10.1186/s13063-018-2771-8.
Cardiovascular disease is the leading cause of morbidity and mortality in the world, including China. Cardiac rehabilitation (CR) has been demonstrated to be beneficial in reducing cardiovascular mortality, myocardial infarction, and cerebrovascular events. This pilot study seeks to assess the feasibility of aerobic-exercise-based CR in Chinese patients with coronary heart disease (CHD) and outcomes of aerobic metabolism capacity and molecular biomarkers.
METHODS/DESIGN: This study is a single-center, pilot, randomized, controlled study that is currently being carried out at a regional hospital in Shanghai. Forty patients with CHD who underwent percutaneous coronary intervention will be randomly allocated into either the intervention group or control group. Participants in the intervention group will undergo 8 weeks of aerobic exercise with targeted intensity and participants in the control group will undergo 8 weeks of leisure exercise. The primary measurement is the feasibility of the trial; the secondary measurement is the capacity of aerobic metabolism and the exploratory measurement includes additional molecular biomarkers underlying cardiovascular function.
This is the first prospective randomized and controlled clinical study in China that assesses the parameters of aerobic metabolism and comprehensively screens for substantial blood biomarkers to reveal the molecular mechanisms underlying changes in cardiovascular function after aerobic exercise with targeted intensity in participants with CHD. The success of this study will contribute to guide the design of future CR studies in patients with CHD in China.
Chinese Clinical Trial Registry, ChiCTR-IPR-17010556 . Registered on 1 June 2016.
心血管疾病是包括中国在内的全球发病和死亡的主要原因。心脏康复（CR）已被证明有助于降低心血管死亡率、心肌梗死和脑血管事件。这项初步研究旨在评估以有氧运动为基础的心脏康复在中国冠心病（CHD）患者中的可行性以及有氧运动能力和分子生物标志物的结果。
方法/设计：本研究是一项单中心、初步、随机对照研究，目前正在上海的一家地区医院进行。40例接受经皮冠状动脉介入治疗的冠心病患者将被随机分配到干预组或对照组。干预组参与者将进行8周的有针对性强度的有氧运动，对照组参与者将进行8周的休闲运动。主要测量指标是试验的可行性；次要测量指标是有氧代谢能力，探索性测量指标包括心血管功能潜在的其他分子生物标志物。
这是中国第一项前瞻性随机对照临床研究，评估有氧代谢参数并全面筛查大量血液生物标志物，以揭示冠心病患者在进行有针对性强度的有氧运动后心血管功能变化的分子机制。本研究的成功将有助于指导中国未来冠心病患者心脏康复研究的设计。
中国临床试验注册中心，ChiCTR-IPR-17010556。于2016年6月1日注册。
