Abstract
BackgroundCardiovascular 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/designThis 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.DiscussionThis 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.Trial registrationChinese Clinical Trial Registry, ChiCTR-IPR-17010556. Registered on 1 June 2016.
Highlights
Cardiovascular disease is the leading cause of morbidity and mortality in the world, including China
The success of this study will contribute to guide the design of future Cardiac rehabilitation (CR) studies in patients with coronary heart disease (CHD) in China
We designed a pilot, randomized, controlled trial to assess the feasibility of aerobic-exercise-based CR on aerobic metabolic capacity and substantial cardiovascular biomarkers in patients with CHD after percutaneous coronary intervention (PCI)
Summary
The benefits of CR are well-recognized in America and Europe and are widely recommended by the American Association of Cardiovascular and Pulmonary Rehabilitation and European Society of Cardiology as secondary prevention in patients with coronary disease [7, 22, 23]. The present pilot trial is the first clinical study that comprehensively screens multiple blood biomarkers to explore the potential underlying molecular mechanisms and changes in cardiovascular function after aerobic exercise-based CR training. Results of this pilot study can be used to predict the feasibility and operational acceptability of a future large-scale pivotal trial that promotes the generalization of the CR program in China. (DOCX 38 kb) Additional file 2: CONSORT checklist.
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