Effects of Exercise Training on Endothelial Function, Inflammation, Arterial Stiffness and Autonomic Function in Coronary Artery Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Autonomic Function
研究概览
简要总结
The main purposes of this study is to analyze, in a randomized controlled trial, the effects of an exercise-based cardiac rehabilitation program (i) on biomarkers of endothelial function, (ii) on biomarkers of inflammation, (iii) on autonomic function, and (iv) on arterial stiffness in coronary artery disease patients (CAD). Additionally, the investigators aim to analyze the (v) contribution of age and the changes in traditional risk factors to the modification of the endothelial dysfunction and inflammation, and (vi) the contribution of the changes in inflammatory and endothelial function biomarkers to the modification of autonomic function and arterial stiffness.
The investigators hypothesize that exercise training will improve the autonomic function, arterial stiffness and mitigate the endothelial dysfunction and inflammation in CAD patients even in the absence of significant changes in traditional risk factors. Thus, the investigators expect with the present study to promote, develop and expand the knowledge in this field by assessing the impact of exercise on a pool of markers that provide a wide picture of the pathophysiological processes underlying CAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute myocardial infarction
排除标准
- •ventricular tachyarrhythmia
- •uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg)
- •significant valvular disease
- •unstable angina pectoris
- •reduced left ventricular function (ejection fraction < 45%)
- •abnormal hemodynamic response
- •myocardial ischemia and/or severe ventricular arrhythmias during baseline exercise testing
- •uncontrolled metabolic disease (e.g. uncontrolled diabetes or thyroid disease)
- •presence of pulmonary and renal co-morbidities
- •peripheral artery disease and/or orthopedic limitations
研究组 & 干预措施
Experimental group
Patients undergoing the exercise-based cardiac rehabilitation program (intervention)
干预措施: Exercise-based cardiac rehabilitation program (Other)
Control group
Usual medical care
结局指标
主要结局
Autonomic Function
时间窗: Change from Baseline in Autonomic Function at 8 weeks of Cardiac Rehabilitation Program
Autonomic function will be assessed by resting heart rate variability, heart rate recovery after maximal exercise and circulating levels of norepinephrine and epinephrine.
次要结局
- Arterial Stiffness(Change from Baseline in Arterial Stiffness at 8 weeks of Cardiac Rehabilitation Program)
- Endothelial Function(Change from Baseline in Endothelial Function at 8 weeks of Cardiac Rehabilitation Program)
- Cardiorespiratory Fitness(Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Program)
- Inflammatory Biomarkers(Change from Baseline in Inflammatory Biomarkers at 8 weeks of Cardiac Rehabilitation Program)
- Anthropometrics(Change from Baseline in Anthropometrics at 8 weeks of Cardiac Rehabilitation Program)
- Blood Pressure(Change from Baseline in Blood Pressure at 8 weeks of Cardiac Rehabilitation Program)
- Dietary Intake(Change from Baseline in Dietary Intake at 8 weeks of Cardiac Rehabilitation Program)
- Daily Physical Activity(Change from Baseline in Daily Physical Activity at 8 weeks of Cardiac Rehabilitation Program)
- Biochemical Parameters(Change from Baseline in Biochemical Parameters at 8 weeks of Cardiac Rehabilitation Program)
研究者
Jose Manuel Fernandes Oliveira
Professor
Universidade do Porto