An interventional study of Exercise-based cardiac rehabilitation program in Coronary Artery Disease, sponsored by Universidade do Porto. Completed at 1 site in Portugal. Per ClinicalTrials.gov, last updated 2013-06-06.
Sponsored by Universidade do Porto · Not applicable, Interventional, and Treatment
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 96 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Universidade do Porto is the lead sponsor of 170 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
Patients undergoing the exercise-based cardiac rehabilitation program (intervention)
Other: Exercise-based cardiac rehabilitation program
Usual medical care
The intervention consists of usual medical care (i.e., medicine prescription and counseling of lifestyle modifications) and an supervised outpatient aerobic exercise training, which will be performed 3 days per week for 8 weeks. Each exercise session include 10 min of warm up, 35 min of aerobic exercise (i.e., cycloergometer or treadmill) and 10 min of cool down. The exercise intensity will be calculated as 65- 75% of maximal heart rate achieved in the treadmill exercise testing. Individualized exercise prescription will be periodically adjusted. A perceived exertion scale will be used as an adjunctive intensity modulator. In addition, each patient will be encouraged to daily exercise outside the formal exercise program.
Also known as: Cardiac rehabilitation program
Autonomic Function
Autonomic function will be assessed by resting heart rate variability, heart rate recovery after maximal exercise and circulating levels of norepinephrine and epinephrine.
Time frame: Change from Baseline in Autonomic Function at 8 weeks of Cardiac Rehabilitation Program
Arterial Stiffness
Arterial Stiffness will be assessed by carotid-femoral pulse wave velocity and the aortic augmentation index.
Time frame: Change from Baseline in Arterial Stiffness at 8 weeks of Cardiac Rehabilitation Program
Endothelial Function
Using commercially available assay kits (R\&D Systems, Minneapolis, MN, USA), the serum levels of sICAM-1 and sVCAM-1 will be measured in serum by an enzyme-linked immunosorbent assay (ELISA) according to the manufacturer's instructions and read at 450 nm using a microplate reader (Labsystems iEMS MF controlled by Ascent software v. 2.4, Dynex Labsystems).
Time frame: Change from Baseline in Endothelial Function at 8 weeks of Cardiac Rehabilitation Program
Cardiorespiratory Fitness
Maximal or symptom-limited treadmill exercise testing will be conducted using the modified Bruce protocol.
Time frame: Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Program
Inflammatory Biomarkers
Using commercially available assay kits (R\&D Systems, Minneapolis, MN, USA), the serum levels of CRP, IL-10 and IL-6 will be measured in serum by an enzyme-linked immunosorbent assay (ELISA) according to the manufacturer's instructions and read at 450 nm using a microplate reader (Labsystems iEMS MF controlled by Ascent software v. 2.4, Dynex Labsystems).
Time frame: Change from Baseline in Inflammatory Biomarkers at 8 weeks of Cardiac Rehabilitation Program
Anthropometrics
Height and weight measurements will be assessed using a standard wall-mounted stadiometer and portable digital beam scale (SECA, 708), respectively. Body mass index will be calculated from the ratio of weight (kg) to squared height (m2). Percentage of fat mass will be estimated by bioelectrical impedance analysis (BC-532, Tanita, Tokyo, Japan).
Time frame: Change from Baseline in Anthropometrics at 8 weeks of Cardiac Rehabilitation Program
Blood Pressure
Resting systolic and diastolic blood pressure will be measured using a digital automatic blood pressure monitor (Omron Pressmate BP10, Omron Healthcare Co., Ltd, Kyoto, Japan).
Time frame: Change from Baseline in Blood Pressure at 8 weeks of Cardiac Rehabilitation Program
Dietary Intake
Dietary intake will be assessed using a 4-day food diary as representative of the usual intake. Patients will be asked to provide detailed information concerning the food and beverages intake for four days (Sunday and 3-week days).
Time frame: Change from Baseline in Dietary Intake at 8 weeks of Cardiac Rehabilitation Program
Daily Physical Activity
Physical activity will be objectively measured for 7 consecutive days using the ActiGraph accelerometer (model GT1M, Florida, USA).
Time frame: Change from Baseline in Daily Physical Activity at 8 weeks of Cardiac Rehabilitation Program
Biochemical Parameters
Fasting plasma glucose, total cholesterol, high-density lipoprotein cholesterol, triglycerides, and HbA1c will be measured by enzymatic methods (912 automatic analyzer, Roche Diagnostic, Basel, Switzerland). Low-density lipoprotein cholesterol will be calculated using the Friedewald equation, except if triglycerides \> 400 mg/dL.
Time frame: Change from Baseline in Biochemical Parameters at 8 weeks of Cardiac Rehabilitation Program
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Universidade do Porto