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Completed

NCT Number: NCT01432639

Effects of Exercise Training on Endothelial Function, Inflammation, Arterial Stiffness and Autonomic Function in CAD

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Coronary Disease Heart Diseases Infarction Inflammation Ischemia Motor Activity Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar de Vila Nova de Gaia/Espinho

Vila Nova de Gaia, 4434-502, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • acute myocardial infarction

Exclusion criteria

  • 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

Treatment and study plan

Exercise-based cardiac rehabilitation program

Other

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.

Other names: Cardiac rehabilitation program

Primary outcomes

  1. Autonomic Function

    Time frame: 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.

Secondary outcomes

  1. Arterial Stiffness

    Time frame: Change from Baseline in Arterial Stiffness at 8 weeks of Cardiac Rehabilitation Program

    Arterial Stiffness will be assessed by carotid-femoral pulse wave velocity and the aortic augmentation index.

  2. Endothelial Function

    Time frame: Change from Baseline in Endothelial Function at 8 weeks of Cardiac Rehabilitation Program

    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).

  3. Cardiorespiratory Fitness

    Time frame: Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Program

    Maximal or symptom-limited treadmill exercise testing will be conducted using the modified Bruce protocol.

  4. Inflammatory Biomarkers

    Time frame: Change from Baseline in Inflammatory Biomarkers at 8 weeks of Cardiac Rehabilitation Program

    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).

  5. Anthropometrics

    Time frame: Change from Baseline in Anthropometrics at 8 weeks of Cardiac Rehabilitation Program

    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).

  6. Blood Pressure

    Time frame: Change from Baseline in Blood Pressure at 8 weeks of Cardiac Rehabilitation Program

    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).

  7. Dietary Intake

    Time frame: Change from Baseline in Dietary Intake at 8 weeks of Cardiac Rehabilitation Program

    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).

  8. Daily Physical Activity

    Time frame: Change from Baseline in Daily Physical Activity at 8 weeks of Cardiac Rehabilitation Program

    Physical activity will be objectively measured for 7 consecutive days using the ActiGraph accelerometer (model GT1M, Florida, USA).

  9. Biochemical Parameters

    Time frame: Change from Baseline in Biochemical Parameters at 8 weeks of Cardiac Rehabilitation Program

    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.

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

  • Centro Hospitalar de Vila Nova de Gaia/Espinho
  • Research Center in Physical Activity, Health and Leisure, Portugal

Registry information

Official study title

Effects of Exercise Training on Endothelial Function, Inflammation, Arterial Stiffness and Autonomic Function in Coronary Artery Disease Patients

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 13, 2011
Registry last updated
Jun 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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