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

This study has been completed.
Sponsor:
Collaborators:
Centro Hospitalar de Vila Nova de Gaia/Espinho
Research Center in Physical Activity, Health and Leisure, Portugal
Information provided by (Responsible Party):
Jose Manuel Fernandes Oliveira, Universidade do Porto
ClinicalTrials.gov Identifier:
NCT01432639
First received: September 7, 2011
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Other: Exercise-based cardiac rehabilitation program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Exercise Training on Endothelial Function, Inflammation, Arterial Stiffness and Autonomic Function in Coronary Artery Disease Patients

Resource links provided by NLM:


Further study details as provided by Universidade do Porto:

Primary Outcome Measures:
  • Autonomic Function [ Time Frame: Change from Baseline in Autonomic Function at 8 weeks of Cardiac Rehabilitation Program ] [ Designated as safety issue: No ]
    Autonomic function will be assessed by resting heart rate variability, heart rate recovery after maximal exercise and circulating levels of norepinephrine and epinephrine.


Secondary Outcome Measures:
  • Arterial Stiffness [ Time Frame: Change from Baseline in Arterial Stiffness at 8 weeks of Cardiac Rehabilitation Program ] [ Designated as safety issue: No ]
    Arterial Stiffness will be assessed by carotid-femoral pulse wave velocity and the aortic augmentation index.

  • Endothelial Function [ Time Frame: Change from Baseline in Endothelial Function at 8 weeks of Cardiac Rehabilitation Program ] [ Designated as safety issue: No ]
    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).

  • Cardiorespiratory Fitness [ Time Frame: Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Program ] [ Designated as safety issue: No ]
    Maximal or symptom-limited treadmill exercise testing will be conducted using the modified Bruce protocol.

  • Inflammatory Biomarkers [ Time Frame: Change from Baseline in Inflammatory Biomarkers at 8 weeks of Cardiac Rehabilitation Program ] [ Designated as safety issue: No ]
    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).

  • Anthropometrics [ Time Frame: Change from Baseline in Anthropometrics at 8 weeks of Cardiac Rehabilitation Program ] [ Designated as safety issue: No ]
    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).

  • Blood Pressure [ Time Frame: Change from Baseline in Blood Pressure at 8 weeks of Cardiac Rehabilitation Program ] [ Designated as safety issue: No ]
    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).

  • Dietary Intake [ Time Frame: Change from Baseline in Dietary Intake at 8 weeks of Cardiac Rehabilitation Program ] [ Designated as safety issue: No ]
    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).

  • Daily Physical Activity [ Time Frame: Change from Baseline in Daily Physical Activity at 8 weeks of Cardiac Rehabilitation Program ] [ Designated as safety issue: No ]
    Physical activity will be objectively measured for 7 consecutive days using the ActiGraph accelerometer (model GT1M, Florida, USA).

  • Biochemical Parameters [ Time Frame: Change from Baseline in Biochemical Parameters at 8 weeks of Cardiac Rehabilitation Program ] [ Designated as safety issue: No ]
    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.


Enrollment: 96
Study Start Date: May 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental group
Patients undergoing the exercise-based cardiac rehabilitation program (intervention)
Other: Exercise-based cardiac rehabilitation program
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 Name: Cardiac rehabilitation program
No Intervention: Control group
Usual medical care

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432639

Locations
Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Portugal, 4434-502
Sponsors and Collaborators
Universidade do Porto
Centro Hospitalar de Vila Nova de Gaia/Espinho
Research Center in Physical Activity, Health and Leisure, Portugal
Investigators
Study Chair: Jose Oliveira, PhD Research Center in Physical Activity, Health and Leisure, Portugal
Study Director: Fernando Ribeiro, PhD Research Center in Physical Activity, Health and Leisure, Portugal
Principal Investigator: Nórton L Oliveira, MSc Research Center in Physical Activity, Health and Leisure, Portugal
Principal Investigator: Madalena Teixeira, MD Centro Hospitalar de Vila Nova de Gaia/Espinho
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jose Manuel Fernandes Oliveira, Professor, Universidade do Porto
ClinicalTrials.gov Identifier: NCT01432639     History of Changes
Other Study ID Numbers: PTDC/DES/113753/2009
Study First Received: September 7, 2011
Last Updated: June 5, 2013
Health Authority: Portugal: Health Ethic Committee

Keywords provided by Universidade do Porto:
Myocardial infarction
Autonomic function
Arterial Stiffness
Endothelial function
Inflammation
Rehabilitation program
Exercise

Additional relevant MeSH terms:
Arteritis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Inflammation
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014