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

June 5, 2013 updated by: Jose Manuel Fernandes Oliveira, Universidade do Porto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Vila Nova de Gaia, Portugal, 4434-502
        • Centro Hospitalar de Vila Nova de Gaia/Espinho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Cardiac rehabilitation program
No Intervention: Control group
Usual medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline in Autonomic Function at 8 weeks of Cardiac Rehabilitation Program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline in Arterial Stiffness at 8 weeks of Cardiac Rehabilitation Program
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).
Change from Baseline in Endothelial Function at 8 weeks of Cardiac Rehabilitation Program
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.
Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Program
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).
Change from Baseline in Inflammatory Biomarkers at 8 weeks of Cardiac Rehabilitation Program
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).
Change from Baseline in Anthropometrics at 8 weeks of Cardiac Rehabilitation Program
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).
Change from Baseline in Blood Pressure at 8 weeks of Cardiac Rehabilitation Program
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).
Change from Baseline in Dietary Intake at 8 weeks of Cardiac Rehabilitation Program
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).
Change from Baseline in Daily Physical Activity at 8 weeks of Cardiac Rehabilitation Program
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.
Change from Baseline in Biochemical Parameters at 8 weeks of Cardiac Rehabilitation Program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 7, 2011

First Submitted That Met QC Criteria

September 9, 2011

First Posted (Estimate)

September 13, 2011

Study Record Updates

Last Update Posted (Estimate)

June 6, 2013

Last Update Submitted That Met QC Criteria

June 5, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTDC/DES/113753/2009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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