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Coronary Artery DiseaseNCT01432639

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

A study testing Exercise-based cardiac rehabilitation program in people with Coronary Artery Disease, run by Universidade do Porto at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronary Artery Disease
What is being tested?
Exercise-based cardiac rehabilitation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 sitePortugal
Study dates
May 2011to Nov 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • acute myocardial infarction

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Centro Hospitalar de Vila Nova de Gaia/Espinho

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

About this study

Official title: 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.

Being tested
Exercise-based cardiac rehabilitation program
Keywords
Myocardial infarction, Autonomic function, Arterial Stiffness, Endothelial function, Inflammation, Rehabilitation program, Exercise
Medical subject headings
Coronary Artery Disease, Myocardial Infarction, Inflammation, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise-based cardiac rehabilitation programOther

    Also called 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.

Study groups in NCT01432639
Study groupRoleWhat they receive
Experimental groupExperimentalPatients undergoing the exercise-based cardiac rehabilitation program (intervention)
Receives: Other: Exercise-based cardiac rehabilitation program
Control groupNo interventionUsual medical care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from Baseline in Autonomic Function at 8 weeks of Cardiac Rehabilitation Program

Secondary outcomes (9)

  1. Arterial Stiffness

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

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

  2. 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).

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

  3. Cardiorespiratory Fitness

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

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

  4. 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).

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

  5. 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).

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

  6. 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).

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

  7. 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).

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

  8. Daily Physical Activity

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

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

  9. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01432639
Sponsor's protocol ID
PTDC/DES/113753/2009
Status last verified
Jun 2013
First submitted
7 Sep 2011
Last updated
6 Jun 2013
Results posted
No
Data monitoring committee
No

Publications

  • Ribeiro F, Alves AJ, Duarte JA, Oliveira J. Is exercise training an effective therapy targeting endothelial dysfunction and vascular wall inflammation? Int J Cardiol. 2010 Jun 11;141(3):214-21. doi: 10.1016/j.ijcard.2009.09.548. Epub 2009 Nov 6.

    PubMed 19896741

  • Graham LN, Smith PA, Stoker JB, Mackintosh AF, Mary DA. Time course of sympathetic neural hyperactivity after uncomplicated acute myocardial infarction. Circulation. 2002 Aug 13;106(7):793-7. doi: 10.1161/01.cir.0000025610.14665.21.

    PubMed 12176949

  • Laing ST, Gluckman TJ, Weinberg KM, Lahiri MK, Ng J, Goldberger JJ. Autonomic effects of exercise-based cardiac rehabilitation. J Cardiopulm Rehabil Prev. 2011 Mar-Apr;31(2):87-91. doi: 10.1097/HCR.0b013e3181f1fda0.

    PubMed 20861747

  • Sandercock GR, Grocott-Mason R, Brodie DA. Changes in short-term measures of heart rate variability after eight weeks of cardiac rehabilitation. Clin Auton Res. 2007 Feb;17(1):39-45. doi: 10.1007/s10286-007-0392-5. Epub 2007 Feb 6.

    PubMed 17285225

  • Weber T, Auer J, O'rourke MF, Kvas E, Lassnig E, Lamm G, Stark N, Rammer M, Eber B. Increased arterial wave reflections predict severe cardiovascular events in patients undergoing percutaneous coronary interventions. Eur Heart J. 2005 Dec;26(24):2657-63. doi: 10.1093/eurheartj/ehi504. Epub 2005 Sep 23.

    PubMed 16183688

  • Edwards DG, Schofield RS, Magyari PM, Nichols WW, Braith RW. Effect of exercise training on central aortic pressure wave reflection in coronary artery disease. Am J Hypertens. 2004 Jun;17(6):540-3. doi: 10.1016/j.amjhyper.2003.12.001.

    PubMed 15177529

  • Psychari SN, Apostolou TS, Iliodromitis EK, Kourakos P, Liakos G, Kremastinos DT. Inverse relation of C-reactive protein levels to heart rate variability in patients after acute myocardial infarction. Hellenic J Cardiol. 2007 Mar-Apr;48(2):64-71.

    PubMed 17489343

  • Chesterton LJ, Sigrist MK, Bennett T, Taal MW, McIntyre CW. Reduced baroreflex sensitivity is associated with increased vascular calcification and arterial stiffness. Nephrol Dial Transplant. 2005 Jun;20(6):1140-7. doi: 10.1093/ndt/gfh808. Epub 2005 Apr 12.

    PubMed 15827047

  • Oliveira NL, Ribeiro F, Silva G, Alves AJ, Silva N, Guimaraes JT, Teixeira M, Oliveira J. Effect of exercise-based cardiac rehabilitation on arterial stiffness and inflammatory and endothelial dysfunction biomarkers: a randomized controlled trial of myocardial infarction patients. Atherosclerosis. 2015 Mar;239(1):150-7. doi: 10.1016/j.atherosclerosis.2014.12.057. Epub 2015 Jan 14.

    PubMed 25602857

  • Oliveira NL, Ribeiro F, Teixeira M, Campos L, Alves AJ, Silva G, Oliveira J. Effect of 8-week exercise-based cardiac rehabilitation on cardiac autonomic function: A randomized controlled trial in myocardial infarction patients. Am Heart J. 2014 May;167(5):753-61.e3. doi: 10.1016/j.ahj.2014.02.001. Epub 2014 Feb 17.

    PubMed 24766987

Questions about this trial

What is this clinical trial studying?

A study testing Exercise-based cardiac rehabilitation program in people with Coronary Artery Disease, run by Universidade do Porto at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Autonomic Function (time frame: Change from Baseline in Autonomic Function at 8 weeks of Cardiac Rehabilitation Program). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01432639, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2013; AzTrials last refreshed its copy on 1 Nov 2026.

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