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

NCT01432639 | Completed

• 1 other identifier: PTDC/DES/113753/2009
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Coronary Artery Disease

Keywords

Myocardial infarction; Autonomic function; Arterial Stiffness; Endothelial function; Inflammation; Rehabilitation program; Exercise

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

• Arterial Stiffness

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

• Endothelial Function

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

• Cardiorespiratory Fitness

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

• Inflammatory Biomarkers

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

• Anthropometrics

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

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients undergoing the exercise-based cardiac rehabilitation program (intervention)

Other: Exercise-based cardiac rehabilitation program

Control group

NO INTERVENTION

Usual medical care

Interventions

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.

Also known as: Cardiac rehabilitation program

Experimental group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• acute myocardial infarction

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Porto: lead
• Centro Hospitalar de Vila Nova de Gaia/Espinho: collaborator
• Research Center in Physical Activity, Health and Leisure, Portugal: collaborator

Study Sites (1)

Centro Hospitalar de Vila Nova de Gaia/Espinho

Vila Nova de Gaia, 4434-502, Portugal

Location

Related Publications (10)

• 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.

  PMID: 19896741 BACKGROUND

• 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.

  PMID: 12176949 BACKGROUND

• 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.

  PMID: 20861747 BACKGROUND

• 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.

  PMID: 17285225 BACKGROUND

• 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.

  PMID: 16183688 BACKGROUND

• 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.

  PMID: 15177529 BACKGROUND

• 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.

  PMID: 17489343 BACKGROUND

• 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.

  PMID: 15827047 BACKGROUND

• 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.

  PMID: 25602857 DERIVED

• 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.

  PMID: 24766987 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Inflammation; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Jose Oliveira, PhD

  Research Center in Physical Activity, Health and Leisure, Portugal

  STUDY CHAIR

• Fernando Ribeiro, PhD

  Research Center in Physical Activity, Health and Leisure, Portugal

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 13, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 6, 2013

Record last verified: 2013-06

Locations

PT (1)