Clinical trial NCT01432639: Effects of Exercise Training on Endothelial Function, Inflammation, Arterial Stiffness and Autonomic Function in CAD
Official title: Effects of Exercise Training on Endothelial Function, Inflammation, Arterial Stiffness and Autonomic Function in Coronary Artery Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Myocardial infarction
Autonomic function
Arterial Stiffness
Endothelial function
Inflammation
Rehabilitation program
Exercise
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar de Vila Nova de Gaia/Espinho
name: Research Center in Physical Activity, Health and Leisure, Portugal
First posted: 2011-09-13
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Autonomic Function
timeFrame: Change from Baseline in Autonomic Function at 8 weeks of Cardiac Rehabilitation Program
Secondary outcomes:
measure: Arterial Stiffness
timeFrame: Change from Baseline in Arterial Stiffness at 8 weeks of Cardiac Rehabilitation Program
measure: Endothelial Function
timeFrame: Change from Baseline in Endothelial Function at 8 weeks of Cardiac Rehabilitation Program
measure: Cardiorespiratory Fitness
timeFrame: Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Program
measure: Inflammatory Biomarkers
timeFrame: Change from Baseline in Inflammatory Biomarkers at 8 weeks of Cardiac Rehabilitation Program
measure: Anthropometrics
timeFrame: Change from Baseline in Anthropometrics at 8 weeks of Cardiac Rehabilitation Program
measure: Blood Pressure
timeFrame: Change from Baseline in Blood Pressure at 8 weeks of Cardiac Rehabilitation Program
measure: Dietary Intake
timeFrame: Change from Baseline in Dietary Intake at 8 weeks of Cardiac Rehabilitation Program
measure: Daily Physical Activity
timeFrame: Change from Baseline in Daily Physical Activity at 8 weeks of Cardiac Rehabilitation Program
measure: Biochemical Parameters
timeFrame: Change from Baseline in Biochemical Parameters at 8 weeks of Cardiac Rehabilitation Program
Other outcomes:
Locations:
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho
Study officials:
affiliation: Research Center in Physical Activity, Health and Leisure, Portugal
name: Jose Oliveira, PhD
role: STUDY_CHAIR
affiliation: Research Center in Physical Activity, Health and Leisure, Portugal
name: Fernando Ribeiro, PhD
role: STUDY_DIRECTOR
affiliation: Research Center in Physical Activity, Health and Leisure, Portugal
name: Nórton L Oliveira, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Hospitalar de Vila Nova de Gaia/Espinho
name: Madalena Teixeira, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.