Clinical trial NCT03821558: Exercise Training in Individuals With Coronary Artery Disease
Official title: Cardiovascular Rehabilitation in Coronary Artery Disease Patients: Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Infarction
Keywords: exercise
interval training
continuous training
endothelial dysfunction
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this controlled trial, patients referred to post-myocardial infarction cardiac rehabilitation will be randomized to either interval or continuous training.

Detailed description: The trial would i) compare the acute effects of each exercise type on selected cardiovascular indicators; ii) compare the chronic effects of each exercise type on selected cardiovascular indicators; iii) provide information on the association between acute and chronic effects of each exercise type; iv) provide insight into possible mechanisms of effectiveness of each exercise type; v) identify the most safe and effective exercise type for patients with coronary artery disease.

Eligibility criteria: Inclusion Criteria:

* myocardium infarction 120 days prior to cardiac rehabilitation

Exclusion Criteria:

* contraindications for exercise training,
* uncontrolled dysrhythmias,
* uncontrolled heart failure (New York Heart Association (NYHA) stage IV),
* intellectual development disorder,
* pregnancy.

Primary outcomes:
measure: Change of flow-mediated dilatation of the brachial artery, measured in %
timeFrame: 3 months
Secondary outcomes:
measure: Change of the arterial stiffness coefficient
timeFrame: 3 months
measure: Change of maximal oxygen uptake during exercise, measured in ml/kg/min
timeFrame: 3 months
measure: Change of the heart rate variability
timeFrame: 3 months
measure: Change of the heart rate recovery
timeFrame: 3 months
measure: Change in health-related quality of life using SF-36 questionnaire, measured in points
timeFrame: 3 months
measure: Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels, measured in ng/l
timeFrame: 3 months
measure: Change in osteopontin and D-dimer levels, measured in microg/l
timeFrame: 3 months
measure: Change in selectin and hsCRP, measured in mg/l
timeFrame: 3 months
measure: Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF, measured in ng/l
timeFrame: 3 months
measure: Change in copeptin levels, measured in pmol/l
timeFrame: 3 months
measure: Change in MR-proADM and MR-proANP, measured in nmol/l
timeFrame: 3 months
measure: Change in homoarginine, ADMA and SDMA levels, measured in micromol/l
timeFrame: 3 months
measure: Change in fibrinogen and Lp(a) levels, measured in mg/dl
timeFrame: 3 months
measure: Change in insuline level, measure in microIU/ml
timeFrame: 3 months
measure: Change in total cholesterol, LDL, HDL, triglycerides and glucose levels, measured in mmol/l
timeFrame: 3 months
measure: Change in overall haemostatic potential
timeFrame: 3 months
Other outcomes:
measure: Change in the flow-mediated dilation during single exercise training session, measured in %
timeFrame: 3 months
measure: Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels during single exercise training session, measured in ng/l
timeFrame: 3 months
measure: Change in selectin and hsCRP during single exercise training session, measured in mg/l
timeFrame: 3 months
measure: Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF levels during single exercise training session, measured in ng/l
timeFrame: 3 months
measure: Change in copeptin levels during single exercise training session, measured in pmol/l
timeFrame: 3 months
measure: Change in homoarginine, ADMA and SDMA levels during single exercise training session, measured in micromol/l
timeFrame: 3 months
measure: Change in fibrinogen level during single exercise training session, measured in mg/dl
timeFrame: 3 months
measure: Change in insuline levels during single exercise training session, measure in microIU/ml
timeFrame: 3 months
measure: Change in osteopontin and D-dimer levels during single exercise training session, measured in microg/l
timeFrame: 3 months
measure: Change in overall haemostatic potential during single exercise training session
timeFrame: 3 months
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Borut Jug, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4.
citation: Liou K, Ho S, Fildes J, Ooi SY. High Intensity Interval versus Moderate Intensity Continuous Training in Patients with Coronary Artery Disease: A Meta-analysis of Physiological and Clinical Parameters. Heart Lung Circ. 2016 Feb;25(2):166-74. doi: 10.1016/j.hlc.2015.06.828. Epub 2015 Jul 22.
citation: Conraads VM, Pattyn N, De Maeyer C, Beckers PJ, Coeckelberghs E, Cornelissen VA, Denollet J, Frederix G, Goetschalckx K, Hoymans VY, Possemiers N, Schepers D, Shivalkar B, Voigt JU, Van Craenenbroeck EM, Vanhees L. Aerobic interval training and continuous training equally improve aerobic exercise capacity in patients with coronary artery disease: the SAINTEX-CAD study. Int J Cardiol. 2015 Jan 20;179:203-10. doi: 10.1016/j.ijcard.2014.10.155. Epub 2014 Oct 25.
citation: Villelabeitia-Jaureguizar K, Vicente-Campos D, Senen AB, Jimenez VH, Garrido-Lestache MEB, Chicharro JL. Effects of high-intensity interval versus continuous exercise training on post-exercise heart rate recovery in coronary heart-disease patients. Int J Cardiol. 2017 Oct 1;244:17-23. doi: 10.1016/j.ijcard.2017.06.067. Epub 2017 Jun 17.
citation: Currie KD, Rosen LM, Millar PJ, McKelvie RS, MacDonald MJ. Heart rate recovery and heart rate variability are unchanged in patients with coronary artery disease following 12 weeks of high-intensity interval and moderate-intensity endurance exercise training. Appl Physiol Nutr Metab. 2013 Jun;38(6):644-50. doi: 10.1139/apnm-2012-0354. Epub 2013 Jan 17.
citation: Novakovic M, Prokselj K, Rajkovic U, Vizintin Cuderman T, Jansa Trontelj K, Fras Z, Jug B. Exercise training in adults with repaired tetralogy of Fallot: A randomized controlled pilot study of continuous versus interval training. Int J Cardiol. 2018 Mar 15;255:37-44. doi: 10.1016/j.ijcard.2017.12.105. Epub 2018 Jan 3.