Exercise Training in Individuals With Coronary Artery Disease (ReKoBo)

Cardiovascular Rehabilitation in Coronary Artery Disease Patients: Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters

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

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Coronary Artery Disease
• Intervention / Treatment: Other: Exercise 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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia
    • University Medical Centre Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interval training group; Patients to be randomized to the 'interval training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo interval exercise series composed of high-intensity intervals (80-90% of peak exercise performance) and low-intensity intervals (60-70% of peak exercise performance).	Other: Exercise training; Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.
Active Comparator: Continuous training group; Patients to be randomized to the 'continuous training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo moderate continuous exercise training at 75% of peak exercise performance.	Other: Exercise training; Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of flow-mediated dilatation of the brachial artery, measured in %	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the arterial stiffness coefficient		3 months
Change of maximal oxygen uptake during exercise, measured in ml/kg/min		3 months
Change of the heart rate variability		3 months
Change of the heart rate recovery		3 months
Change in health-related quality of life using SF-36 questionnaire, measured in points	It is a self-administered questionnaire comprising 36 items measuring eight dimensions and two subscales (physical and mental)	3 months
Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels, measured in ng/l		3 months
Change in osteopontin and D-dimer levels, measured in microg/l		3 months
Change in selectin and hsCRP, measured in mg/l		3 months
Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF, measured in ng/l		3 months
Change in copeptin levels, measured in pmol/l		3 months
Change in MR-proADM and MR-proANP, measured in nmol/l		3 months
Change in homoarginine, ADMA and SDMA levels, measured in micromol/l		3 months
Change in fibrinogen and Lp(a) levels, measured in mg/dl		3 months
Change in insuline level, measure in microIU/ml		3 months
Change in total cholesterol, LDL, HDL, triglycerides and glucose levels, measured in mmol/l		3 months
Change in overall haemostatic potential		3 months

Other Outcome Measures

Outcome Measure	Time Frame
Change in the flow-mediated dilation during single exercise training session, measured in %	3 months
Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels during single exercise training session, measured in ng/l	3 months
Change in selectin and hsCRP during single exercise training session, measured in mg/l	3 months
Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF levels during single exercise training session, measured in ng/l	3 months
Change in copeptin levels during single exercise training session, measured in pmol/l	3 months
Change in homoarginine, ADMA and SDMA levels during single exercise training session, measured in micromol/l	3 months
Change in fibrinogen level during single exercise training session, measured in mg/dl	3 months
Change in insuline levels during single exercise training session, measure in microIU/ml	3 months
Change in osteopontin and D-dimer levels during single exercise training session, measured in microg/l	3 months
Change in overall haemostatic potential during single exercise training session	3 months

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Principal Investigator: Borut Jug, MD, PhD, University Medical Centre Ljubljana

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: January 6, 2019
• First Submitted That Met QC Criteria: January 27, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: exercise; endothelial dysfunction; interval training; continuous training
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: UKCLRehab0012019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No