Exercise Training in Individuals With Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— ReKoBo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03821558
• Other study ID #: UKCLRehab0012019
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: December 2021
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: August 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (6)

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. — View 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. — View 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. Review. — View Citation

Novakovic M, Prokšelj K, Rajkovic U, Vižintin Cuderman T, Janša 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. — View Citation

Villelabeitia-Jaureguizar K, Vicente-Campos D, Senen AB, Jiménez 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. — View Citation

Wisløff U, Støylen A, Loennechen JP, Bruvold M, Rognmo Ø, Haram PM, Tjønna AE, Helgerud J, Slørdahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen Ø, 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. Epub 2007 Jun 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the flow-mediated dilation during single exercise training session, measured in %		3 months
Other	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
Other	Change in selectin and hsCRP during single exercise training session, measured in mg/l		3 months
Other	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
Other	Change in copeptin levels during single exercise training session, measured in pmol/l		3 months
Other	Change in homoarginine, ADMA and SDMA levels during single exercise training session, measured in micromol/l		3 months
Other	Change in fibrinogen level during single exercise training session, measured in mg/dl		3 months
Other	Change in insuline levels during single exercise training session, measure in microIU/ml		3 months
Other	Change in osteopontin and D-dimer levels during single exercise training session, measured in microg/l		3 months
Other	Change in overall haemostatic potential during single exercise training session		3 months
Primary	Change of flow-mediated dilatation of the brachial artery, measured in %		3 months
Secondary	Change of the arterial stiffness coefficient		3 months
Secondary	Change of maximal oxygen uptake during exercise, measured in ml/kg/min		3 months
Secondary	Change of the heart rate variability		3 months
Secondary	Change of the heart rate recovery		3 months
Secondary	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
Secondary	Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels, measured in ng/l		3 months
Secondary	Change in osteopontin and D-dimer levels, measured in microg/l		3 months
Secondary	Change in selectin and hsCRP, measured in mg/l		3 months
Secondary	Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF, measured in ng/l		3 months
Secondary	Change in copeptin levels, measured in pmol/l		3 months
Secondary	Change in MR-proADM and MR-proANP, measured in nmol/l		3 months
Secondary	Change in homoarginine, ADMA and SDMA levels, measured in micromol/l		3 months
Secondary	Change in fibrinogen and Lp(a) levels, measured in mg/dl		3 months
Secondary	Change in insuline level, measure in microIU/ml		3 months
Secondary	Change in total cholesterol, LDL, HDL, triglycerides and glucose levels, measured in mmol/l		3 months
Secondary	Change in overall haemostatic potential		3 months