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Exercise Training in Individuals With Coronary Artery Disease (ReKoBo)

Primary Purpose

Coronary Artery Disease, Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Exercise training
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring exercise, interval training, continuous training, endothelial dysfunction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Medical Centre Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Interval training group

Continuous training group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Change of flow-mediated dilatation of the brachial artery, measured in %

Secondary Outcome Measures

Change of the arterial stiffness coefficient
Change of maximal oxygen uptake during exercise, measured in ml/kg/min
Change of the heart rate variability
Change of the heart rate recovery
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)
Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels, measured in ng/l
Change in osteopontin and D-dimer levels, measured in microg/l
Change in selectin and hsCRP, measured in mg/l
Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF, measured in ng/l
Change in copeptin levels, measured in pmol/l
Change in MR-proADM and MR-proANP, measured in nmol/l
Change in homoarginine, ADMA and SDMA levels, measured in micromol/l
Change in fibrinogen and Lp(a) levels, measured in mg/dl
Change in insuline level, measure in microIU/ml
Change in total cholesterol, LDL, HDL, triglycerides and glucose levels, measured in mmol/l
Change in overall haemostatic potential

Full Information

First Posted
January 6, 2019
Last Updated
December 8, 2021
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT03821558
Brief Title
Exercise Training in Individuals With Coronary Artery Disease
Acronym
ReKoBo
Official Title
Cardiovascular Rehabilitation in Coronary Artery Disease Patients: Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Myocardial Infarction
Keywords
exercise, interval training, continuous training, endothelial dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interval training group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Continuous training group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.
Primary Outcome Measure Information:
Title
Change of flow-mediated dilatation of the brachial artery, measured in %
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change of the arterial stiffness coefficient
Time Frame
3 months
Title
Change of maximal oxygen uptake during exercise, measured in ml/kg/min
Time Frame
3 months
Title
Change of the heart rate variability
Time Frame
3 months
Title
Change of the heart rate recovery
Time Frame
3 months
Title
Change in health-related quality of life using SF-36 questionnaire, measured in points
Description
It is a self-administered questionnaire comprising 36 items measuring eight dimensions and two subscales (physical and mental)
Time Frame
3 months
Title
Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels, measured in ng/l
Time Frame
3 months
Title
Change in osteopontin and D-dimer levels, measured in microg/l
Time Frame
3 months
Title
Change in selectin and hsCRP, measured in mg/l
Time Frame
3 months
Title
Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF, measured in ng/l
Time Frame
3 months
Title
Change in copeptin levels, measured in pmol/l
Time Frame
3 months
Title
Change in MR-proADM and MR-proANP, measured in nmol/l
Time Frame
3 months
Title
Change in homoarginine, ADMA and SDMA levels, measured in micromol/l
Time Frame
3 months
Title
Change in fibrinogen and Lp(a) levels, measured in mg/dl
Time Frame
3 months
Title
Change in insuline level, measure in microIU/ml
Time Frame
3 months
Title
Change in total cholesterol, LDL, HDL, triglycerides and glucose levels, measured in mmol/l
Time Frame
3 months
Title
Change in overall haemostatic potential
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Change in the flow-mediated dilation during single exercise training session, measured in %
Time Frame
3 months
Title
Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels during single exercise training session, measured in ng/l
Time Frame
3 months
Title
Change in selectin and hsCRP during single exercise training session, measured in mg/l
Time Frame
3 months
Title
Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF levels during single exercise training session, measured in ng/l
Time Frame
3 months
Title
Change in copeptin levels during single exercise training session, measured in pmol/l
Time Frame
3 months
Title
Change in homoarginine, ADMA and SDMA levels during single exercise training session, measured in micromol/l
Time Frame
3 months
Title
Change in fibrinogen level during single exercise training session, measured in mg/dl
Time Frame
3 months
Title
Change in insuline levels during single exercise training session, measure in microIU/ml
Time Frame
3 months
Title
Change in osteopontin and D-dimer levels during single exercise training session, measured in microg/l
Time Frame
3 months
Title
Change in overall haemostatic potential during single exercise training session
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borut Jug, MD, PhD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17548726
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.
Results Reference
background
PubMed Identifier
26375499
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.
Results Reference
background
PubMed Identifier
25464446
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.
Results Reference
background
PubMed Identifier
28648356
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.
Results Reference
background
PubMed Identifier
23724882
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.
Results Reference
background
PubMed Identifier
29338917
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.
Results Reference
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Exercise Training in Individuals With Coronary Artery Disease

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