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Coronary Artery DiseaseReKoBoNCT03821558

Exercise Training in Individuals With Coronary Artery Disease

A study testing Exercise training in people with Coronary Artery Disease and Myocardial Infarction, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
What is being tested?
Exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
1 siteSlovenia
Study dates
1 Mar 2019to 1 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • myocardium infarction 120 days prior to cardiac rehabilitation

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

  • University Medical Centre Ljubljana

    Ljubljana

Other trials in Slovenia

About this study

Official title: 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.

Read the 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.

Being tested
Exercise training
Keywords
exercise, interval training, continuous training, endothelial dysfunction
Medical subject headings
Coronary Artery Disease, Myocardial Infarction, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise trainingOther

    Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.

Study groups in NCT03821558
Study groupRoleWhat they receive
Interval training groupActive comparatorPatients 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).
Receives: Other: Exercise training
Continuous training groupActive comparatorPatients 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.
Receives: Other: Exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months

Secondary outcomes (16)

  1. Change of the arterial stiffness coefficient

    Measured: 3 months

  2. Change of maximal oxygen uptake during exercise, measured in ml/kg/min

    Measured: 3 months

  3. Change of the heart rate variability

    Measured: 3 months

  4. Change of the heart rate recovery

    Measured: 3 months

  5. 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)

    Measured: 3 months

  6. Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels, measured in ng/l

    Measured: 3 months

  7. Change in osteopontin and D-dimer levels, measured in microg/l

    Measured: 3 months

  8. Change in selectin and hsCRP, measured in mg/l

    Measured: 3 months

  9. Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF, measured in ng/l

    Measured: 3 months

  10. Change in copeptin levels, measured in pmol/l

    Measured: 3 months

  11. Change in MR-proADM and MR-proANP, measured in nmol/l

    Measured: 3 months

  12. Change in homoarginine, ADMA and SDMA levels, measured in micromol/l

    Measured: 3 months

  13. Change in fibrinogen and Lp(a) levels, measured in mg/dl

    Measured: 3 months

  14. Change in insuline level, measure in microIU/ml

    Measured: 3 months

  15. Change in total cholesterol, LDL, HDL, triglycerides and glucose levels, measured in mmol/l

    Measured: 3 months

  16. Change in overall haemostatic potential

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2019
  2. Study start1 Mar 2019
  3. Primary completion1 Jun 2020
  4. Study completion1 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03821558
Sponsor's protocol ID
UKCLRehab0012019
Acronym
ReKoBo
Status last verified
Dec 2021
First submitted
6 Jan 2019
Last updated
10 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 17548726

  • 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.

    PubMed 26375499

  • 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.

    PubMed 25464446

  • 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.

    PubMed 28648356

  • 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.

    PubMed 23724882

  • 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.

    PubMed 29338917

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training in people with Coronary Artery Disease and Myocardial Infarction, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of flow-mediated dilatation of the brachial artery, measured in % (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03821558, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.

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