NCT03821558

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

1.3 years

First QC Date

January 6, 2019

Last Update Submit

December 8, 2021

Conditions

Coronary Artery DiseaseMyocardial Infarction

Keywords

exerciseinterval trainingcontinuous trainingendothelial dysfunction

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (16)

  • 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

    3 months

  • +11 more secondary outcomes

Other Outcomes (10)

  • 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

  • +7 more other outcomes

Study Arms (2)

Interval training group

ACTIVE COMPARATOR

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

Continuous training group

ACTIVE COMPARATOR

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

Interventions

Exercise trainingOTHER

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

Continuous training groupInterval training group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • myocardium infarction 120 days prior to cardiac rehabilitation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

Related Publications (6)

  • 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.

    PMID: 17548726BACKGROUND

  • 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.

    PMID: 26375499BACKGROUND

  • 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.

    PMID: 25464446BACKGROUND

  • 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.

    PMID: 28648356BACKGROUND

  • 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.

    PMID: 23724882BACKGROUND

  • 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.

    PMID: 29338917BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial InfarctionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Borut Jug, MD, PhD

    University Medical Centre Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 6, 2019

First Posted

January 30, 2019

Study Start

March 1, 2019

Primary Completion

June 1, 2020

Study Completion

August 1, 2021

Last Updated

December 10, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)