High-intensity Interval Training in Patients With Post-acute Coronary Syndrome (EXIT-IV)

September 9, 2022 updated by: Montreal Heart Institute

The Effects of High-intensity Interval Training on Maximal Oxygen Uptake and Autonomic Nervous System in Patients With Post-acute Coronary Syndrome

To date, no studies have evaluated the safety or efficiency (improvement of maximal oxygen uptake [VO2peak]) of a high-intensity interval training (HIIT) program in post-acute coronary syndrome (post-ACS) patients. Heart rate variability (HRV) and recovery (HRR), QT dispersion (QTd) and ventricular arrhythmias are all indices associated with an increased risk of cardiac death. HIIT has been shown to improve these risk markers and be safe in coronary heart disease patients but not yet in post-ACS patients which are considered more at risks.

The aim of this study was to compare a HIIT program to a moderate-intensity continuous exercise training (MICET) program on HRV, HRR, QTd parameters and occurrence of ventricular arrhythmias in post-ACS patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1N6
        • Cardiovascular Prevention and Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females aged ≥ 18 years
  • Acute coronary syndrome within 6 weeks (unstable angina, or non-ST elevation myocardial infarction (NSTEMI), or ST elevation myocardial infarction (STEMI with the presence of 2/3 criteria (i.e. typical chest pain, electrocardiographic ischemic change or elevated troponin T
  • Complete revascularization defined as no major epicardial coronary artery or bypass graft with a residual diameter stenosis >50% and no residual left main stenosis ≥40%
  • Left ventricular ejection fraction >40%
  • Stable doses of medication during the 4 weeks prior to enrolment (STEMI patients must be on a stable dose of beta-blocker)
  • Able to perform a maximal cardiopulmonary exercise test, 7) capacity and willingness to sign informed consent.

Exclusion Criteria:

  • Recent coronary bypass surgery (<6 months)
  • Incomplete revascularisation, left ventricular ejection fraction <40%
  • Significant valvular disease (mitral stenosis, moderate to severe mitral insufficiency, aortic stenosis, or aortic insufficiency)
  • Uncontrolled hypertension (systolic blood pressure/diastolic blood pressure >180/110 mmHg)
  • Significant resting electrocardiogram abnormalities (left bundle branch block, non-specific intraventricular conduction delay, left ventricular hypertrophy, resting ST-segment depression)
  • Chronic atrial fibrillation
  • Pacemaker or implantable cardioverter defibrillator
  • Low functional capacity (<5 basal Metabolic Equivalent of Task [METs])
  • Change of cardiac medications within 4 weeks of enrolment and any contraindication to exercise testing or exercise training.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-intensity interval training
Following 5 min warm-up at 30 % of maximal aerobic power (MAP) obtained at the cardiopulmonary exercise test, patients performed 2 sets of 10 minutes of repeated phases of 15 seconds at 100 % MAP alternating with 15 seconds of passive recovery. The 2 sets were separated by 4 min of passive recovery (no pedalling). Patients performed 5-minutes of recovery period at 30 % MAP after the second set. Total time duration was 34 minutes.
Other: Exercise training
Patients will undergo two weekly exercise training sessions with high-intensity interval training or moderate-intensity continuous exercise training for a period of 12 weeks.
Active Comparator: Moderate-intensity continuous exercise training
Duration was adjusted to match total energy expenditure of the high-intensity interval training session. Following 5 min warm-up at 30 % of maximal aerobic power (MAP), patients performed continuous exercise at 60 % MAP during 24 minutes. Patients performed 5-minutes of recovery period at 30 % MAP after the second set. Total time duration was 34 minutes.
Other: Exercise training
Patients will undergo two weekly exercise training sessions with high-intensity interval training or moderate-intensity continuous exercise training for a period of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal oxygen uptake
Time Frame: At baseline and following 12 weeks exercise training intervention
Change before and after exercise training
At baseline and following 12 weeks exercise training intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Markers of autonomic nervous system
Time Frame: At baseline and following 12 weeks exercise training intervention
Change before and after exercise training
At baseline and following 12 weeks exercise training intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

June 30, 2014

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

January 23, 2018

First Submitted That Met QC Criteria

January 23, 2018

First Posted (Actual)

January 30, 2018

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MontrealHI EXIT-IV

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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