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Completed

NCT Number: NCT03414996

High-intensity Interval Training 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular prevention and rehabilitation center

Montreal, Quebec, H1T 1N6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise training

Other

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.

Primary outcomes

  1. Maximal oxygen uptake

    Time frame: At baseline and following 12 weeks exercise training intervention

    Change before and after exercise training

Secondary outcomes

  1. Markers of autonomic nervous system

    Time frame: At baseline and following 12 weeks exercise training intervention

    Change before and after exercise training

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Official study title

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

Acronym: EXIT-IV

Important dates

Study start
2011
Primary completion
2014
Study completion
2021
First posted
Jan 30, 2018
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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