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Clinical Trials/NCT03414996
NCT03414996CompletedNot Applicable

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

Montreal Heart Institute2 sites in 1 country60 target enrollmentStarted: January 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
Maximal oxygen uptake

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Maximal oxygen uptake

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

Change before and after exercise training

Secondary Outcomes

  • Markers of autonomic nervous system(At baseline and following 12 weeks exercise training intervention)

Investigators

Sponsor
Montreal Heart Institute
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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