Clinical trial NCT03414996: High-intensity Interval Training in Patients With Post-acute Coronary Syndrome
Official title: The Effects of High-intensity Interval Training on Maximal Oxygen Uptake and Autonomic Nervous System in Patients With Post-acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Arrhythmia
Keywords: Interval training
Autonomic nervous system
Post-acute coronary syndrome
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximal oxygen uptake
timeFrame: At baseline and following 12 weeks exercise training intervention
Secondary outcomes:
measure: Markers of autonomic nervous system
timeFrame: At baseline and following 12 weeks exercise training intervention
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Cardiovascular prevention and rehabilitation center
state: Quebec
Study officials:
References:
citation: Trachsel LD, David LP, Gayda M, Boidin M, Lalonge J, Juneau M, Nigam A, Henri C. Impact of aerobic training periodisation on global and regional right ventricular strain in coronary heart disease. Appl Physiol Nutr Metab. 2021 Dec;46(12):1502-1509. doi: 10.1139/apnm-2021-0055. Epub 2021 Jul 26.
citation: Trachsel LD, Boidin M, Henri C, Fortier A, Lalonge J, Juneau M, Nigam A, Gayda M. Women and men with coronary heart disease respond similarly to different aerobic exercise training modalities: a pooled analysis of prospective randomized trials. Appl Physiol Nutr Metab. 2021 May;46(5):417-425. doi: 10.1139/apnm-2020-0650. Epub 2020 Oct 23.
citation: Trachsel LD, Nigam A, Fortier A, Lalonge J, Juneau M, Gayda M. Moderate-intensity continuous exercise is superior to high-intensity interval training in the proportion of VO2peak responders after ACS. Rev Esp Cardiol (Engl Ed). 2020 Sep;73(9):725-733. doi: 10.1016/j.rec.2019.09.013. Epub 2019 Dec 16. English, Spanish.