High-intensity Interval Training in Patients With Post-acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— EXIT-IV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414996
• Other study ID #: MontrealHI EXIT-IV
• Status: Completed
• Phase: N/A
• Start date: January 1, 2011
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2022
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2021
• Est. primary completion date: June 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Arrhythmia
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Canada	Cardiovascular prevention and rehabilitation center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal oxygen uptake	Change before and after exercise training	At baseline and following 12 weeks exercise training intervention
Secondary	Markers of autonomic nervous system	Change before and after exercise training	At baseline and following 12 weeks exercise training intervention