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

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ClinicalTrials.gov Identifier: NCT03414996
Recruitment Status : Active, not recruiting
First Posted : January 30, 2018
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Montreal Heart Institute

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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Arrhythmia Other: Exercise training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of High-intensity Interval Training on Maximal Oxygen Uptake and Autonomic Nervous System in Patients With Post-acute Coronary Syndrome
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : June 30, 2014
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Maximal oxygen uptake [ Time Frame: At baseline and following 12 weeks exercise training intervention ]
    Change before and after exercise training


Secondary Outcome Measures :
  1. Markers of autonomic nervous system [ Time Frame: At baseline and following 12 weeks exercise training intervention ]
    Change before and after exercise training



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414996


Locations
Canada, Quebec
Cardiovascular prevention and rehabilitation center
Montreal, Quebec, Canada, H1T 1N6
Sponsors and Collaborators
Montreal Heart Institute

Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT03414996     History of Changes
Other Study ID Numbers: MontrealHI EXIT-IV
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Montreal Heart Institute:
Interval training
Autonomic nervous system
Post-acute coronary syndrome

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases