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

Primary Purpose

Acute Coronary Syndrome, Arrhythmia

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Exercise training

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Interval training, Autonomic nervous system, Post-acute coronary syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cardiovascular prevention and rehabilitation center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity interval training

Moderate-intensity continuous exercise training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Maximal oxygen uptake

Change before and after exercise training

Secondary Outcome Measures

Markers of autonomic nervous system

Change before and after exercise training

Full Information

NCT ID

NCT03414996

First Posted

January 23, 2018

Last Updated

September 9, 2022

Sponsor

Montreal Heart Institute

1. Study Identification

Unique Protocol Identification Number

NCT03414996

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2011 (Actual)

Primary Completion Date

June 30, 2014 (Actual)

Study Completion Date

December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Montreal Heart Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome, Arrhythmia

Keywords

Interval training, Autonomic nervous system, Post-acute coronary syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-intensity interval training

Arm Type

Experimental

Arm Description

Arm Title

Moderate-intensity continuous exercise training

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Exercise training

Intervention Description

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 Measure Information:

Title

Maximal oxygen uptake

Description

Change before and after exercise training

Time Frame

At baseline and following 12 weeks exercise training intervention

Secondary Outcome Measure Information:

Title

Markers of autonomic nervous system

Description

Change before and after exercise training

Time Frame

At baseline and following 12 weeks exercise training intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Cardiovascular prevention and rehabilitation center

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 1N6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34310883

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.

Results Reference

derived

PubMed Identifier

33096006

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.

Results Reference

derived

PubMed Identifier

31837947

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.

Results Reference

derived

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

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