Acute Coronary SyndromeEXIT-IVNCT03414996
High-intensity Interval Training in Patients With Post-acute Coronary Syndrome
A study testing Exercise training in people with Acute Coronary Syndrome and Arrhythmia, run by Montreal Heart Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Arrhythmia
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2011to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cardiovascular prevention and rehabilitation center
Montreal, Quebec, H1T 1N6
About this study
Official title: The Effects of High-intensity Interval Training on Maximal Oxygen Uptake and Autonomic Nervous System in Patients With Post-acute Coronary Syndrome
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.
- Conditions
- Acute Coronary Syndrome, Arrhythmia
- Being tested
- Exercise training
- Keywords
- Interval training, Autonomic nervous system, Post-acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training | Experimental | 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. Receives: Other: Exercise training |
| Moderate-intensity continuous exercise training | Active comparator | 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. Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake
Change before and after exercise training
Measured: At baseline and following 12 weeks exercise training intervention
Secondary outcomes (1)
Markers of autonomic nervous system
Change before and after exercise training
Measured: At baseline and following 12 weeks exercise training intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Jan 2011
- Primary completion30 Jun 2014
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414996
- Sponsor's protocol ID
- MontrealHI EXIT-IV
- Acronym
- EXIT-IV
- Status last verified
- Sep 2022
- First submitted
- 23 Jan 2018
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gayda M, Trachsel LD, Besnier F, Boidin M, Lalonge J, Bherer L, Juneau M, Lepretre PM, Nigam A. Effects of different exercise training programs on post-exercise [Formula: see text]O2 recovery responses in patients with coronary heart disease. Eur J Appl Physiol. 2026 Jun;126(6):3393-3406. doi: 10.1007/s00421-026-06146-4. Epub 2026 Feb 25.
PubMed 41739167Trachsel 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.
PubMed 34310883Trachsel 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.
PubMed 33096006Trachsel 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.
PubMed 31837947
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High-intensity Interval Training on Maximal Oxygen Uptake and Autonomic Nervous System in Patients With Post-acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03414996
- Acronym / sponsor ID
- EXIT-IV / MontrealHI EXIT-IV
- Conditions
- Acute Coronary Syndrome, Arrhythmia
- Keywords
- Interval training, Autonomic nervous system, Post-acute coronary syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Other: Exercise trainingFollowing 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. |
| Moderate-intensity continuous exercise training | Active comparator | Other: Exercise trainingDuration 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingPatients will undergo two weekly exercise training sessions with high-intensity interval training or moderate-intensity continuous exercise training for a period of 12 weeks. | Other | High-intensity interval training, Moderate-intensity continuous exercise training |
Primary outcome
Maximal oxygen uptake
Time frame: At baseline and following 12 weeks exercise training intervention
Change before and after exercise training
1 secondary outcome
Markers of autonomic nervous system
Time frame: At baseline and following 12 weeks exercise training intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Derived from this study: PubMed 41739167Gayda M, Trachsel LD, Besnier F, Boidin M, Lalonge J, Bherer L, Juneau M, Lepretre PM, Nigam A. Effects of different exercise training programs on post-exercise [Formula: see text]O2 recovery responses in patients with coronary heart disease. Eur J Appl Physiol. 2026 Jun;126(6):3393-3406. doi: 10.1007/s00421-026-06146-4. Epub 2026 Feb 25.
- Derived from this study: PubMed 34310883Trachsel 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.
- Derived from this study: PubMed 33096006Trachsel 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.
- Derived from this study: PubMed 31837947Trachsel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Acute Coronary Syndrome and Arrhythmia, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen uptake (time frame: At baseline and following 12 weeks exercise training intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03414996, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.