NCT03414996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

3.5 years

First QC Date

January 23, 2018

Last Update Submit

September 9, 2022

Conditions

Acute Coronary SyndromeArrhythmia

Keywords

Interval trainingAutonomic nervous systemPost-acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen uptake

    Change before and after exercise training

    At baseline and following 12 weeks exercise training intervention

Secondary Outcomes (1)

  • Markers of autonomic nervous system

    At baseline and following 12 weeks exercise training intervention

Study Arms (2)

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.

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.

Other: Exercise training

Interventions

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.

High-intensity interval trainingModerate-intensity continuous exercise training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular prevention and rehabilitation center

Montreal, Quebec, H1T 1N6, Canada

Location

Related Publications (3)

  • 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.

    PMID: 34310883DERIVED

  • 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.

    PMID: 33096006DERIVED

  • 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.

    PMID: 31837947DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeArrhythmias, Cardiac

Interventions

Exercise

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2018

First Posted

January 30, 2018

Study Start

January 1, 2011

Primary Completion

June 30, 2014

Study Completion

December 30, 2021

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)