Comparison of Two Exercise Training Modes on Left Myocard... | NCT04190394

ID	Type	Description	Link
2019-A01010-57	Other Identifier	ANSM ID RCB

Status Module

Oversight Module

Description Module

Brief Summary

Ischemic cardiomyopathy, defined by a deficiency in oxygenation of the myocardium due to a narrowing of the coronary arteries, is a major problem for public health. Medicinally-treated or re-vascularized cardiovascular rehabilitation following myocardial infarction has shown undeniable benefits in decreasing the overall mortality rate (13-26%), cardiovascular mortality (26-36%) and morbidity, by controlling cardiovascular risk factors and improving tolerance to effort and consequently improving the quality of life. Since the integration of physical exercise into the rehabilitation programs of patients suffering from coronary disease in the mid-90s, and throughout the following decade, the exercise training program has mainly relied on moderately intense continuous exercises (CONT) the aim of which is to improve the aerobic capacity. These efforts typically consist of performing a submaximal exercise with an intensity of 50 to 80% of the maximum capacity for effort (established according to studies depending on the maximum or reserve heart rate or even peak power, measured when performing a first test, then a progressive and maximum test), and a constant duration (about 20 to 60 minutes). In the 2000s, under the aegis of Scandinavian teams, the intermittent mode (IT) appeared, characterized by alternating high intensity efforts of a short duration with active recuperation phases (Rognmo et al., 2004). Superiority of the IT mode over the CONT mode is generally observed on aerobic capacity for effort, usually gauged via the maximal oxygen consumption peak measured during a graded and maximum effort test. An important methodological bias in the comparison of the two modalities, within meta-analyses or even in the same randomized controlled trial, is the absence of control/pairing on the overall volume of training. At the present time, and to the best of our knowledge, there have been no studies to compare the effects of CONT versus IT modes on the systolic or diastolic function of the myocardial region by 2D-strain following myocardial infarction. The aim of our study was to compare the outcomes of 2D strain scans upon inclusion and after 8 weeks of cardiovascular physiotherapy for 2 groups of patients benefiting from a CONT or IT program.

Detailed Description

This is a bi-centric randomised comparative superiority trial, blinded to the evaluator for 2 parallel groups (interventional intermittent training group "IT" vs a continuous training control group "CONT") with a 1:1 ratio.

Patients admitted for care at the cardiology departments of Nîmes University Hospital and the cardiology department of Avignon hospital for a first myocardial infarction dating back to less than 6 weeks will be pre-selected. The patients will receive both written and oral information about the study.

Patients are then referred to the Physical Medicine and Cardiac Rehabilitation departments at Nîmes University Hospital for the Nîmes site and the Lavarin Cardio Rehabilitation Center for the Avignon site for the inclusion visit at which the information about the study is given. Patients will be included in the study after signing a consent form.

The investigators then proceed with a maximal aerobic exercise test to evaluate cardiovascular endurance capacities and the suitability of the cardiovascular training program. Cardiac ultrasound is also performed, questionnaires about the quality of life are administered and biological doses are measured.

Then a stratified randomisation on the patient's age and sex will be performed to assign the subject either to the "IT intermittent training group" group, the experimental group, or to the "CONT continuous training" group, the control group which corresponds to the general care usually given.

Comparison of these two groups constitutes the methodological framework for this research. In the "IT intermittent training group (the experimental group), the patient benefits from a retraining program according to intermittent mode for 8 weeks, with three 45-minute sessions per week.

In the "CONT continuous training" group (the control group), the patient benefits from a retraining program according to the continuous mode for 8 weeks, with three 40-minute sessions per week.

At the end of the retraining program, at 8 weeks, an exercise test and a 2D Strain scan are performed, biological doses are taken and quality of life questionnaires are handed out.

Each patient will be followed 2 months after inclusion. The duration of inclusion period will be 18 months. The total duration of the test will be 24 months.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients following the CONT program	No Intervention	In the " CONT continuous training" group, the control group, the patient benefits from a retraining program according to the continuous mode (see details in section 3.4) for 8 weeks, with three 40-minute sessions per week.
Patients following the IT program	Experimental	In the "IT intermittent training group", group, (the experimental group), the patient benefits from a retraining program according to the intermittent mode (see details in section 3.4) for 8 weeks, with three 45-minute sessions per week.	Other: Intermittent retraining program.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intermittent retraining program.	Other	Patient benefits from an intermittent retraining program for 8 weeks, with three 45-minute sessions per week.	Patients following the IT program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Longitudinal systolic strain on Day 0.	All patients, whatever group they have been assigned to, will undergo a 2D Strain scan at the inclusion visit, before starting continuous (CONT) or intermittent (IT) cardiovascular rehabilitation.The overall longitudinal systolic strain (s-1) of the left ventricle will be measured (%) by echocardiography.	Day 0
Longitudinal systolic strain at Week 8.	All patients whatever group they have been assigned to will undergo a 2D Strain scan after undergoing 8 weeks continuous (CONT) or intermittent (IT) of cardiovascular physiotherapy.The overall longitudinal strain (s-1) of the left ventricle will be measured (%) by echocardiography.	Week 8

Secondary Outcomes

Measure	Description	Time Frame
Longitudinal diastolic strain on Day 0	Longitudinal diastolic strain (s-1) will be measured by echocardiography before undergoing CONT or IT cardiovascular rehabilitation.	D0
Longitudinal diastolic strain at Week 8

Eligibility Module

Name	Affiliation	Role
Arnaud DUPEYRON, Dr.	CHU de Nîmes (Nîmes University Hospital)	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Nîmes University Hospital		Nîmes	Gard	30000	France
Clinique Lavarin, Centre de Rééducation Cardiaque,1 Rue Mère Térésa,

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40042823	Result	Obert P, Nottin S, Belvisi C, Robert C, Miramont V, de France C, Carlioz R, Landrier JF, Poirier P, Dupeyron A. A comprehensive analysis of the impact of high-intensity interval vs. moderate-intensity continuous training on global and regional myocardial function in patients early after acute myocardial infarction: the STRAICT randomized controlled trial. Eur J Prev Cardiol. 2026 Apr 22;33(6):883-894. doi: 10.1093/eurjpc/zwaf127.