Comparison of Two Exercise Training Modes on Left Myocardial Regional Function After Myocardial Infarction Evaluated by 2D Strain Ultrasound

NCT04190394 | Completed

• 2 other identifiers: NIMAO/2018-03/AD-012019-A01010-57
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• 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 (111)

• Longitudinal diastolic strain on Day 0

  D0

• Longitudinal diastolic strain at Week 8

  Week 8

• Circumferential strain on Day 0

  Day 0

• Circumferential strain at Week 8

  Week 8

• Systolic radial strain on Day 0

  Day 0

Study Arms (2)

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient must have given free informed consent and signed the consent form
• patient must be affiliated to or be covered by a health insurance scheme.
• patient must be an adult aged ≥ 18 to ≤ 75 years old.
• Patient must have had a first episode of myocardial infarction treated via medical treatment or by revascularization like a percutaneous transluminal angioplasty (only if the patient has had complete revascularization) at least 6 weeks previously.

You may not qualify if:

• The patient is participating in another intervention study or has taken part in another interventional study in the past 3 months
• The patient is often under curatorship, tutorship or advisorship.
• It is impossible to give the patient clear information
• The patient refuses to sign the consent form
• The patient is pregnant, about to give birth or breastfeeding
• The patient has a contraindication for retraining
• The patient has a prosthetic heart valve
• The patient has severe valve disorder
• The patient requires cardiac stimulation
• The patient has an automatic implantable defibrillator
• The patient has sinus tachycardia, sinus bradycardia or sinus arrhythmia
• The patient has non-controlled high blood pressure
• The patient has a ventricular ejection fraction \< 45%
• The patient has already participated in a cardiac rehabilitation program less than a year before
• The patient has a relapse of myocardial ischaemia during the study

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

Nîmes University Hospital

Nîmes, Gard, 30000, France

Location

Clinique Lavarin, Centre de Rééducation Cardiaque,1 Rue Mère Térésa,

Avignon, Vaucluse, 84000, France

Location

Related Publications (1)

• 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. 2025 Mar 5:zwaf127. doi: 10.1093/eurjpc/zwaf127. Online ahead of print.

  PMID: 40042823 RESULT

Study Officials

• Arnaud DUPEYRON, Dr.

  CHU de Nîmes (Nîmes University Hospital)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator will not know which group of patients the results are from.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 9, 2019
• Study Start: March 12, 2020
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: March 13, 2026

Record last verified: 2025-12

Locations

FR (2)