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NCT Number: NCT04190394

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

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.

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Key information

Conditions

Ischemic Cardiomyopathy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nîmes University Hospital, Nîmes, Gard, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • The patient is participating in another intervention study or has taken part in another interventional study in the past 3 months
  • The patient is in an exclusion period determined by a previous study
  • 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

Treatment and study plan

Intermittent retraining program.

Other

Patient benefits from an intermittent retraining program for 8 weeks, with three 45-minute sessions per week.

Primary outcomes

  1. Longitudinal systolic strain on Day 0.

    Time frame: 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.

  2. Longitudinal systolic strain at Week 8.

    Time frame: 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.

Secondary outcomes

  1. Longitudinal diastolic strain on Day 0

    Time frame: D0

    Longitudinal diastolic strain (s-1) will be measured by echocardiography before undergoing CONT or IT cardiovascular rehabilitation.

  2. Longitudinal diastolic strain at Week 8

    Time frame: Week 8

    Longitudinal diastolic strain (s-1) will be measured by echocardiography after 8 weeks of CONT or IT cardiovascular rehabilitation.

  3. Circumferential strain on Day 0

    Time frame: Day 0

    Circumferential strain (s-1) will be measured by echocardiography before beginning CONT or IT cardiovascular rehabilitation.

  4. Circumferential strain at Week 8

    Time frame: Week 8

    Circumferential strain (s-1) will be measured by echocardiography after undergoing CONT or IT cardiovascular rehabilitation.

  5. Systolic radial strain on Day 0

    Time frame: Day 0

    Systolic radial strain (%) will be measured by echocardiography before beginning CONT or IT cardiovascular rehabilitation.

  6. Systolic radial strain at Week 8

    Time frame: Week 8

    Systolic radial strain (%) will be measured by echocardiography after undergoing CONT or IT cardiovascular rehabilitation.

  7. Diastolic radial strain on Day 0

    Time frame: Day 0

    Diastolic radial strain (s-1) will be measured by echocardiography before beginning CONT or IT cardiovascular rehabilitation.

  8. Diastolic radial strain at Week 8

    Time frame: Week 8

    Diastolic radial strain (S-1) will be measured by echocardiography after undergoing CONT or IT cardiovascular rehabilitation.

  9. Systolic circumferential strain on Day 0

    Time frame: D0

    Systolic circumferential strain (s-1) will be measured before undergoing CONT or IT cardiovascular rehabilitation.

  10. Systolic circumferential strain at Week 8

    Time frame: Week 8

    Systolic circumferential radial strain (s-1) will be measured after undergoing 8 weeks of CONT or IT cardiovascular rehabilitation.

  11. Diastolic circumferential strain on Day 0

    Time frame: Day 0

    Diastolic circumferential strain (s-1) will be measured before undergoing CONT or IT cardiovascular rehabilitation.

  12. Diastolic circumferential strain at Week 8

    Time frame: Week 8

    Diastolic circumferential strain (s-1) will be measured after undergoing CONT or IT cardiovascular rehabilitation.

  13. Apical rotation on Day 0

    Time frame: Day 0

    Apical rotation (°) will be measured before undergoing CONT or IT cardiovascular rehabilitation.

  14. Apical rotation at Week 8

    Time frame: Week 8

    Apical rotation (°) will be measured after undergoing 8 weeks of CONT or IT cardiovascular rehabilitation.

  15. Basal rotation on Day 0

    Time frame: Day 0

    Basal rotation (°) will be measured before undergoing CONT or IT cardiovascular rehabilitation.

  16. Basal rotation at Week 8

    Time frame: Week 8

    Basal rotation (°) will be measured after undergoing 8 weeks of CONT or IT cardiovascular rehabilitation.

  17. Ventricular torsion on Day 0

    Time frame: Day 0

    Ventricular torsion (°) will be measured before undergoing CONT or IT cardiovascular rehabilitation.

  18. Ventricular torsion at Week 8

    Time frame: Week 8

    Ventricular torsion (°) will be measured after undergoing 8 weeks of CONT or IT cardiovascular rehabilitation.

  19. Intraventricular asynchrony on Day 0

    Time frame: Day 0

    Intraventricular asynchrony (ms) will be measured before undergoing CONT or IT cardiovascular rehabilitation.

  20. Intraventricular asynchrony at Week 8

    Time frame: Week 8

    Intraventricular asynchrony (ms) will be measured after undergoing 8 weeks of CONT or IT cardiovascular rehabilitation.

  21. Cardiac morphology : Telesystolic volume on Day 0

    Time frame: D0

    Telesystolic volume wil be measured (mL) before starting cardiac rehabilitation.

  22. Cardiac morphology : Telesystolic volume at Week 8

    Time frame: Week 8

    Telesystolic volume wil be measured (mL) after cardiac rehabilitation.

  23. Cardiac morphology : Telediastolic volume on Day 0

    Time frame: Day 0

    Telediastolic volume will be measured (mL) before starting cardiac rehabilitation.

  24. Cardiac morphology : Telediastolic volume at Week 8

    Time frame: Week 8

    Telediastolic volume will be measured (mL) after cardiac rehabilitation.

  25. Cardiac morphology : Left ventricle mass on Day 0

    Time frame: Day 0

    Left ventricle mass will be measured (g/m²) before starting cardiac rehabilitation.

  26. Cardiac morphology : Left ventricle mass at Week 8

    Time frame: Week 8

    Left ventricle mass will be measured (g/m²) after cardiac rehabilitation.

  27. Cardiac morphology : FEVG at Day 0

    Time frame: Day 0

    FEVG will be measured (%) before cardiac rehabilitation.

  28. Cardiac morphology : FEVG at Week 8

    Time frame: Week 8

    FEVG will be measured (%) after cardiac rehabilitation.

  29. Cardiac morphology : S' wave on Day 0

    Time frame: Day 0

    S' wave will be measured (%) before cardiac rehabilitation.

  30. Cardiac morphology : S' wave at Week 8

    Time frame: Week 8

    S' wave will be measured (%) after cardiac rehabilitation.

  31. Cardiac morphology : E/A ratio on Day 0

    Time frame: Day 0

    E/A ratio will be measured before cardiac rehabilitation.

  32. Cardiac morphology : E/A ratio at Week 8

    Time frame: Week 8

    E/A ratio will be measured after cardiac rehabilitation.

  33. Cardiac morphology : E' wave at Day 0

    Time frame: Day 0

    E' wave will be measured cm/s) before cardiac rehabilitation.

  34. Cardiac morphology : E' wave at Week 8

    Time frame: Week 8

    E' wave will be measured (cm/s) after cardiac rehabilitation.

  35. Cardiac morphology : A' wave on Day 0

    Time frame: Day 0

    A' wave will be measured (cm/s) before cardiac rehabilitation.

  36. Cardiac morphology : A' wave at Week 8

    Time frame: Week 8

    A' wave will be measured (cm/s) after cardiac rehabilitation.

  37. Cardiac morphology : E/E' ratio on Day 0

    Time frame: Day 0

    E/E' ratio will be measured before cardiac rehabilitation.

  38. Cardiac morphology : E/E' ratio at Week 8

    Time frame: Week 8

    E/E' ratio will be measured after cardiac rehabilitation.

  39. Cardiac morphology : Systolic ejection volume on Day 0

    Time frame: Day 0

    Systolic ejection volume will be measured before cardiac rehabilitation.

  40. Cardiac morphology : Systolic ejection volume at Week 8

    Time frame: Week 8

    Systolic ejection volume will be measured after cardiac rehabilitation.

  41. Aerobic capacity: VO2max on Day 0

    Time frame: Day 0

    VO2max (mL/min/kg) is measured with a Jaeger Oxycon Pro ergospirometer before starting cardiac rehabilitation.

  42. Aerobic capacity: VO2max at Week 8

    Time frame: Week 8

    VO2max (mL/min/kg) is measured with a Jaeger Oxycon Pro ergospirometer after undergoing 8 weeks of cardiac rehabilitation.

  43. Aerobic capacity: Maximal aerobic power (MAP) on Day 0

    Time frame: Day 0

    MAP (watts) is measured with a Jaeger Oxycon Pro ergospirometer before starting cardiac rehabilitation .

  44. Aerobic capacity : Maximal aerobic power (MAP) at Week 8

    Time frame: Week 8

    MAP (watts) is measured with a Jaeger Oxycon Pro ergospirometer after undergoing 8 weeks of cardiac rehabilitation .

  45. Aerobic capacity: ventilation threshold (mL/min/kg) on Day 0

    Time frame: Day 0

    The ventilation threshold VT1 (mL/min/kg) is measured with a Jaeger Oxycon Pro before starting cardiac rehabilitation.

  46. Aerobic capacity: ventilation threshold (mL/min/kg) at Week 8

    Time frame: Week 8

    The ventilation threshold VT1 (mL/min/kg) is measured with a Jaeger Oxycon Pro ergospirometer after undergoing 8 weeks of cardiac rehabilitation.

  47. Aerobic capacity: walking on Day 0

    Time frame: Day 0

    Performance at a 6-minute (m) walk is measured with a Jaeger Oxycon Pro ergospirometer before starting cardiac rehabilitation.

  48. Aerobic capacity: walking at Week 8

    Time frame: Week 8

    Performance at a 6-minute (m) walk is measured with a Jaeger Oxycon Pro ergospirometer after undergoing 8 weeks of cardiac rehabilitation.

  49. Weight on Day 0

    Time frame: Day 0

    The patient's weight will be measured in kilograms before beginning cardiac rehabilitation.

  50. Weight at Week 8

    Time frame: Week 8

    The patient's weight will be measured in kilograms after undergoing 8 weeks of cardiac rehabilitation.

  51. Height on Day 0

    Time frame: Day 0

    The patient's height will be measured in centimeters before beginning cardiac rehabilitation.

  52. Height at Week 8

    Time frame: Week 8

    The patient's height will be measured in centimeters after undergoing 8 weeks of cardiac rehabilitation.

  53. Waist measurement on Day 0

    Time frame: Day 0

    The patient's waist measurement will be noted in centimeters before beginning cardiac rehabilitation.

  54. Waist measurement at Week 8

    Time frame: Week 8

    The patient's waist measurement will be noted in centimeters after undergoing 8 weeks of cardiac rehabilitation.

  55. Body Mass Index on Day 0

    Time frame: Day 0

    The patient's Body Mass Index will be calculated in kg/m2 before beginning cardiac rehabilitation.

  56. Body Mass Index at Week 8

    Time frame: Week 8

    The patient's Body Mass Index will be calculated in in kg/m2 after undergoing 8 weeks of cardiac rehabilitation.

  57. Medicinal treatment on Day 0

    Time frame: Day 0

    Any medicinal treatment that the patient may be following will be noted before beginning cardiac rehabilitation.

  58. Medicinal treatment at Week 8

    Time frame: Week 8

    Any medicinal treatment that the patient may be following will be noted after undergoing 8 weeks of cardiac rehabilitation.

  59. Hemoglobin in g/dL on Day 0

    Time frame: Day 0

    A blood sample will be taken before beginning cardiac rehabilitation and Hemoglobin will be measured in g/dL.

  60. Hemoglobin in g/dL at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Hemoglobin will be measured in g/dL.

  61. Percentage volume of Hematocrit on Day 0

    Time frame: Day 0

    A blood sample will be taken before beginning cardiac rehabilitation and Hematocrit will be measured as a percentage.

  62. Percentage volume of Hematocrit at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Hematocrit will be measured as a percentage.

  63. Mean Corpuscular Volume in femtoliters on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and Mean Corpuscular Volume will be measured in fL.

  64. Mean Corpuscular Volume in femtoliters at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Mean Corpuscular Volume will be measured in fL.

  65. Platelets in G/L on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and platelets will be measured in G/L.

  66. Platelets in G/L at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and platelets will be measured in G/L.

  67. Leukocytes in G/L on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and leukocytes will be measured in G/L.

  68. Leukocytes in G/L at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and leukocytes will be measured in G/L.

  69. C-reactive Protein on Day 0

    Time frame: Day 0

    A blood sample will be taken before beginning cardiac rehabilitation and C-reactive Protein will be measured in mg/L.

  70. C-reactive Protein at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and C-reactive Protein will be measured in mg/L.

  71. Potassium in millimoles per liter on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and potassium will be measured in mmol/l.

  72. Potassium in millimoles per liter at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and potassium will be measured in mmol/l.

  73. Sodium in millimoles per liter on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and sodium will be measured in mmol/l.

  74. Sodium in millimoles per liter at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and sodium will be measured in mmol/l.

  75. Urea on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and urea will be measured in milligrams per deciliter.

  76. Urea at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and urea will be measured in milligrams per deciliter.

  77. Creatinine on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and creatinine will be measured in milligrams per deciliter.

  78. Creatinine at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and creatinine will be measured in milligrams per deciliter.

  79. Fasting glucose on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and fasting glucose will be measured in milligrams per deciliter.

  80. Fasting glucose at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and creatinine will be measured in milligrams per deciliter.

  81. HbA1c on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and HbA1c will be measured as a percentage.

  82. HbA1c at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and HbA1c will be measured as a percentage.

  83. Aspartate Aminotransferase on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and Aspartate Aminotransferase will be measured in units per liter.

  84. Aspartate Aminotransferase at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Aspartate Aminotransferase will be measured in units per liter.

  85. Alanine Aminotransferase on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and Alanine Aminotransferase will be measured in units per liter.

  86. Alanine Aminotransferase at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Alanine Aminotransferase will be measured in units per liter.

  87. Alkaline phosphatase on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and Alkaline phosphatase will be measured in units per liter.

  88. Alkaline phosphatase at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Alkaline phosphatase will be measured in units per liter.

    , bilirubin,Gamma-glutamyltransferase, total cholesterol, Low Density Lipoprotein-cholesterol, High Density Lipoprotein-cholesterol, triglycerides, NT-proB-type Natriuretic Peptides, micro-RNA (miRNA-22, miRNA208-a and miRNA 423-5p).

  89. Creatine phosphokinase on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation Creatine phosphokinase will be measured in units per liter.

  90. Creatine phosphokinase at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Creatine phosphokinase will be measured in units per liter.

  91. Bilirubin on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and bilirubin will be measured in milligrams per deciliter.

  92. Bilirubin at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and bilirubin will be measured in milligrams per deciliter.

  93. Gamma-glutamyltransferase on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and gamma-glutamyltransferase will be measured in units per liter.

  94. Gamma-glutamyltransferase at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Gamma-glutamyltransferase will be measured in units per liter.

  95. Total cholesterol on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and total cholesterol will be measured in milligrams per deciliter.

  96. Total cholesterol at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and bilirubin will be measured in milligrams per deciliter.

  97. Low Density Lipoprotein-cholesterol on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and low density lipoprotein-cholesterol will be measured in milligrams per deciliter.

  98. Low Density Lipoprotein-cholesterol at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and low density lipoprotein-cholesterol will be measured in milligrams per deciliter.

  99. High Density Lipoprotein-cholesterol on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and high density lipoprotein-cholesterol will be measured in milligrams per deciliter.

  100. High Density Lipoprotein-cholesterol at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and high density lipoprotein-cholesterol will be measured in milligrams per deciliter.

  101. Triglycerides on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and triglycerides will be measured in milligrams per deciliter.

  102. Triglycerides at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and triglycerides will be measured in milligrams per deciliter.

  103. NT-proB-type Natriuretic Peptides on Day 0

    Time frame: Day 0

    A blood sample will be taken before starting cardiac rehabilitation and NT-proB-type natriuretic peptides will be measured in picograms per milliliter.

  104. NT-proB-type Natriuretic Peptides at Week 8

    Time frame: Week 8

    A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and NT-proB-type natriuretic peptides will be measured in picograms per milliliter.

  105. Micro-RNA dosage (miRNA22, miRNA122, miRNA150, miRNA208 a/b and miRNA 423-5p) on Day 0

    Time frame: Day 0

    Micro-RNAs (including, notably, miRNA22, miRNA122, miRNA150, miRNA208 a/b and miRNA 423-5p) dosed via reverse-transcriptase quantitative polymerase chain reaction (PCR). PCR consists of an organic extraction stage followed by immobilization of RNA on an apparatus to purify it before elution. PCR provides numerous copies of a chosen DNA sequence. Real time quantitative PCR provides the quantity of DNA at each amplification cycle thanks to SYBR® Green, an intercalating fluorescent DNA agent, which emits a quantity of fluorescence for each amplicon produced. Fluorescence is thus directly proportional to the quantity of DNA in the sample. RNA extractions will be made from 200 μL of plasma collected before the patient starts cardiac rehabilitation and analyzed by researchers at Aix-Marseille University - INSERM, UMR 1260 C2VN Center for Cardiovascular and Nutrition research. Frozen samples will be shipped from Nîmes and Avignon to Marseille by Cryoglobe package.

  106. Micro-RNA dosage (miRNA22, miRNA122, miRNA150, miRNA208 a/b and miRNA 423-5p) at Week 8

    Time frame: Week 8

    Micro-RNAs (including, notably, miRNA22, miRNA122, miRNA150, miRNA208 a/b and miRNA 423-5p) dosed via reverse-transcriptase quantitative polymerase chain reaction (PCR). PCR consists of an organic extraction stage followed by immobilization of RNA on an apparatus to purify it before elution. PCR provides numerous copies of a chosen DNA sequence. Real time quantitative PCR provides the quantity of DNA at each amplification cycle thanks to SYBR® Green, an intercalating fluorescent DNA agent, which emits a quantity of fluorescence for each amplicon produced. Fluorescence is thus directly proportional to the quantity of DNA in the sample. RNA extractions will be made from 200 μL of plasma collected after the patient has had 8 weeks of cardiac rehabilitation and analyzed by researchers at Aix-Marseille University - INSERM, UMR 1260 C2VN Center for Cardiovascular and Nutrition research. Frozen samples will be shipped from Nîmes and Avignon to Marseille by Cryoglobe package.

  107. Quality of life according to the WHOQOL-BREF Questionnaire on Day 0

    Time frame: Day 0

    Before starting cardiac rehabilitation, the patient's quality of life is measured with the WHOQOL-BREF, a short version of the WHOQOL-100 quality of life assessment developed by the WHOQOL group with fifteen international field centres, simultaneously (Orley & Kuyken, 1994; Szabo, 1996; WHOQOL Group 1994a, 1994b, 1995). The WHOQOL-BREF questionnaire contains two items from the Overall QOL and General Health and 24 items of satisfaction divided into four domains: Physical health with 7 items (DOM1), psychological health with 6 items (DOM2), social relationships with 3 items (DOM3) and environmental health with 8 items (DOM4). Each item is rated on a 5-point Likert scale.The four domain scores denote an individual's perception of quality of life in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score.

  108. Quality of life according to the WHOQOL-BREF Questionnaire at Week 8

    Time frame: Week 8

    After undergoing cardiac rehabilitation for 8 weeks, the patient's quality of life is measured with the WHOQOL-BREF, a short version of the WHOQOL-100 quality of life assessment developed by the WHOQOL group with fifteen international field centres, simultaneously (Orley & Kuyken, 1994; Szabo, 1996; WHOQOL Group 1994a, 1994b, 1995). The WHOQOL-BREF questionnaire contains two items from the Overall QOL and General Health and 24 items of satisfaction divided into four domains: Physical health with 7 items (DOM1), psychological health with 6 items (DOM2), social relationships with 3 items (DOM3) and environmental health with 8 items (DOM4). Each item is rated on a 5-point Likert scale.The four domain scores denote an individual's perception of quality of life in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score.

  109. Quality of life according to the MacNew Questionnaire at Day 0

    Time frame: Day 0

    Before starting cardiac rehabilitation, the patient's quality of life is measured with the MacNew Questionnaire, which is a self-administered modified version of the original QLMI instrument. The MacNew is designed to assess the patient's feelings about how Myocardial Infarction affects daily functioning and contains 27 items with a global Health-Related Quality of Life (HRQoL) score and subscales regarding physical limitation, emotional, and social function. There are 5 items that inquire about symptoms: angina/chest pain, shortness of breath, fatigue, dizziness, and aching legs.The items and scales are scored from 1 (low HRQoL) to 7 (high HRQoL), and the minimal important difference on each MacNew scale is 0.50 points. The time frame for the MacNew is the previous two weeks.

  110. Quality of life according to the MacNew Questionnaire at Week 8

    Time frame: Week 8

    After undergoing cardiac rehabilitation for 8 weeks, the patient's quality of life is measured with the MacNew Questionnaire, which is a self-administered modified version of the original QLMI instrument.The MacNew is designed to assess the patient's feelings about how Myocardial Infarction affects daily functioning and contains 27 items with a global Health-Related Quality of Life (HRQoL) score and subscales regarding physical limitation, emotional, and social function. There are 5 items that inquire about symptoms: angina/chest pain, shortness of breath, fatigue, dizziness, and aching legs. The items and scales are scored from 1 (low HRQoL) to 7 (high HRQoL), and the minimal important difference on each MacNew scale is 0.50 points. The time frame for the MacNew is the previous two weeks.

  111. Observance of the rehabilitation program

    Time frame: Day 0 to Week 8

    An attendance sheet must be filled in by all patients, each time they attend their rehabilitation session whether they are assigned to the the control group (CONT) with three 40-minute sessions per week or the experimental group doing intermittent training (IT) with three 45-minute sessions per week.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Comparison of Two Exercise Training Modalities on Left Myocardial Regional Function After MI (Myocardial Infarction) Evaluated by 2D Strain Ultrasound - a Randomized Controlled Bicentric Study

Acronym: STRAICT

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2019
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Published trials that share one or more normalized conditions with this study.