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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Longitudinal systolic strain at Week 8.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The evaluator will not know which group of patients the results are from.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Patients following the CONT program
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
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.
干预措施: Intermittent retraining program. (Other)
结局指标
主要结局
Longitudinal systolic strain at Week 8.
时间窗: 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.
Longitudinal systolic strain on Day 0.
时间窗: 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.
次要结局
- Circumferential strain at Week 8(Week 8)
- Diastolic radial strain at Week 8(Week 8)
- Diastolic radial strain on Day 0(Day 0)
- Apical rotation on Day 0(Day 0)
- Longitudinal diastolic strain on Day 0(D0)
- Longitudinal diastolic strain at Week 8(Week 8)
- Waist measurement on Day 0(Day 0)
- Systolic circumferential strain at Week 8(Week 8)
- Diastolic circumferential strain at Week 8(Week 8)
- Circumferential strain on Day 0(Day 0)
- Systolic radial strain on Day 0(Day 0)
- Systolic radial strain at Week 8(Week 8)
- Diastolic circumferential strain on Day 0(Day 0)
- Apical rotation at Week 8(Week 8)
- Basal rotation at Week 8(Week 8)
- Ventricular torsion on Day 0(Day 0)
- Cardiac morphology : Systolic ejection volume at Week 8(Week 8)
- Systolic circumferential strain on Day 0(D0)
- Intraventricular asynchrony at Week 8(Week 8)
- Cardiac morphology : Left ventricle mass on Day 0(Day 0)
- Cardiac morphology : S' wave on Day 0(Day 0)
- Cardiac morphology : E/A ratio at Week 8(Week 8)
- Aerobic capacity: ventilation threshold (mL/min/kg) on Day 0(Day 0)
- Leukocytes in G/L on Day 0(Day 0)
- Basal rotation on Day 0(Day 0)
- Intraventricular asynchrony on Day 0(Day 0)
- Cardiac morphology : Telesystolic volume at Week 8(Week 8)
- Cardiac morphology : Telediastolic volume on Day 0(Day 0)
- Cardiac morphology : Left ventricle mass at Week 8(Week 8)
- Cardiac morphology : S' wave at Week 8(Week 8)
- Cardiac morphology : E' wave at Week 8(Week 8)
- Cardiac morphology : A' wave at Week 8(Week 8)
- Cardiac morphology : E/E' ratio at Week 8(Week 8)
- Cardiac morphology : Telediastolic volume at Week 8(Week 8)
- Cardiac morphology : FEVG at Day 0(Day 0)
- Cardiac morphology : E/E' ratio on Day 0(Day 0)
- Aerobic capacity: VO2max at Week 8(Week 8)
- Height on Day 0(Day 0)
- Medicinal treatment at Week 8(Week 8)
- Percentage volume of Hematocrit on Day 0(Day 0)
- Platelets in G/L on Day 0(Day 0)
- C-reactive Protein on Day 0(Day 0)
- Ventricular torsion at Week 8(Week 8)
- Cardiac morphology : Telesystolic volume on Day 0(D0)
- Cardiac morphology : FEVG at Week 8(Week 8)
- Cardiac morphology : E/A ratio on Day 0(Day 0)
- Cardiac morphology : Systolic ejection volume on Day 0(Day 0)
- Aerobic capacity: VO2max on Day 0(Day 0)
- Aerobic capacity : Maximal aerobic power (MAP) at Week 8(Week 8)
- Aerobic capacity: walking on Day 0(Day 0)
- Cardiac morphology : E' wave at Day 0(Day 0)
- Cardiac morphology : A' wave on Day 0(Day 0)
- Aerobic capacity: Maximal aerobic power (MAP) on Day 0(Day 0)
- Aerobic capacity: walking at Week 8(Week 8)
- Weight at Week 8(Week 8)
- Body Mass Index at Week 8(Week 8)
- Hemoglobin in g/dL on Day 0(Day 0)
- Hemoglobin in g/dL at Week 8(Week 8)
- Aerobic capacity: ventilation threshold (mL/min/kg) at Week 8(Week 8)
- Weight on Day 0(Day 0)
- Height at Week 8(Week 8)
- Mean Corpuscular Volume in femtoliters at Week 8(Week 8)
- Platelets in G/L at Week 8(Week 8)
- Leukocytes in G/L at Week 8(Week 8)
- Sodium in millimoles per liter on Day 0(Day 0)
- Urea on Day 0(Day 0)
- Waist measurement at Week 8(Week 8)
- Body Mass Index on Day 0(Day 0)
- Medicinal treatment on Day 0(Day 0)
- Percentage volume of Hematocrit at Week 8(Week 8)
- C-reactive Protein at Week 8(Week 8)
- Potassium in millimoles per liter on Day 0(Day 0)
- Potassium in millimoles per liter at Week 8(Week 8)
- Urea at Week 8(Week 8)
- Creatinine on Day 0(Day 0)
- Creatinine at Week 8(Week 8)
- Alanine Aminotransferase at Week 8(Week 8)
- Alkaline phosphatase on Day 0(Day 0)
- Mean Corpuscular Volume in femtoliters on Day 0(Day 0)
- Sodium in millimoles per liter at Week 8(Week 8)
- Fasting glucose on Day 0(Day 0)
- HbA1c on Day 0(Day 0)
- HbA1c at Week 8(Week 8)
- Creatine phosphokinase at Week 8(Week 8)
- Gamma-glutamyltransferase at Week 8(Week 8)
- Triglycerides at Week 8(Week 8)
- Fasting glucose at Week 8(Week 8)
- Triglycerides on Day 0(Day 0)
- NT-proB-type Natriuretic Peptides at Week 8(Week 8)
- Micro-RNA dosage (miRNA22, miRNA122, miRNA150, miRNA208 a/b and miRNA 423-5p) on Day 0(Day 0)
- Alanine Aminotransferase on Day 0(Day 0)
- Total cholesterol on Day 0(Day 0)
- Quality of life according to the MacNew Questionnaire at Week 8(Week 8)
- Aspartate Aminotransferase on Day 0(Day 0)
- Aspartate Aminotransferase at Week 8(Week 8)
- Creatine phosphokinase on Day 0(Day 0)
- Bilirubin at Week 8(Week 8)
- Low Density Lipoprotein-cholesterol on Day 0(Day 0)
- NT-proB-type Natriuretic Peptides on Day 0(Day 0)
- Quality of life according to the WHOQOL-BREF Questionnaire at Week 8(Week 8)
- Quality of life according to the MacNew Questionnaire at Day 0(Day 0)
- Observance of the rehabilitation program(Day 0 to Week 8)
- Alkaline phosphatase at Week 8(Week 8)
- Bilirubin on Day 0(Day 0)
- Gamma-glutamyltransferase on Day 0(Day 0)
- Total cholesterol at Week 8(Week 8)
- Low Density Lipoprotein-cholesterol at Week 8(Week 8)
- High Density Lipoprotein-cholesterol on Day 0(Day 0)
- High Density Lipoprotein-cholesterol at Week 8(Week 8)
- Quality of life according to the WHOQOL-BREF Questionnaire on Day 0(Day 0)
- Micro-RNA dosage (miRNA22, miRNA122, miRNA150, miRNA208 a/b and miRNA 423-5p) at Week 8(Week 8)