The Effect of HIIT, MICT in Patients With Myocardial Infarction

Study Overview
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Brief Summary
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This study will investigate the effect of a 12-weeks cardiac rehabilitation training (HIIT, MICT) program on VO2peak and cardiac fibrosis in patients, and evaluate the effects of HIIT on endothelial function, microvascular obstruction, body fat, inflammation, arrhythmia and psychology .

Detailed Description
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Eligible and consenting patients are randomized (block randomization) in a 1:1:1 ratio. According to the number of 180 samples calculated by the sample size, the random number table containing 1-180 ( including shedding cases ) was obtained by the computer. Case number will be assigned to participants in each group according to the order of grouping, and each case number corresponded to Group1(HIIT), 2(MICT) or 3(Control) according to the random number. The HIIT sessions include brief, intermittent bouts of high-intensity exercise interspersed with periods of low-intensity exercise (active recovery). HIIT include 20 intervals of high-intensity (30-60s at rating of perceived exertion (RPE; Borg scale of 6-20) of 15 to 17) and low-intensity (1min at RPE <10 or totally rest). The whole exercise cycle takes around 40-50 minutes (Figure 2). In MICT Group, patients perform 40-50 minutes at a RPE of 12 to 14(a total of 4 groups, each group 5-8 min, interspersed with 2-minute rest)(Figure 3). HIIT and MICT are performed only during supervised sessions with non-consecutive 3 days/week. And all patients are supervised by professional CR team. After assessing by therapists and doctors, participants also can perform three days of home-based exercises guided by wearing a sports bracelet. The CR program includes 36 sessions supervised exercises, pharmacological counseling, patient education, catering management, smoking cessation counseling, stress management, and psychological counseling. A standard 36 sessions of CR usually lasts 12 weeks (three sessions per week).

Official Title
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Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity on Peak Oxygen Uptake and Myocardial Fibrosis in Patients With Myocardial Infarction: Protocol for a Randomized Controlled Trial

Conditions
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Myocardial Infarction, Cardiopulmonary Disease, Training Group, Sensitivity

Intervention / Treatment
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* Behavioral: High Intensity Interval Training(HIIT）
* Behavioral: Moderate Intensity Continuous Training(MICT）


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 -75 years Acute myocardial infarction (AMI) patients between 6 weeks and 3 months and had been underwent revascularization, and New York Heart Association functional classification (NYHA) Class I-III; (AMI confirmed by the World Health Organization definition (presence of symptoms of ischemia and changes in electrocardiogram) or the Third Universal Definition of Myocardial Infarction (elevation of a cardiac biomarker along with presence of either symptoms of myocardial infarction or changes in electrocardiogram)) Willing and able to attend the complete cardiac rehabilitation(CR)program on their own，assigned the Informed consent form. Complete the cardiopulmonary exercise testing (CPET) at enrollment or has the CPET report within 1 month. Exclusion Criteria: High-intensity exercise frequently Currently participating in any other clinical trials Have any other diseases which limit their life to less than a year (e.g. severe valvular disease, recurrent ventricular arrhythmias, NYHA Class IV heart failure, severe aortic incompetence, severe atrial fibrillation, cancers, and end-stage renal or liver disease) Dementia ; disability or sports contraindication Severe acute liver failure Severe acute renal failure Unstable vital signs Site investigators consider that the patient will be unable to complete the study and/or attend for follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Interval Training(HIIT)<br>The HIIT sessions include brief, intermittent bouts of high-intensity exercise interspersed with periods of low-intensity exercise (active recovery).HIIT include 20 intervals of high-intensity (30-60s at rating of perceived exertion (RPE; Borg scale of 6-20) of 15 to 17) and low-intensity (1min at RPE <10 or totally rest). The whole exercise cycle takes around 40-50 minutes. | Behavioral: High Intensity Interval Training(HIIT）<br>* Last 12 weeks (3 sessions per week)<br>|
| Experimental: Moderate Intensity Continuous Training(MICT)<br>Patients perform 40-50 minutes at a RPE of 12 to 14(a total of 4 groups, each group 5-8 min, interspersed with 2-minute rest) | Behavioral: Moderate Intensity Continuous Training(MICT）<br>* Moderate Intensity Continuous Training(MICT）<br>|
| No Intervention: Control Group<br>No additional rehabilitation treatment or physical exercise was added in Control Group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of HIIT/MICT on VO2peak | Changes in VO2peak after 3-month cardiac rehabilitation training ( HIIT, MICT), assessed by cardiopulmonary exercise testing. | 3 months | 
| Evaluate the degree of cardiac fibrosis in 3 groups by cardiac magnetic resonance | The effect of HIIT/MICT on myocardial fibrosis in patients with MI, assessed by cardiac magnetic resonance. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of HIIT/MICT on Stromelysin-2 | Blood samples will be taken to detect Stromelysin-2, to evaluate the effect of HIIT/MICT on Stromelysin-2. | 3 months | 
| The effect of HIIT/MICT on endothelial function as assessed by the Endo-PAT2000 | Endothelial function will be assessed using the Endo-PAT2000 (Itamar Medical), which measures the finger pulse volume amplitude (PVA) using volume plethysmography technology to reflect peripheral blood volume changes. | 3 months | 
| The effect of HIIT/MICT on microvascular obstruction as assessed by cardiac magnetic resonance | The effect of HIIT/MICT on microvascular obstruction,assessed by cardiac magnetic resonance. | 3 months | 
| The effect of HIIT/MICT on body fat | The effect of HIIT/MICT on body fat | 3 months | 
| The effect of HIIT/MICT on quality of life as assessed by SF-36 | The effect of HIIT/MICT on quality of life as assessed by SF-36 | 3 months | 
| The effect of HIIT/MICT on the incidence of arrhythmia, assessed by 24h dynamic electrocardiogram | The effect of HIIT/MICT on the incidence of arrhythmia,assessed by 24h dynamic electrocardiogram. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Intensity Intermittent Training, Myocardial Infarction, Moderate Intensity Continuous Training, Cardiac Rehabilitation, Cardiopulmonary exercise testing