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IRCT20201022049111N1 IRCT 2020-11-29 Khoram-Abad University of Medical Sciences Effect of High-Intensity Interval Training on Cardiac Rehabilitation among Myocardial Infarction Patients Comparison of the Effectiveness of Cardiac Rehabilitation based on High- volume (HV-HIIT) and low-volume (LV-HIIT) High-Intensity Interval Training on Serum levels of some miRNAs, myocardial contractile biomarkers , Inflammatory and Functional Markers in Myocardial Infarction Patients 2020-11-19 anticipated 128 Complete https://irct.ir/trial/51974 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method of randomization will be the permuted block randomization (42patients per block) with stratification based on age and sex.A random allocation sequence list will be generated using a web-based app, that is, Random.org.An independent research assistant who did not participate in any other parts of the research will be generated and maintained the random allocation sequence list. This independent research assistant will assign group labels to the participants according to the sequence of their entry, referring to the random allocation sequence list to ensure that the other members of the research team did not foresee the group allocation. Allocation concealment will be performed by sequentially numbered sealed opaque envelopes. independent research assistant generated the random allocation sequence and distributed these in serially numbered sealed opaque envelopes. Envelopes will be opened in a sequential manner (serial number in participant list and serial number mentioned on top of envelope will be the same in all cases) in the presence of the participant and a witness (usually family member of the participant), and intervention allocation will be implemented accordingly, Blinding description: The study will be double-blind. Medical staff will be blinded by the random assignment of participants in study groups. The assignment will be performed by a sports physiologist who is not involved in the testing process. Both participants and researchers or outcome assessors are unaware of the assignment of study groups. N/A Myocardial infarction. Intervention 1: Intervention group 1 (HV-HIIT group): A training session on the treadmill at 4 × 4-minute intervals at 90% of HRr with 3 minutes of active recovery at 65% of HRr between intervals and a training session on the bike with 16× 30 seconds intervals with 60 seconds of active recovery at 65% of HRr between intervals , with total exercise of 40 minutes/session. Intervention 2: Intervention group2 (LV-HIIT group): A training session on the treadmill with two 4-minute intervals at an interval intensity of ∼85% HRr with 3 minutes of active recovery at 65% of HRr between intervals and a training session on the bike with 8× 30 seconds intervals with 60 seconds of active recovery at 70% of HRr between intervals, with total exercise of 20 minutes/session. Intervention 3: Control group: The control group will receive regular physical exercise recommendations to keep ethical procedures regarding health. In this sense, participants will be advised to participate, without supervision, in at least 30 min of moderate-intensity dynamic aerobic exercise (walking, jogging, cycling, or swimming) 5–7 days per week. Yes - There is a plan to make this available What will be shared: Some of the data on the main outcome can be shared after people are not identified. When: Starting available 6 months after the publication of results To whom: Only for researchers working in academic and scientific institutions will be available. Conditions: Only for meta-analysis research Where to obtain: Dr. Mostafa Cheraghi.,Cardiovascular Research Center.,Lorestan University of Medical Sciences. How to obtain: Written and co-ordination of the organs of the Cardiovascular Research Center, Lorestan University of Medical Sciences Comments:
public Mustafa Cheraghi
Lorestan University of Medical Sciences, Shahid Anooshirvan Rezaei square, Moallem street
Khorramabad Iran (Islamic Republic of) 6813833946 +98 66 4230 8790 Dcheraghi406@gmail.com Khoram-Abad University of Medical Sciences scientific Mustafa Cheraghi
Lorestan University of Medical Sciences, Shahid Anooshirvan Rezaei square, Moallem street
Khorramabad Iran (Islamic Republic of) 6813833946 +98 66 4230 8790 Dcheraghi406@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) MI type 1 and having an ejection fraction of 40% At least six to two years have passed since the diagnosis and angioplasty Be in a stable condition without drug changes In class II, I have cardiac function. Maximum metabolic equivalent to or more than 5 MET 45 years 60 years Both Metabolic diseases such as diabetes and obesity Variable blood pressure Congestive heart failure Dangerous arrhythmias Liver and kidney failure Chronic obstructive pulmonary disease Neuromuscular disorders I25 Chronic ischemic heart disease Rehabilitation Rehabilitation Rehabilitation Intervention group 1 (HV-HIIT group): A training session on the treadmill at 4 × 4-minute intervals at 90% of HRr with 3 minutes of active recovery at 65% of HRr between intervals and a training session on the bike with 16× 30 seconds intervals with 60 seconds of active recovery at 65% of HRr between intervals , with total exercise of 40 minutes/session. Intervention group2 (LV-HIIT group): A training session on the treadmill with two 4-minute intervals at an interval intensity of ∼85% HRr with 3 minutes of active recovery at 65% of HRr between intervals and a training session on the bike with 8× 30 seconds intervals with 60 seconds of active recovery at 70% of HRr between intervals, with total exercise of 20 minutes/session Control group: The control group will receive regular physical exercise recommendations to keep ethical procedures regarding health. In this sense, participants will be advised to participate, without supervision, in at least 30 min of moderate-intensity dynamic aerobic exercise (walking, jogging, cycling, or swimming) 5–7 days per week. Expression of miR-1. Timepoint: Before and after the intervention. Method of measurement: Real time – PCR. C-Reactive Protein (CRP). Timepoint: Before and after the intervention. Method of measurement: by using the immunometric assay technique method and ELISA Kit. Uric acid. Timepoint: Before and after the intervention. Method of measurement: by using the immunometric assay technique method and ELISA Kit. Expression of miR-208. Timepoint: Before and after the intervention. Method of measurement: Real time – PCR. Expression of miR-133. Timepoint: Before and after the intervention. Method of measurement: Real time – PCR. Expression of mRNACapas3. Timepoint: Before and after the intervention. Method of measurement: Real time – PCR. CK-mb. Timepoint: Before and after the intervention. Method of measurement: by using the immunometric assay technique method and ELISA Kit. Troponin. Timepoint: Before and after the intervention. Method of measurement: by using the immunometric assay technique method and ELISA Kit. Quality of Life. Timepoint: Before and after the intervention. Method of measurement: Quality of Life Questionnaire. Ejection fraction. Timepoint: Before and after the intervention. Method of measurement: Echocardiography and Simpson. Systolic blood pressure. Timepoint: Before and after the intervention. Method of measurement: Digital blood pressure device. Maximal Oxygen Consumption (peak VO2). Timepoint: Before and after the intervention. Method of measurement: Exercise stress test. End-systolic volume. Timepoint: Before and after the intervention. Method of measurement: M-mode echocardiography. Diastolic blood pressure. Timepoint: Before and after the intervention. Method of measurement: Digital blood pressure device. End-Diastolic volume. Timepoint: Before and after the intervention. Method of measurement: M-mode echocardiography. Khoram-Abad University of Medical Sciences Approved 2019-11-08 Ethics Committee of Clinical Investigation of Lorestan University of Medical Sciences Lorestan University of Medical Sciences, Shahid Anooshirvan Rezaei square, Moallem street Khorramabad Lorestan Iran (Islamic Republic of) Approved 2020-10-06 Ethics Committee of Clinical Investigation of Lorestan University of Medical Sciences Lorestan University of Medical Sciences, Shahid Anooshirvan Rezaei square, Moallem street Khorramabad Lorestan Iran (Islamic Republic of)