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IRCT20221026056299N1 IRCT 2023-07-12 Esfahan University of Medical Sciences Comparisonthe effectiveness of a 6 months home-based aerobic High-intensity interval training and resistance exercises on glycemic of adolescents with type 1 diabetes mellitus Comparison the effectiveness of a 6 months home-based aerobic High-intensity interval training (HIIT) and resistance exercises on glycemic and metabolic control of adolescents with type 1 diabetes mellitus and identification of disease related microRNAs 2023-01-21 anticipated 90 Complete https://irct.ir/trial/66589 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization,table of random number In this study, first the subjects (90 people) are selected and a two-digit code is assigned to each of them, and the researcher randomly starts from a point of the table in the direction of the row or column to select the sample people from the table considering the last two digits of the numbers in the table as follows;the first 30 as the control group, the second 30 as the intervention group 1, and the third 30 as the intervention group 2, Blinding description: The adolescents with Type 1 diabetes and the investigator who collect the data and assess the outcomes will be blinded. 3 Type1 diabetes mellitus. Intervention 1: Control group: High-intensity interval training(High intensity interval training (HIIT) is a mode of aerobic exercise training that consists of an activity phase and a rest phase. The activity phase includes some exercises that are performed with high intensity and speed, but the period of rest time is short, such as pedaling on a bicycle or any other exercise activity, and then a rest period is considered). The exercises of each session last for 60-90 minutes, for a period of 12 weeks and 3 sessions per week with direct or indirect supervision of researchers or exercise training specialists. Intervention 2: Intervention group: Resistance exercises(The method of selected resistance exercises will include exercises using body weight or other simple equipment such as exercises with elastic bands). The exercises of each session last for 60-90 minutes, for a period of 12 weeks and 3 sessions per week with direct or indirect supervision of researchers or exercise training specialists. Yes - There is a plan to make this available What will be shared: Non-identifiable data of the participants and information about the investigated outcomes When: starting 6 months after publication To whom: Researchers from academic institutions working in the field of type 1 diabetes mellitus or physical activity Conditions: deidentifiable data Using data to design similar researches Using by health system officials and workers to implement effective interventions at community level and for larger population Where to obtain: The applicant can get their requested documents by contacting with the Principle Investigator Silva Hovsepian s.hovsepian@res.mui.ac.ir How to obtain: After receiving the email with the request to receive the documents, the PI will consult with the project colleagues and if possible, the data will be emailed within 2 weeks. Comments:
public Silva Hovsepian
Hezar Jerib
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5257 s.hovsepian@res.mui.ac.ir Esfahan University of Medical Sciences scientific Silva Hovsepian
Hezar jerib
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5257 s.hovsepian@res.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Adolescents with Type 1 diabetes 14-18 years old 14 years 18 years Both Having movement restriction or movement disorder Having limb or body injuries Chronic cardiac or respiratory diseases, blood pressure Any chronic disease that causes the child's inability to perform physical activity Family history of sudden death, uncontrolled hypertension, type II diabetes and cardiovascular disease E10 Type 1 diabetes mellitus Lifestyle Lifestyle Control group: High-intensity interval training(High intensity interval training (HIIT) is a mode of aerobic exercise training that consists of an activity phase and a rest phase. The activity phase includes some exercises that are performed with high intensity and speed, but the period of rest time is short, such as pedaling on a bicycle or any other exercise activity, and then a rest period is considered). The exercises of each session last for 60-90 minutes, for a period of 12 weeks and 3 sessions per week with direct or indirect supervision of researchers or exercise training specialists. Intervention group: Resistance exercises(The method of selected resistance exercises will include exercises using body weight or other simple equipment such as exercises with elastic bands). The exercises of each session last for 60-90 minutes, for a period of 12 weeks and 3 sessions per week with direct or indirect supervision of researchers or exercise training specialists. Glycemic control. Timepoint: Measurement of Hemoglobin A1c at baseline and 6 months after exercises. Method of measurement: blood test. Metabolic control (lipid profile,fasting blood sugar). Timepoint: At baseline and 6 month after intervention. Method of measurement: Blood test. Esfahan University of Medical Sciences Approved 2022-07-22 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib Isfahan Isfehan Iran (Islamic Republic of)