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IRCT20211031052926N1 IRCT 2021-11-13 Hamedan University of Medical Sciences The effect of exercise program intervention on diabetes The effect of a submaximal alternative exercise program on heart rate variability profile (HRV), selected resting echocardiographic factors and presentation of multivariate predictive clinical regression model in boys with type 1 diabetes 2021-09-23 anticipated 36 Complete https://irct.ir/trial/59685 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: The study included two groups of type 1 diabetics and one healthy group. Exercise intervention is performed only on one diabetic group. The other diabetic group and the healthy group are controls. N/A Type 1 diabetes. Intervention 1: Intervention group: The intermittent exercise program includes a combination of strength and sub-maximal aerobic exercise for twelve consecutive weeks with an average of 65% heart rate, telemetry, each morning workout on grass and outdoor sports gradually from 30 to 60 minutes below lactate threshold and at a safe level with Supervised by instructors and consultants. The first week includes: 5 minutes of warm-up, 15 minutes of flexibility exercises, 10 minutes of strength exercises (3 to 10 sets of different movements with the individual's own body weight) 10 minutes of aerobic exercise with 50% heart rate reserve 5 minutes of cooling (30 minutes HRR) with an intensity of 50%. Over 12 weeks, 5 minutes of flexibility exercises, 15 minutes of strength exercises (3 to 10 sets of upper and lower body exercises with weights and stretching), 35 minutes of intermittent aerobic exercise with 70 to 75% reserve heart rate (50-55). Minutes with an intensity of 70% HRR). Intervention 2: The diabetic group continued their daily activities, including recreational and sports activities, in addition to regular aerobic and resistance activities in sports venues. Intervention 3: This healthy group continued their daily activities, including recreational and sports activities, in addition to regular aerobic and resistance activities in sports venues. Yes - There is a plan to make this available What will be shared: Blood data, exercise test and echo and Holter When: 11401 onwards To whom: Research results are published for everyone's use Conditions: To help patients, their families, doctors and sports coaches Where to obtain: Research results are published for everyone's use How to obtain: Research results are published for everyone's use Comments:
public Hossein Saki
Hamedan. Shahid Ahmadi Roshan Boulevard. Bu Ali Sina University. Faculty of Physical Education and Sports Sciences
Hamedan Iran (Islamic Republic of) 6793137936 +98 81 3349 3468 hossein.saki1990@yahoo.com Hamedan University of Medical Sciences scientific Hossein Saki
Hamedan. Shahid Ahmadi Roshan Boulevard. Bu Ali Sina University. Faculty of Physical Education and Sports Sciences
Hamedan Iran (Islamic Republic of) 6793137936 +98 81 3349 3468 hossein.saki1990@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Type 1 diabetic boys in the age range of 12 to 18 years Having Hba1c more than 6% History of at least 2 years of diabetes 12 years 18 years Male Symptoms of diabetic neuropathy, cerebrovascular or ocular diseases, and respiratory failure Taking certain medications other than insulin Taking drugs that affect resting heart rate High blood pressure Have regular exercise during the week E10 Type 1 diabetes mellitus Prevention Early detection Early detection Intervention group: The intermittent exercise program includes a combination of strength and sub-maximal aerobic exercise for twelve consecutive weeks with an average of 65% heart rate, telemetry, each morning workout on grass and outdoor sports gradually from 30 to 60 minutes below lactate threshold and at a safe level with Supervised by instructors and consultants. The first week includes: 5 minutes of warm-up, 15 minutes of flexibility exercises, 10 minutes of strength exercises (3 to 10 sets of different movements with the individual's own body weight) 10 minutes of aerobic exercise with 50% heart rate reserve 5 minutes of cooling (30 minutes HRR) with an intensity of 50%. Over 12 weeks, 5 minutes of flexibility exercises, 15 minutes of strength exercises (3 to 10 sets of upper and lower body exercises with weights and stretching), 35 minutes of intermittent aerobic exercise with 70 to 75% reserve heart rate (50-55). Minutes with an intensity of 70% HRR). The diabetic group continued their daily activities, including recreational and sports activities, in addition to regular aerobic and resistance activities in sports venues. This healthy group continued their daily activities, including recreational and sports activities, in addition to regular aerobic and resistance activities in sports venues. Epinephrine hormone (ٍEP). Timepoint: Baseline and final (12th week). Method of measurement: Blood samples test. Norepinephrine hormone (NEP). Timepoint: Baseline and final (12th week). Method of measurement: Blood samples test. Glycated hemoglobin (HbA1c). Timepoint: Baseline and final (12th week). Method of measurement: Blood samples test. Fasting blood sugar (FBS). Timepoint: Baseline and final (12th week). Method of measurement: Blood samples test. High-density lipoprotein (HDL) cholesterol. Timepoint: Baseline and final (12th week). Method of measurement: Blood samples test. Low-density lipoprotein (LDL) cholesterol. Timepoint: Baseline and final (12th week). Method of measurement: Blood samples test. Triglyceride (TG). Timepoint: Baseline and final (12th week). Method of measurement: Blood samples test. Total Cholesterol (TC). Timepoint: Baseline and final (12th week). Method of measurement: Blood samples test. Dimensions of aorta (AO). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (M-mode). Dimensions of left atrium (LA). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (M-mode). Right ventricle lateral wall (RV). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (M-mode). Left ventricular internal dimension during diastole (LVIDd). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (M-mode). Left ventricular internal dimension during systole (LVIDs). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (M-mode). Inter ventricular septum (IVS). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (M-mode). Posterior ventricular wall thickness (PW). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (M-mode). Fractional shortening (FS). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (M-mode). Ventricular ejection fraction (EF). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (M-mode). Tricuspid velocity in the initial flow of diastole (E tricuspid). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (pulsed wave). Tricuspid velocity during active atrial contraction (A tricuspid). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (pulsed wave). Deceleration time, from maximum point E to baseline (DT tricuspid). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (pulsed wave). Mitral velocity in the initial flow of diastole (E mitral). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (pulsed wave). Mitral velocity during active atrial contraction (A mitral). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (pulsed wave). Deceleration time, from maximum point E to baseline (DT mitral). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (pulsed wave). Wave S right ventricle (’RV-S). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (tissue Doppler). Wave A right ventricle (RV-A’). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (tissue Doppler). Wave E right ventricle (RV-E’). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (tissue Doppler). Right ventricle isovolumic contruction time (RV-ICT). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (tissue Doppler). Right ventricle isovolumic relaxation time (RV-IRT). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (tissue Doppler). Right ventricle myocardial performance index (RV-MPI). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (tissue Doppler). The ratio of the maximum systolic velocity to the initial right ventricular diastolic flow velocity (RV-E/E’). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (tissue Doppler). The ratio of the maximum systolic velocity to the initial left ventricular diastolic flow velocity (LV-E/E’). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (tissue Doppler). Left ventricle myocardial performance index (LV-MPI). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (tissue Doppler). Left ventricle isovolumic relaxation time (LV-IRT). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (tissue Doppler). Left ventricle isovolumic contruction time (LV-ICT). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (tissue Doppler). Wave E left ventricle (LV-E’). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (tissue Doppler). Wave A left ventricle (LV-A’). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (tissue Doppler). Wave S left ventricle (LV-S’). Timepoint: Baseline and final (12th week). Method of measurement: Echocardiography (tissue Doppler). The functional capacity of the heart. Timepoint: Baseline and final (12th week). Method of measurement: Exercise test. Hamedan University of Medical Sciences Approved 2021-10-20 Ethics Committee of Hamedan University of Medical Sciences Hamedan. Shahid Ahmadi Boulevard clear. Bu Ali Sina University. Faculty of Physical Education and Sport Sciences Hamedan Hamadan Iran (Islamic Republic of)