]>
IRCT20220121053779N1 IRCT 2022-03-05 University of Sistan and Baluchestan Evaluation of the effect of combination training and ISO supplementation in dialysis patients Interactive effect of ISO protein consumption and eight weeks of combined training during dialysis on serum levels of hepcidin , interleukin-6, iron , ferritin and renal function indices, body fat percentage, lipid profile, glycemic index and MIS and DMS scale in hemodialysis patients 2022-03-15 anticipated 35 Complete https://irct.ir/trial/61523 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple random - After selecting the patients who met the age and inclusion criteria, the three groups will be selected by lot in a homogeneous manner. For each group, an equal number of men and women were selected by lot, then based on the age of the people Ages 25-35 years old were written on paper and were selected by lot for each group, then in the age range 35-55 years old, they were homogenized in the same way. N/A Chronic kidney disease. Intervention 1: Intervention group: In the supplement-activity group, the subjects were trained for 8 weeks at the end of each dialysis session (3 sessions per week). Or 24 grams in 150 cc of water will be consumed after each dialysis session. Intervention 2: Intervention group: In the experimental group, the program will perform combined exercises during dialysis, three sessions per week for 8 weeks. The combined training program will include two parts, aerobic training and resistance training, and each training session will include four stages of warm-up, aerobic training, resistance training and cooling phase. The warm-up phase also includes: lower extremity stretching exercises and cycling activity at 30% of the maximum heart rate for five minutes. Will do. These exercises start with the lowest intensity (50 to 60% of maximum heart rate) and short duration (10 to 20 minutes) and gradually increase in intensity and duration of exercise in each session. Also, because in these special patients due to dialysis conditions, heart rate responses and blood pressure to exercise are different, the Borg scale is used to determine the intensity of exercise and the progress in intensity and duration of exercise is determined based on patients' perception of exercise pressure. According to the Borg Scale, the training pressure in the first month with the perceived effort (RPE) will be nine to 11, and in the last month the work intensity will reach 12 to 14 RPE. Also, resistance exercises will be performed using resistance bands. These exercises include: movements of opening the knee, bending the thigh, moving the thigh and raising the thigh in a straight position. Each movement will be done once or twice in the first month, two to three times in the second month with 12 to 15 repetitions. The amount of overload for each patient will be done separately by changing the colorant. During both aerobic and resistance training, every five minutes the patient is asked to rate his or her workout pressure and fatigue at that point based on a 20-point Borg pressure scale. In addition, the cooling phase will include two minutes of pedaling at 30% of maximum heart rate and inactive lower limb traction. Intervention 3: Control group: Control group: In the control group, no training and complementary interventions will be performed. Yes - There is a plan to make this available What will be shared: Some of the required data such as subjects' background information as well as some of the outcome data can be shared. When: Access period starts 6 months after the results are published To whom: Researchers working in academic, scientific and industrial institutes Conditions: The published results are unobstructed in case of documented use in scientific articles by mentioning the title and also for justification plans. Where to obtain: By e-mail elhamhosseinzadeh22@gmail.com How to obtain: The applicant must state clear and documented reasons for the use of the data by e-mail. After the necessary checks, the data will be provided to the researcher up to one month after the request. Comments:
public Elham Sargol Hossein Zadeh
No. 1 ,Bagheri22-corner of the Alley,Bagheri Blvd
ZABOL Iran (Islamic Republic of) 9861913113 +98 54 3222 6807 Elhamhosseinzadeh22@gmail.com The University of Sistan and Baluchestan scientific Elham Sargol Hossein Zadeh
No. 1,Bagheri22-corner of the Alley,Bagheri Blvd
ZABOL Iran (Islamic Republic of) 9861913113 +98 54 3222 6807 Elhamhosseinzadeh22@gmail.com University of Sistan and Baluchestan Iran (Islamic Republic of) Hemodialysis 3 times a week Body mass index 35-18/5 kg / m2, At least 6 months on hemodialysis treatment, Absence of severe respiratory and heart failure, chronic inflammatory disease of unknown origin, dementia, cancer, hepatitis B, C, neurological disease, HIV Do not use oral supplements and intravenous nutrition No history of recent surgery in the last quarter Range age 25-55 years 25 years 55 years Both Lack of cooperation of the patient to implement the research protocol, including failure to perform at least two sessions of exercise or lack of supplementation by the patient N18 Chronic kidney disease (CKD) Treatment - Other Rehabilitation N/A Intervention group: In the supplement-activity group, the subjects were trained for 8 weeks at the end of each dialysis session (3 sessions per week). Or 24 grams in 150 cc of water will be consumed after each dialysis session Intervention group: In the experimental group, the program will perform combined exercises during dialysis, three sessions per week for 8 weeks. The combined training program will include two parts, aerobic training and resistance training, and each training session will include four stages of warm-up, aerobic training, resistance training and cooling phase. The warm-up phase also includes: lower extremity stretching exercises and cycling activity at 30% of the maximum heart rate for five minutes. Will do. These exercises start with the lowest intensity (50 to 60% of maximum heart rate) and short duration (10 to 20 minutes) and gradually increase in intensity and duration of exercise in each session. Also, because in these special patients due to dialysis conditions, heart rate responses and blood pressure to exercise are different, the Borg scale is used to determine the intensity of exercise and the progress in intensity and duration of exercise is determined based on patients' perception of exercise pressure. According to the Borg Scale, the training pressure in the first month with the perceived effort (RPE) will be nine to 11, and in the last month the work intensity will reach 12 to 14 RPE. Also, resistance exercises will be performed using resistance bands. These exercises include: movements of opening the knee, bending the thigh, moving the thigh and raising the thigh in a straight position. Each movement will be done once or twice in the first month, two to three times in the second month with 12 to 15 repetitions. The amount of overload for each patient will be done separately by changing the colorant. During both aerobic and resistance training, every five minutes the patient is asked to rate his or her workout pressure and fatigue at that point based on a 20-point Borg pressure scale. In addition, the cooling phase will include two minutes of pedaling at 30% of maximum heart rate and inactive lower limb traction. Control group: Control group: In the control group, no training and complementary interventions will be performed Serum levels of interleukin-6. Timepoint: Measurement of interleukin-6 levels at the beginning of the study and after 8 weeks of protocol implementation. Method of measurement: Using blood samples with ELISA technique. Serum levels of hepcidin. Timepoint: Measurement of hepcidin levels at the beginning of the study and after 8 weeks of protocol implementation. Method of measurement: Using blood samples with ELISA technique. Glycemic indexes include fasting blood sugar, insulin and insulin resistance. Timepoint: Measurement at the beginning of the study and after 8 weeks of protocol implementation. Method of measurement: Using blood samples with ELISA technique. Lipid profile. Timepoint: Measurement at the beginning of the study and after 8 weeks of protocol implementation. Method of measurement: Using blood samples with ELISA technique. Kidney function indicators. Timepoint: Measurement at the beginning of the study and after 8 weeks of protocol implementation. Method of measurement: Using blood samples with ELISA technique. Serum iron levels. Timepoint: Measurement at the beginning of the study and after 8 weeks of protocol implementation. Method of measurement: Using blood samples with ELISA technique. Serum ferritin level. Timepoint: Measurement at the beginning of the study and after 8 weeks of protocol implementation. Method of measurement: Using blood samples with ELISA technique. The rate of malnutrition. Timepoint: At the beginning of the study and after 8 weeks of protocol implementation. Method of measurement: Using the Malnutrition-Inflammation Questionnaire. Percentage of body fat. Timepoint: At the beginning of the study and after the end of the study. Method of measurement: Using a caliper. Faculty of Sports Sciences Approved 2022-01-12 Ethics Committee of Sistan and Baluchestan University Zahedan, Daneshjoo St. Daneshjoo 76 zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)