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IRCT20200819048461N2 IRCT 2022-12-21 Islamic Azad University The effect of exercise and curcumin on hemodialysis disease The effect of cimbination of exercise and curcumin supplementation on serum ferritin and serum albumin in hemodialysis patients 2023-01-03 anticipated 80 Complete https://irct.ir/trial/67130 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: En Simple randomization, individual with random number generation program Randomization was performed by a biostatistician using a computer-generated randomization program [using Stata 16, StataCrop, College Station, Tx] with an allocation ratio of 1:1. For allocation concealment, allocation information will be protected in opaque sealed envelopes by an identified individual not participating in the study. Only after participant registration and baseline measurements are completed will envelopes be opened, Blinding description: One of the experimental groups of the research was the exercise + supplement group, which received the supplement in the form of capsules along with doing sports exercises, and the second experimental group was the exercise group, which only exercised and a capsule that looked similar to the supplement capsule but contained He was receiving curcumin. N/A End stage renal disease. Intervention 1: The first intervention group :the experimental group will do 3 sessions of 45-minute exercise program per week at home on non-dialysis days with the simultaneous supervision of an online trainer for 12 weeks. These exercises are taught face-to-face in the first week. resistance exercises (2 sets of 12 repetitions, including anterior and posterior knee strengthening, lateral hip joint strengthening (adductors and abductors), strengthening of the anterior and posterior leg system, rest period between sets 30 to 60 secondsconsidered) aerobic exercise (3 turns of 15 repetitions of walking backwards, walking and turning, walking sideways, stopping on heels and toes, walking on heels and toes and walking on stairs). It is worth mentioning that before and after each training session, the subjects performed static stretching and softening movements to warm up and cool down the body. Intervention 2: The second intervention group :The experimental group will receive curcumin supplements in the form of capsules for 12 weeks, in such a way that these capsules will be delivered to them once every 3 weeks. All capsules will be the same in terms of shape, quantity, size, and color.Theparticipants will be asked to take 2 capsules of curcumin daily (equivalent to 1000 mg of curcumin) preferably after the main meal. Intervention 3: The third intervention group : the exercise group was +supplement. The subjects in this group, along with the exercise group, performed combined exercises, and during the research period, they received 1000 mg of curcumin supplement (manufactured by Dineh company) daily for 12 weeks. Intervention 4: Control group: Subjects in this group did not do any exercise during the research period (12 weeks) and did not receive any supplements. Yes - There is a plan to make this available What will be shared: The results of the study group are made available When: After october 2023 To whom: Only academics are allowed Conditions: If the data is used for the purpose of research in the field of variables and providing new solutions, it can be used by mentioning the source Where to obtain: by email m.tabibi@ut.ac.ir How to obtain: It will be answered within one month after receiving the email Comments:
public Mehsa Soleimani Sadeh
Gulzar 5
Fouladshahr-Maskan Mehr Iran (Islamic Republic of) 8491153979 +98 31 5243 5855 soleymanymahsa1375@gmail.com Islamic Azad University scientific Doctor Mohammad Ali Tabibi
71 alley.Jey street
Esfahan Iran (Islamic Republic of) 8174757536 031335252020 m.tabibi@ut.ac.ir Pardis Specialist Wellness Institute Iran (Islamic Republic of) Age between 18 and 80 years More than three months of dialysis experience Having a three-time hemodialysis program No heart attack and stroke in the past three months Having the ability to communicate with others The permission of the attending physician to practice be clinically stable 18 years 80 years Both Unstable heart condition (angina, congestive heart failure, severe arterial stenosis, uncontrolled arrhythmias, etc.) Active infection or acute medical illness Hemodynamic instability, unstable blood sugar unable to exercise (lower limb amputation without prosthesis) Having severe skeletal-muscular pain at rest or minimal activity Having shortness of breath while resting or with daily activities Allergy or insensitivity to turmeric N18.5 Chronic kidney disease, stage 5 Treatment - Other Placebo Treatment - Other Other The first intervention group :the experimental group will do 3 sessions of 45-minute exercise program per week at home on non-dialysis days with the simultaneous supervision of an online trainer for 12 weeks. These exercises are taught face-to-face in the first week. resistance exercises (2 sets of 12 repetitions, including anterior and posterior knee strengthening, lateral hip joint strengthening (adductors and abductors), strengthening of the anterior and posterior leg system, rest period between sets 30 to 60 secondsconsidered) aerobic exercise (3 turns of 15 repetitions of walking backwards, walking and turning, walking sideways, stopping on heels and toes, walking on heels and toes and walking on stairs). It is worth mentioning that before and after each training session, the subjects performed static stretching and softening movements to warm up and cool down the body. The second intervention group :The experimental group will receive curcumin supplements in the form of capsules for 12 weeks, in such a way that these capsules will be delivered to them once every 3 weeks. All capsules will be the same in terms of shape, quantity, size, and color.Theparticipants will be asked to take 2 capsules of curcumin daily (equivalent to 1000 mg of curcumin) preferably after the main meal. The third intervention group : the exercise group was +supplement. The subjects in this group, along with the exercise group, performed combined exercises, and during the research period, they received 1000 mg of curcumin supplement (manufactured by Dineh company) daily for 12 weeks. Control group: Subjects in this group did not do any exercise during the research period (12 weeks) and did not receive any supplements The normal level of ferritin in serum is between 10 and 300 nanograms per milliliter, and ferritin levels above 200 nanograms per milliliter in women and above 300 nanograms per milliliter in men have been diagnosed as abnormal. Serum ferritin levels in hemodialysis patients measurement of serum ferritin in the bloodstream can be useful for monitoring the progress of hemodialysis disease. Timepoint: Ferritin measurement of the subjects' blood was done in two stages, the first stage in the initial blood sampling, i.e. 24 hours before the start of the exercise protocol and curcumin supplementation, and the second stage in the blood sample of the last stage, three months after the last exercise session and the last curcumin intake a done. Method of measurement: To measure serum ferritin, it was measured and recorded using the ARKA kit by ELISA method (Enzyme-linked immunoadsorbent assay). Serum albumin level, the normal level of serum albumin is between 4.3 and 4.5 grams per deciliter, and hemodialysis patients have low albumin levels. Measuring the amount of serum albumin in the bloodstream can be useful for monitoring the progress of hemodialysis patients. Timepoint: Measuring the blood albumin of the subjects in two stages, the first stage in the initial blood sampling, i.e. 24 hours before the start of the exercise protocol and taking curcumin supplement and the second stage, in the final stage blood sampling, three months after the last session of sports training and the last curcumin intake a done . Method of measurement: The amount of albumin was measured and recorded by the Bionik laboratory kit, using the autoanalyzer olympus model AU made in Iran. Functional status. Timepoint: Before starting exercise and taking curcumin and three months later. Method of measurement: 6-minute walking test. Islamic Azad University of Khorasgan, Isfahan Approved 2022-09-05 Research ethics committee J Sharghi St., Arghavanieh Esfahan Isfehan Iran (Islamic Republic of)