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IRCT20181108041594N1 IRCT 2019-01-04 Sabzevar University of Medical Sciences Comparison the effect of cool dialysate and stretching exercises on restless leg syndrome in dialysis patients Comparison the effect of cool dialysate and stretching exercises on restless leg syndrome in patients undergoing hemodialysis with chronic renal failure 2018-12-07 anticipated 60 Complete https://irct.ir/trial/35130 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples are selected according to the eligibility criteria and then they randomly are assigned in two groups with 30 patients, the stretching exercises group (by performing hemodialysis with dialysis solution temperature 37) and cold dialysate group (performing hemodialysis with dialysis solution 35/5) using the Permutation blocks method. The control group is marked with the letter a and the intervention group with the letter b and the size of each block is 4, and the number of blocks is 15 and the number of possible permutations is 4. Then from the random number table or using the simulation command in the application R (runif(15,min=1,max=4)، fifteen random numbers selected and fill 15 blocks of states.So the first four person who enter the study the first person receiving treatment b, the second treatment a, the third person receiving treatment b, and the fourth person receiving treatment a.second Four person who enter the study the first person receiving treatment b, the second treatment b, the third person receiving treatment a, and the fourth person receiving treatment a . Fifteenth four person who enter the study the first person receiving treatment b, the second treatment a, the third person receiving treatment b, and the fourth person receiving treatment a. In this study Patients are not blind. The researcher will be blinded by completing the questionnaires by researcher assistant. And data analyzers will be blinded by patient encoding. , Blinding description: In this study Patients are not blind.The researcher will be blinded by completing the questionnaires by researcher assistant. And data analyzers will be blinded by patient encoding. N/A Restless leg syndrome. Intervention 1: Intervention group 1:Among patients with restless leg syndrome, a group of 30 patients is selected as the cold dialysis solution group. And they will undergo cold hemodialysyis (35.5 ° C ) 4 hours at each session, for 6 weeks. Intervention 2: Intervention group 2: Among patients with restless leg syndrome, 30 patients undergo stretching exercises and for 6 weeks 3 times a week for half an hour in the first 2 hours of dialysis, stretching exercises including pelvic to the sides, Quadriceps muscle stretching, stretching of the muscle of the gluteal muscle , Pulling the hamstrings and pulling the knee to the chest. The dialysis temperature for the group is the same as the standard solution temperature (37 ° C). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Mostafa Rad
Block B, Pardis of Sabzevar University of Medical Sciences, Road Tohid Shahr
Sabzevar Iran (Islamic Republic of) 9613873119 +98 51 4401 8314 mostafarad633@yahoo.com Sabzevar University of Medical Sciences scientific Mostafa Rad
Block B, Pardis of Sabzevar University of Medical Sciences, Road Tohid Shahr
Sabzevar Iran (Islamic Republic of) 9613873119 +98 51 4401 8314 mostafarad633@yahoo.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Having informed consent to participate in the study Age over 18 and up to 71 years Patients with a minimum hemoglobin of 10 mg / dL Patient diagnosed with chronic renal failure who has been undergoing hemodialysis for 3 months Patients with arteriovenous fistula for hemodialysis Patients undergoing hemodialysis three times a week and each session are 4 hours Patients who have had Hemodialysis over the past 2 months have had a history of restless leg syndrome during Hemodialysis Patients with adequacy of dialysis more or equal 1 18 years 71 years Both Hearing and visual impairment Taking medication or food that exacerbates restless leg syndrome during dialysis Pregnancy and the presence of liver problems Receiving treatments that are effective on restless leg syndrome during dialysis (complementary medicine, acupuncture and topical conditioners) The presence of any infection and ulcers in the legs Having orthopedic problems Having vascular problems in the lower extremities Severe mental illness and mood disorder - severe emotional disturbance that prevents effective communication. Patient with hypercalcemia and hypocalcemia G25.81 Restless legs syndrome Treatment - Other Treatment - Other Intervention group 1:Among patients with restless leg syndrome, a group of 30 patients is selected as the cold dialysis solution group. And they will undergo cold hemodialysyis (35.5 ° C ) 4 hours at each session, for 6 weeks. Intervention group 2: Among patients with restless leg syndrome, 30 patients undergo stretching exercises and for 6 weeks 3 times a week for half an hour in the first 2 hours of dialysis, stretching exercises including pelvic to the sides, Quadriceps muscle stretching, stretching of the muscle of the gluteal muscle , Pulling the hamstrings and pulling the knee to the chest. The dialysis temperature for the group is the same as the standard solution temperature (37 ° C). Restless legs syndrome. Timepoint: The measurements of restless leg syndrome are at the beginning of the study before the start of the intervention and then at the end of each week after the completion of the dialysis for 6 weeks. Method of measurement: The severity of restless leg syndrome questionnaire. Sabzevar University of Medical Sciences Approved 2018-11-11 Ethics Committee of Sabzevar University of Medical Sciences Block B, Pardis of Sabzevar University of Medical Sciences, Road Tohid Shahr Sabzevar Razavi Khorasan Iran (Islamic Republic of)