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IRCT20200819048461N3 IRCT 2023-01-09 Pardis Specialized Wellness Institute Effect of exercise in Peritoneal dialysis The effect of exercises with Therabands and core stability on back pain and quality of life in patients with chronic renal failure undergoing peritoneal dialysis 2023-01-20 anticipated 30 Complete https://irct.ir/trial/67479 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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: Due to the nature of the intervention, it is not plausible to blind participants and study staff who enroll participants and monitor the intervention delivery. Research project collaborator who is blinded to study arm assignments will obtain outcome measurements of the functional test and abnormalities. Outcome adjudicators, and data analysts will be kept blinded to the allocation. N/A End stage renal disease. Intervention group: Intervention group: The experimental group will do 3 sessions of 30-minute exercise program at home for 8 weeks with the simultaneous supervision of the trainer online. These exercises are taught face-to-face in the first week. The training program will include general body warm-up (5 minutes), central stability exercises and general body cooling (10 minutes). After each exercise, a 30 to 60 second rest is given to the patient. Resistance exercises will be done with body weight, special bands, dumbbells, ankle and wrist weights. 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: Dr. Mohammad Ali Tabibi via email address m.tabibi@ut.ac.ir How to obtain: It will be answered within one month after receiving the email Comments:
public Dr Mohammad Ali Tabibi
71 Alley, Jey Street Esfahan
Esfahan Iran (Islamic Republic of) 8174757536 031335252020 m.tabibi@ut.ac.ir Pardis Specialized Wellness Institute scientific Dr Mohammad Ali TabibI
71 Alley, Jey Street, Esfahan
Esfahan Iran (Islamic Republic of) 8174757536 031335252020 m.tabibi@ut.ac.ir Pardis Specialized Wellness Institute Iran (Islamic Republic of) More than 3 months of peritoneal dialysis experience Having chronic back pain The permission of the attending physician to practice No history of heart attack or stroke in the last 3 months Able to walk without assistance (assistive devices such as canes and walkers are allowed). 30 years 75 years Both Unstable blood pressure Changing the type of dialysis Uncontrolled arrhythmias Congestive heart failure Having severe musculoskeletal pain at rest or minimal activity N18.5 Chronic kidney disease, stage 5 Treatment - Other Intervention group: Intervention group: The experimental group will do 3 sessions of 30-minute exercise program at home for 8 weeks with the simultaneous supervision of the trainer online. These exercises are taught face-to-face in the first week. The training program will include general body warm-up (5 minutes), central stability exercises and general body cooling (10 minutes). After each exercise, a 30 to 60 second rest is given to the patient. Resistance exercises will be done with body weight, special bands, dumbbells, ankle and wrist weights Back pain score. Timepoint: Before starting exercise and two months later. Method of measurement: Brief Pain Inventory Questionnaire. Quality of life score. Timepoint: Before starting exercise and two months later. Method of measurement: Short form 36 Questionnaire. Pardis Specialized Wellness Institute Approved 2022-04-20 Research Ethics Committee of Arak University of Medical Sciences Arak University, Karbala Boulevard, Basij Square, Arak Arak Markazi Iran (Islamic Republic of)