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IRCT20230704058663N1 IRCT 2023-08-16 Esfahan University of Medical Sciences Investigating the effect of exercise during dialysis on blood phosphorus and urea clearance Investigating the effect of active exercise during dialysis on uremia and hyperphosphatemia in hemodialysis patient 2023-08-23 anticipated 66 Complete https://irct.ir/trial/71104 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: The groups participating in the study receive an independent intervention or no intervention (control group), Randomization description: The replacement of samples in the groups will be done in the form of random allocation using the minimization method. Minimization is done using MiniPie software (http://minimpy.sourceforge.net). Considering the fact that the distribution of urea in the body of patients undergoing hemodialysis (distribution volume of urea) depends on the age, gender, height and weight of the patient, therefore the parameters of age, gender, height and weight for the random allocation of samples in the soft Software will be defined. After selecting the samples in an easy way, the research associate will give a unique number to the sample and after entering the defined variables into the software, the application will place the patient in the test or control group. In other words, the information of 66 patients enters the software, the software will place 33 patients in the test group and 33 patients in the control group. If the software puts a patient with a certain age, sex, height and weight in the test group, it tries to put a similar patient in the control group in terms of the mentioned characteristics, and if there is no similar sample in the 66 entered list. Sampling will continue until the desired number of samples is provided in both groups and the samples are homogeneous, Blinding description: It is not possible to be blinded by the researcher and the samples, but blinding will be done by the analyst or statistician. N/A Condition 1: Hyperphosphatemia. Condition 2: Uremia. Intervention 1: Intervention group: Intervention group: They will perform an exercise program including active range of motion exercises for 2 weeks and then pedaling a stationary bike or a mini bike for 6 weeks during dialysis. The suggested duration of exercise in each session will gradually increase depending on the patient's ability. Exercise intensity is also measured using standard tools. Intervention 2: Control group: receive routine care during dialysis, including control of vital signs, self-care training, care of vascular access, daily visit of a specialist doctor, nutritional advice, daily weighing in each dialysis session. Yes - There is a plan to make this available What will be shared: Information on the main outcome will be shared. When: The access period starts 6 months after the results are published To whom: The request of all the people who want to access the data will be answered. Conditions: In order to use the protocol in the hospital, to implement the protocol in rehabilitation centers, in cases where it has a supportive and therapeutic aspect for the patient, mention the study results in other researches. Where to obtain: Respondent: Elham Hasani Email address: eli.hsni1996@gmail.com How to obtain: After receiving the email, it will be answered within 48 hours. Comments:
public Elham Hasani
12 Shohada Alley, Shohada St.
Lordegan Iran (Islamic Republic of) 88916-83915 +98 38 3444 9589 eli.hsni.1996@gmail.com Esfahan University of Medical Sciences scientific Elham Hasani
12 Shohada Alley, Shohada St.
Lordegan Iran (Islamic Republic of) 88916-83915 +98 38 3444 9589 eli.hsni.1996@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) All dialysis patients who are over 18 years old. All dialysis patients who have a fixed number of sessions per week and undergo hemodialysis 3 times a week and each session lasts for 4 hours. All dialysis patients who have undergone hemodialysis for more than 3 months. All dialysis patients who use a permanent vascular access. All dialysis patients who are able to perform active range of motion exercises and pedal independently. All dialysis patients who have the ability to learn exercises and do not have mental disabilities. All dialysis patients who had stable hemodynamics during hemodialysis sessions in the last 1 month. 18 years no limit Both pregnancy. Patients with symptomatic and severe aortic stenosis Patients who have a history of lung disease that requires oxygen therapy Patients who do not have a history of stroke or transient ischemic attacks in the last 3-6 months Patients who have a history of heart attack and unstable angina in the past 3-6 months. Patients with a history of ischemic heart disease Patients who have any disorders in the musculoskeletal system (orthopedic problems, lower limb amputations, etc.) that prevent them from performing the desired sports activities Patients with uncontrolled blood pressure. Patients with uncontrolled diabetes. Patients who have a history of moderate to severe heart failure (class ≥II according to New York Heart Association criteria). Patients with a history of angina pectoris grade 2-4 according to the criteria of the Canadian Heart and Vascular Association N18.5 N18.5 Chronic kidney disease, stage 5 Chronic kidney disease, stage 5 N/A N/A Intervention group: Intervention group: They will perform an exercise program including active range of motion exercises for 2 weeks and then pedaling a stationary bike or a mini bike for 6 weeks during dialysis. The suggested duration of exercise in each session will gradually increase depending on the patient's ability. Exercise intensity is also measured using standard tools. Control group: receive routine care during dialysis, including control of vital signs, self-care training, care of vascular access, daily visit of a specialist doctor, nutritional advice, daily weighing in each dialysis session. Blood phosphorus level. Timepoint: At the beginning of the study (before the start of the intervention) and 1 and 2 months after the start of the intervention. Method of measurement: Sending the blood sample to the laboratory. Blood urea level. Timepoint: At the beginning of the study (before the start of the intervention) and 1 and 2 months after the start of the intervention. Method of measurement: Sending the blood sample to the laboratory. Quality of life. Timepoint: mortality. Method of measurement: hospitalization. Esfahan University of Medical Sciences Approved 2023-06-26 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib Street, Isfahan University of Medical Sciences, Building No. 3, Faculty of Medicine, Ground Floor, Department of Medical Ethics Isfahan Isfehan Iran (Islamic Republic of)