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IRCT20150529022466N15 IRCT 2020-05-05 Boushehr University of Medical Sciences The effect of physical activity during dialysis on dialysis adequacy, hemodynamic indicators and fatigue in patients Evaluation of the Effectiveness of Physical Activity During Dialysis on the Dialysis Adequacy, Hemodynamic Indices and Fatigue in Hemodialysis Patients 2020-01-21 anticipated 84 Complete https://irct.ir/trial/44806 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After selecting all available participants based on inclusion criteria, randomization will be done using simple randomization method and statistical software, Blinding description: In the study, each participant will have a code that only the researcher will have access to, and the participant's name will not be specified for the outcomes evaluator and data analyzer. Paraclinical tests performance, record data and enter data into the software for analysis using code and without revealing the study group and name. N/A End Stage Renal Disease (ESRD), Hemodialysis. Intervention 1: Intervention group: Patients with chronic renal failure with at least three months of hemodialysis undergo exercise for thirty minutes in two 15-minute phases during the first two hours of dialysis. The activity is performed using a pedal that is installed at the bottom of the patient's bed. There is an interval of fifteen minutes for rest during activity. Before the intervention, participants warm up for five minutes and then slowly cool off by pedaling. The pedaling intensity will be such that the patient reaches a 10% increase in pulse rate compared to the pulse rate before starting the activity. The safe range of pulse rate in patients at the time of activity is considered to be a minimum of 50 and a maximum of 125 beats per minute. Intervention 2: Control group: Patients with chronic renal failure with at least three months of hemodialysis will undergo 4-hour routine dialysis. 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 Dr. Shahnaz Pooladi
Sabzabad avenue
Bushehr Iran (Islamic Republic of) 7518759577 +98 77 3345 0187 pouladi2008@yahoo.com Boushehr University of Medical Sciences scientific Dr. Shahnaz Pooladi
School of nursing and midwifery, Bushehr University of medical sciences, Rishehr avenue, Sabzabad avenue
Bushehr Iran (Islamic Republic of) 7518759577 +98 77 3345 0187 pouladi2008@yahoo.com Boushehr University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age of 18 to 65 years old History of hemodialysis more than 3 months Ability to perform walking independently (at least 2 minutes) 4-hour dialysis tolerance in past sessions No history of hypokalemia (K<3.5 Meq/L) 18 years 65 years Both Having problems with the musculoskeletal system Systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 120 mmHg Having vascular access in the lower extremities History of unstable angina and heart attack in 1 last month History of congestive heart failure Treatment with psychotropic drugs N18.5 Chronic kidney disease, stage 5 Rehabilitation Other Intervention group: Patients with chronic renal failure with at least three months of hemodialysis undergo exercise for thirty minutes in two 15-minute phases during the first two hours of dialysis. The activity is performed using a pedal that is installed at the bottom of the patient's bed. There is an interval of fifteen minutes for rest during activity. Before the intervention, participants warm up for five minutes and then slowly cool off by pedaling. The pedaling intensity will be such that the patient reaches a 10% increase in pulse rate compared to the pulse rate before starting the activity. The safe range of pulse rate in patients at the time of activity is considered to be a minimum of 50 and a maximum of 125 beats per minute. Control group: Patients with chronic renal failure with at least three months of hemodialysis will undergo 4-hour routine dialysis. Dialysis adequacy which is assessed by measuring the blood urea nitrogen levels before and after dialysis, the amount of fluid excreted from the patient and the weight after dialysis. Timepoint: It is measured before the start of the study and after each dialysis session. Then the average is estimated at the end of the one month study period. Method of measurement: Dialysis adequacy calculation software and Kt / V. Fatigue. Timepoint: Before and after the one month study period. Method of measurement: FSS questionnaire. Blood pressure. Timepoint: Before and after dialysis and at each dialysis session until the end of the study period. Method of measurement: Using a digital device. Pulse. Timepoint: Before and after dialysis and at each dialysis session until the end of the study period. Method of measurement: Using a digital device. Respiratory rate. Timepoint: Before and after dialysis and at each dialysis session until the end of the study period. Method of measurement: Using an examination by a researcher. Tempreture. Timepoint: Before and after dialysis and at each dialysis session until the end of the study period. Method of measurement: Using a digital device. O2 Saturation. Timepoint: Before and after dialysis and at each dialysis session until the end of the study period. Method of measurement: Using a digital device. Boushehr University of Medical Sciences Approved 2019-12-22 Ethics committee of Bushehr University of Medical Sciences Sabzabad Ave. Bushehr Boushehr Iran (Islamic Republic of)