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IRCT20250819066916N1 IRCT 2025-08-29 Esfahan University of Medical Sciences The effect of exercise during dialysis Investigating the effect of stationary cycling exercise during dialysis on dialysis adequacy and laboratory parameters of hemodialysis patients 2025-09-21 anticipated 75 Complete https://irct.ir/trial/85680 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, participants were assigned to the intervention or control group using simple randomization through the Simple Randomize software. Randomization was performed at the individual level, and allocation concealment was ensured by the software so that neither researchers nor participants could predict group assignment prior to enrollment, Blinding description: Due to the nature of the intervention (using a cycle ergometer during hemodialysis), participants cannot be blinded to their group assignment, as the physical experience of the intervention is observable and tangible. However, to minimize bias in data collection and analysis, the following measures were implemented: Clinical caregivers and healthcare personnel responsible for patient care were kept unaware of group allocation, and uniform care protocols were applied to all patients so that the intervention effect could not be distinguished from routine care. Data collection was conducted by a team member who knew the group assignments; however, data were coded and provided to the data analyst in a de-identified manner. The data analyst remained blinded to the group assignment, and all analyses were performed based on anonymized codes. The principal investigator and study conductors had no access to individual group assignments, ensuring that decisions and analyses were independent of group allocation. The Data Safety and Monitoring Committee (DSMC), if applicable, could access anonymized data but no information regarding specific group assignments was disclosed to the analyst or clinical staff. Thus, although participants could not be blinded due to the nature of the intervention, clinical caregivers, data collectors, and the analyst were effectively blinded to minimize potential bias and preserve the validity of the study results. N/A Chronic Kidney Disease. Intervention 1: Intervention group: Patients in the intervention group will undergo intradialytic exercise using a stationary bicycle for 8 weeks (2 months), three sessions per week, concurrently with their hemodialysis. The exercise will be performed on a stationary cycle ergometer available in the dialysis center, positioned next to the patient’s bed. Each session will be conducted during the first two hours of dialysis and will last for 20 minutes. Exercise protocol: 5 minutes of warm-up, two sets of 10 minutes cycling with an initial resistance of 20 watts and intensity adjusted to the patient’s individual capacity, with a 2-minute rest between sets, followed by 5 minutes of cool-down. The exercise intensity will be progressively increased based on the patient’s condition until continuous 20-minute cycling is achieved.All exercise sessions will be supervised by the researcher and the dialysis nurse. If any adverse symptoms such as severe dyspnea, chest pain, hypotension, or marked weakness occur, the exercise will be immediately discontinued. Intervention 2: Control group: Patients in the control group will receive only their routine hemodialysis treatment according to the standard protocol of the center, without any additional exercise intervention. 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 Not yet decided – the data sharing plan is not determined. Note: At this stage, there is no plan to share de-identified individual participant data. The final decision is expected after the study is completed. If sharing is planned, the method, timing, and access conditions will be specified.
public Mohammad Matinfar
Dr. Ali Shariati Hospital, Isfahan, Chaharbagh-e Bala Street, Dr. Ali Shariati Hospital
Isfahan Iran (Islamic Republic of) 8173745384 +98 31 3627 2001 m.matinfar@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Matinfar
Dr. Ali Shariati Hospital, Isfahan, Chaharbagh-e Bala Street, Dr. Ali Shariati Hospital
Isfahan Iran (Islamic Republic of) 8173745384 +98 31 3627 2001 m.matinfar@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age over and equal to 18 years Written informed consent to participate in the study Diagnosis of chronic kidney failure and receiving maintenance hemodialysis for at least 3 months Undergoing at least 3 hemodialysis sessions per week No hospitalization within the past month No diagnosed psychiatric or cognitive disorders Having the physical ability to perform exercise on a stationary bicycle during dialysis 18 years no limit Both Age less than 18 years Lack of written informed consent to participate in the study Not having chronic kidney disease and receiving hemodialysis for less than three months Having fewer than three hemodialysis sessions per week Hospitalization within the past month Have a diagnosed psychiatric or cognitive disorder Not being physically fit enough to exercise on a stationary bike during dialysis N18.5 Chronic kidney disease, stage 5 Rehabilitation Rehabilitation Intervention group: Patients in the intervention group will undergo intradialytic exercise using a stationary bicycle for 8 weeks (2 months), three sessions per week, concurrently with their hemodialysis. The exercise will be performed on a stationary cycle ergometer available in the dialysis center, positioned next to the patient’s bed. Each session will be conducted during the first two hours of dialysis and will last for 20 minutes. Exercise protocol: 5 minutes of warm-up, two sets of 10 minutes cycling with an initial resistance of 20 watts and intensity adjusted to the patient’s individual capacity, with a 2-minute rest between sets, followed by 5 minutes of cool-down. The exercise intensity will be progressively increased based on the patient’s condition until continuous 20-minute cycling is achieved.All exercise sessions will be supervised by the researcher and the dialysis nurse. If any adverse symptoms such as severe dyspnea, chest pain, hypotension, or marked weakness occur, the exercise will be immediately discontinued. Control group: Patients in the control group will receive only their routine hemodialysis treatment according to the standard protocol of the center, without any additional exercise intervention. Dialysis adequacy (Kt/V). Timepoint: Dialysis adequacy (Kt/V) is measured at three time points: baseline, week 4 (mid-study), and week 8 (end of study). Method of measurement: Dialysis adequacy (Kt/V) is calculated by collecting blood samples before and after dialysis and entering the laboratory results and dialysis parameters into the corresponding formula. Laboratory parameters (hemoglobin, creatinine, etc.). Timepoint: Laboratory parameters is measured at three time points: baseline, week 4 (mid-study), and week 8 (end of study). Method of measurement: Laboratory parameters are collected according to standard procedures at the beginning of the dialysis session before starting dialysis from a fasting patient. Hemodynamic parameters (systolic and diastolic blood pressure, pulse, and oxygen saturation). Timepoint: Hemodynamic parameters, including blood pressure, pulse, and oxygen saturation, are monitored at three time points: the beginning of the study, mid-study (week four), and the end of the study (week eight), both before and after dialysis. Method of measurement: Hemodynamic parameters are monitored at the patient’s bedside using calibrated blood pressure monitors and pulse oximeters. Esfahan University of Medical Sciences Approved 2025-08-18 Ethics Committee of Isfahan University of Medical Sciences – Al-Zahra Research Centers No. 4 Building, Vice-Chancellery for Research and Technology, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)