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IRCT20251208068248N1 IRCT 2026-05-04 Tehran University of Medical Sciences A comparative evaluation of the effects of Intradialytic versus Interdialytic exercises on clinical outcomes in Hemodialysis patients A comparative evaluation of the effects of Intradialytic versus Interdialytic exercises on clinical outcomes in Hemodialysis patients 2026-05-05 anticipated 50 Recruiting https://irct.ir/trial/88081 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: This study is a crossover clinical trial without an independent control group, conducted on patients with end-stage chronic kidney disease undergoing maintenance hemodialysis in the hemodialysis centers of Imam Khomeini, Amir Alam, and Shariati hospitals affiliated with Tehran University of Medical Sciences. Sampling will be done using the convenience sampling method, and 50 eligible patients will be selected based on inclusion and exclusion criteria. The random sequence will be generated using a random number table, and allocation of patients to groups A and B will be performed using sealed opaque and numbered envelopes. N/A The condition under study is end‑stage renal disease (ESRD), defined as the final stage of chronic kidney disease where kidney function is severely reduced and patients require regular hemodialysis to sustain life.. Intervention 1: First intervention group (Intradialytic exercise): Exercise is performed during the first two hours of the dialysis session. The program includes 5 minutes of warm-up (lower limb stretching), aerobic exercise using a stationary bedside bicycle for 10 to 30 minutes at light to moderate intensity, resistance exercises (leg raising, squeezing a small ball between the knees, knee extension, gastrocnemius muscle strengthening with exercise bands, adduction and abduction with ankle weights and resistance bands), and 5 minutes of cool-down (lower limb stretching). These exercises are performed for 4 to 8 weeks during each dialysis session (three times per week). Intervention 2: Second intervention group (Interdialytic exercise): Exercise is performed at home on non-dialysis days. The program includes 5 minutes of warm-up (lower limb stretching), aerobic walking for 15 to 30 minutes at light to moderate intensity, resistance exercises (leg raising, squeezing a small ball between the knees, knee extension, gastrocnemius muscle strengthening with exercise bands, toe standing, adduction and abduction with ankle weights and resistance bands, wall-assisted squats after 2 weeks and unassisted squats after 1 month), balance exercises (single-leg standing, and after 3 weeks single-leg standing with eyes closed), and 5 minutes of cool-down (lower limb stretching). These exercises are performed for 4 to 8 weeks, three times per week. Intervention 3: Control group: This study is a crossover clinical trial without an independent control group. Each patient receives both interventions in two separate periods, and a 4-week washout period without any structured exercise program is considered as the washout phase between the two interventions. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of patient information and the ethical commitment stated in the informed consent form regarding not sharing individual participant data, there is no plan to publish IPD. The research results will only be published as aggregate and group data.
public AliReza Yaghoubi
No. 1470, North Kargar Street, opposite 16th Street (Farshi Moghaddam), Tehran
Tehran Iran (Islamic Republic of) 1439957181 +98 31 4542 4954 alirezayaghoubi.ccn@gmail.com Tehran University of Medical Sciences scientific AliReza Yaghoubi
No. 1470, North Kargar Street, opposite 16th Street (Farshi Moghaddam), Tehran
Tehran Iran (Islamic Republic of) 1439957181 +98 31 4542 4954 alirezayaghoubi.ccn@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) The patient is undergoing regular chronic hemodialysis; at least 12 hours per week. History of at least 3 months of regular dialysis. Body Mass Index (BMI) higher than 18.5 kg/m² and lower than 35 kg/m². Obtaining permission from the attending physician to participate in the study. Willingness and informed consent to participate in the research. 18 years 65 years Both History of MI in the past 3 months. Musculoskeletal disorders or movement limitations that prevent exercise. Amputation. Presence of vascular access whose function is dependent on body position and risk of bleeding during exercise. Uncompensated heart failure. Uncontrolled hypertension. Severe neurological abnormalities. Lack of access to a treadmill and stationary bike at home for performing the exercises. N18.6 End stage renal disease Rehabilitation Rehabilitation N/A First intervention group (Intradialytic exercise): Exercise is performed during the first two hours of the dialysis session. The program includes 5 minutes of warm-up (lower limb stretching), aerobic exercise using a stationary bedside bicycle for 10 to 30 minutes at light to moderate intensity, resistance exercises (leg raising, squeezing a small ball between the knees, knee extension, gastrocnemius muscle strengthening with exercise bands, adduction and abduction with ankle weights and resistance bands), and 5 minutes of cool-down (lower limb stretching). These exercises are performed for 4 to 8 weeks during each dialysis session (three times per week) Second intervention group (Interdialytic exercise): Exercise is performed at home on non-dialysis days. The program includes 5 minutes of warm-up (lower limb stretching), aerobic walking for 15 to 30 minutes at light to moderate intensity, resistance exercises (leg raising, squeezing a small ball between the knees, knee extension, gastrocnemius muscle strengthening with exercise bands, toe standing, adduction and abduction with ankle weights and resistance bands, wall-assisted squats after 2 weeks and unassisted squats after 1 month), balance exercises (single-leg standing, and after 3 weeks single-leg standing with eyes closed), and 5 minutes of cool-down (lower limb stretching). These exercises are performed for 4 to 8 weeks, three times per week. Control group: This study is a crossover clinical trial without an independent control group. Each patient receives both interventions in two separate periods, and a 4-week washout period without any structured exercise program is considered as the washout phase between the two interventions. Primary Outcome Variables: 1) Dialysis adequacy: Dialysis adequacy measured by Kt/V index, extracted from the patient's monthly laboratory results. 2) Inflammatory factors: Levels of ESR (mm/hour) and CRP (mg/L) measured through blood testing. 3) Nutritional factors: Levels of albumin (g/dL), blood urea nitrogen (mg/dL), serum creatinine (mg/dL), serum cholesterol (mg/dL), sodium (mEq/L), potassium (mEq/L), phosphorus (mg/dL), and calcium (mg/dL) measured through blood testing. Timepoint: Data will be collected in four stages: 1) before the first intervention (baseline), 2) at the end of the first period (week 4 or 8), 3) at the end of the washout period (week 8 or 12), 4) at the end of the second period (week 12 or 20). Method of measurement: 1) Dialysis adequacy: Kt/V index calculated from the patient's monthly laboratory results 2) Inflammatory factors: Blood test (measurement of ESR and CRP levels) 3) Nutritional factors: Blood test (measurement of albumin, blood urea nitrogen, serum creatinine, serum cholesterol, sodium, potassium, phosphorus, and calcium levels). Secondary Outcome Variables: 1) Quality of life: Quality of life score measured by the standard KDQOL-SF questionnaire (5-point Likert scale, range 0-100). Higher scores indicate better quality of life. 2) Independence in activities of daily living: Independence score in 6 basic daily activities measured by the Katz ADL index (range 0-6). Higher scores indicate greater independence. 3) Sleep quality: Sleep quality score measured by the PSQI questionnaire (range 0-21). A score higher than 5 indicates sleep disturbance. 4) Patient preferences: Patient preference for each of the two exercise methods measured by a researcher-made questionnaire (Likert scale). Timepoint: Data will be collected in four stages: 1) before the first intervention (baseline), 2) at the end of the first period (week 4 or 8), 3) at the end of the washout period (week 8 or 12), 4) at the end of the second period (week 12 or 20). Method of measurement: 1) Quality of life: Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire 2) Independence in activities of daily living: Katz Index of Independence in Activities of Daily Living (Katz ADL) 3) Sleep quality: Pittsburgh Sleep Quality Index (PSQI) questionnaire 4) Patient preferences: Researcher-made questionnaire with Likert scale. Tehran University of Medical Sciences Approved 2026-01-08 Ethics Committee of the Faculty of Nursing and Midwifery and the Faculty of Rehabilitation - Tehran No. 1470, North Kargar Street, opposite 16th Street (Farshi Moghaddam), Tehran Tehran Tehran Iran (Islamic Republic of)