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.. End stage renal disease
Conditions
Interventions
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 stret
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAliReza Yaghoubi
Tehran University of Medical Sciences
Outcome results
None listed