RecruitingNot ApplicableNCT07361146

A Comparative Study of Intradialytic vs. Pre-Dialysis Physical Therapy Interventions in Individuals Undergoing Hemodialysis: A Randomized Controlled Trial

A Comparative Study of Intradialytic Versus Pre-Dialysis Physical Therapy Interventions in Individuals Undergoing Hemodialysis: A Randomized Controlled Trial


Sponsor

Mohammad Arian

Enrollment

72 participants

Start Date

Mar 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized controlled trial aims to compare the effectiveness of two different timings of physical therapy for individuals undergoing hemodialysis: intradialytic (during dialysis) and pre-dialysis (before dialysis). The study seeks to determine which approach provides better improvements in physical function, quality of life, and biochemical outcomes such as hemoglobin and electrolyte levels. A total of 72 adult participants with end-stage renal disease (ESRD) receiving hemodialysis will be randomly assigned to one of two groups. Both groups will receive standardized educational sessions on the benefits and safety of exercise before beginning the intervention. Participants in the intradialytic group will perform supervised exercises during their dialysis sessions, while those in the pre-dialysis group will complete similar exercises before their dialysis sessions. Each participant will undergo the intervention twice per week for 12 weeks. Primary outcomes include physical function, assessed using the Six-Minute Walk Test and the Five Times Sit-to-Stand Test. Secondary outcomes include hemoglobin levels, electrolyte balance, and health-related quality of life measured by the KDQOL questionnaire. The study will be conducted at Mubarak Al-Abdullah Al-Jaber Al-Sabah Dialysis Center, Kuwait, following ethical approval from the Ministry of Health Research Ethics Committee. The results are expected to inform best practices for integrating physical therapy into dialysis care to enhance the health, safety, and well-being of individuals undergoing hemodialysis.


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches to exercise for people on hemodialysis: exercising during dialysis sessions versus exercising before dialysis sessions. It aims to find out which approach better improves physical function and quality of life in patients with kidney failure. **You may be eligible if...** - You are between 21 and 65 years old - You have end-stage kidney disease and have been on regular hemodialysis for at least 3 months - You are medically stable and your kidney specialist has cleared you for moderate exercise - You can understand and follow verbal instructions and give consent **You may NOT be eligible if...** - You have uncontrolled high blood pressure, a recent heart attack, or unstable chest pain - You have severe physical conditions (muscle, nerve, or heart problems) that limit exercise - You have an active infection, fever, or open wounds - You were hospitalized in the past month - You are currently in another structured exercise program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPhysical Therapy Exercise Program

A structured physical therapy program including warm-up, strengthening, balance, and stretching exercises delivered either during or before hemodialysis sessions (twice weekly for 12 weeks).


Locations(1)

Mubarak Al-Abdullah Al-Jaber Al-Sabah Dialysis Center

Hawalli, Kuwait

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NCT07361146


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