Actively Recruiting

Phase Not Applicable
Age: 21Years - 65Years
All Genders
NCT07361146

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

Led by Mohammad Arian · Updated on 2026-01-22

72

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged between 21 and 65 years
  • Diagnosed with end-stage renal disease (ESRD)
  • Undergoing maintenance hemodialysis for at least 3 months
  • Medically stable and cleared by the nephrologist to participate in moderate physical exercise
  • Able to understand and follow verbal instructions and provide informed consent
Not Eligible

You will not qualify if you...

  • Uncontrolled hypertension, recent myocardial infarction, or unstable angina
  • Severe musculoskeletal, neurological, or cardiovascular disorders that limit physical activity
  • Active infection, fever, or open wounds
  • Recent hospitalization within the past month
  • Participation in any other structured exercise program within the last 3 months

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Hawalli, Kuwait

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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