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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Kuwait
Mubarak Al-Abdullah Al-Jaber Al-Sabah Dialysis Center
RECRUITING
Hawalli
Time Frame
Start Date: 2025-03-02
Estimated Completion Date: 2027-06-02
Participants
Target number of participants: 72
Treatments
Experimental: Intradialytic Physical Therapy (During Dialysis)
Participants in this group will perform supervised physical therapy exercises during dialysis sessions twice weekly for 12 weeks (approximately 30 minutes each session, including warm-up, resistance training, and cool-down).
Active_comparator: Pre-Dialysis Physical Therapy (Before Dialysis)
Participants in this group will perform supervised physical therapy exercises before dialysis sessions twice weekly for 12 weeks, following the same exercise protocol and duration as the intradialytic group.
Related Therapeutic Areas
Sponsors
Leads: Mohammad Arian

This content was sourced from clinicaltrials.gov