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

Mohammad Arian

Status: Enrolling

Conditions: Chronic Kidney Disease; Hemodialysis Patients; Physical Rehabilitation During Dialysis; End-stage Renal Disease (ESRD)

Treatments: Behavioral: Physical Therapy Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07361146

IRB-2024-2681 (Other Identifier)

2024/2681

Details and patient eligibility

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Intradialytic Physical Therapy (During Dialysis)

Experimental group

Description:

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).

Treatment:

Behavioral: Physical Therapy Exercise Program

Pre-Dialysis Physical Therapy (Before Dialysis)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Physical Therapy Exercise Program