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

January 14, 2026 updated by: Mohammad Arian

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kuwait
      • Hawalli, Kuwait
        • Recruiting
        • Mubarak Al-Abdullah Al-Jaber Al-Sabah Dialysis Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Behavioral: Physical 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).
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.
Behavioral: Physical 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six-Minute Walk Test (6MWT)
Time Frame: Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up
Assessment of functional exercise capacity by measuring the total distance walked in six minutes.
Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up
Quality of Life (Kidney Disease Quality of Life - KDQOL)
Time Frame: Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up
Quality of life assessed using the Kidney Disease Quality of Life (KDQOL) questionnaire.
Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up
Five Times Sit-to-Stand Test (FTSST)
Time Frame: Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up
Assessment of lower limb strength and functional mobility by measuring the time required to complete five sit-to-stand repetitions.
Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin Level
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Measurement of hemoglobin concentration from blood samples.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum Potassium Level
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Measurement of serum potassium concentration.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum Sodium Level
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Measurement of serum sodium concentration obtained from routine blood samples.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum Calcium Level
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Measurement of serum calcium concentration obtained from routine blood samples.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum Phosphorus Level
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Measurement of serum phosphorus concentration obtained from routine blood samples.
Baseline, 4 weeks, 8 weeks, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohammad Arian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2025

Primary Completion (Estimated)

March 2, 2027

Study Completion (Estimated)

June 2, 2027

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/2681
  • IRB-2024-2681 (Other Identifier: MOH Ethics Committee Approval Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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