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NCT Number: NCT07361146

A Comparative Study of Intradialytic vs. 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Therapy Exercise Program

Behavioral

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Hemoglobin Level

    Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

    Measurement of hemoglobin concentration from blood samples.

  2. Serum Potassium Level

    Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

    Measurement of serum potassium concentration.

  3. Serum Sodium Level

    Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

    Measurement of serum sodium concentration obtained from routine blood samples.

  4. Serum Calcium Level

    Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

    Measurement of serum calcium concentration obtained from routine blood samples.

  5. Serum Phosphorus Level

    Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

    Measurement of serum phosphorus concentration obtained from routine blood samples.

Sponsors and collaborators

Lead sponsor

Mohammad Arian

Other Gov

Registry information

Official study title

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

Acronym: DIAL-PT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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