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

NCT07361146 | Recruiting

• 2 other identifiers: 2024/2681IRB-2024-2681
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Six-Minute Walk Test (6MWT)

  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)

  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)

  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 Outcomes (5)

• Hemoglobin Level

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Serum Potassium Level

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Serum Sodium Level

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Serum Calcium Level

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Serum Phosphorus Level

  Baseline, 4 weeks, 8 weeks, and 12 weeks

Study Arms (2)

Intradialytic Physical Therapy (During Dialysis)

EXPERIMENTAL

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

Pre-Dialysis Physical Therapy (Before Dialysis)

ACTIVE COMPARATOR

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

Interventions

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).

Intradialytic Physical Therapy (During Dialysis); Pre-Dialysis Physical Therapy (Before Dialysis)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohammad Arian: lead

Study Sites (1)

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

Hawalli, Kuwait

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 22, 2026
• Study Start: March 2, 2025
• Primary Completion (Estimated): March 2, 2027
• Study Completion (Estimated): June 2, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)