End-stage Renal Disease (ESRD)DIAL-PTNCT07361146

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

A study testing Physical Therapy Exercise Program in people with End-stage Renal Disease (ESRD) and Chronic Kidney Disease, run by Mohammad Arian at 1 site in Kuwait.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 to 65 years
Conditions the study is for: End-stage Renal Disease (ESRD), Chronic Kidney Disease, Hemodialysis Patients
What is being tested?: Physical Therapy Exercise Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteKuwait
Study dates: 2 Mar 2025to 2 Jun 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kuwait1 site, 1 recruiting

Mubarak Al-Abdullah Al-Jaber Al-Sabah Dialysis Center
Hawalli
Mohammad I Arian, bachelor, +96597468075, m.arian@moh.gov.kw
Recruiting

Other trials in Kuwait

About this study

Official title: 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.

Conditions: End-stage Renal Disease (ESRD), Chronic Kidney Disease, Hemodialysis Patients, Physical Rehabilitation During Dialysis
Being tested: Physical Therapy Exercise Program
Medical subject headings: Kidney Failure, Chronic, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physical Therapy Exercise ProgramBehavioural
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).

Study groups in NCT07361146
Study group	Role	What they receive
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). Receives: 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. Receives: Behavioral: Physical Therapy Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Six-Minute Walk Test (6MWT)
Assessment of functional exercise capacity by measuring the total distance walked in six minutes.
Measured: 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.
Measured: 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.
Measured: Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 20252 Jun 2027

First posted22 Jan 2026
Study start2 Mar 2025
Primary completion2 Mar 2027 (estimated)
Study completion2 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for End-stage Renal Disease (ESRD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 72 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07361146
Sponsor's protocol ID: 2024/2681
Other IDs: IRB-2024-2681
Acronym: DIAL-PT
Status last verified: Jan 2026
First submitted: 6 Jan 2026
Last updated: 22 Jan 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Recruiting
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
End Stage Renal Disease (ESRD), Kidney Failure
Enrolling by invitationObservational study
Blood Volume Monitoring Via Critline in Volume Overload: Hospitalization and Readmission
End Stage Renal Disease (ESRD), Volume Overload
RecruitingPhase 1/2
Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD
ESRD (End-Stage Renal Disease), Kidney Transplantation
Not yet recruitingObservational study
DKK3 as a Biomarker of Peritoneal Fibrosis in Peritoneal Dialysis Patients
Peritoneal Dialysis (PD), End Stage Renal Disease (ESRD)

All End-stage Renal Disease (ESRD) trials