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.
Trial 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). Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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
- Recruiting
Mubarak Al-Abdullah Al-Jaber Al-Sabah Dialysis Center
Hawalli
Mohammad I Arian, bachelor, +96597468075, m.arian@moh.gov.kw
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.
Read more
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Mohammad Arian
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Mohammad Arian, Ministry of Health, Kuwait
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Intradialytic Versus Pre-Dialysis Physical Therapy Interventions in Individuals Undergoing Hemodialysis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07361146
- Acronym / sponsor ID
- DIAL-PT / 2024/2681
- Conditions
- End-stage Renal Disease (ESRD), Chronic Kidney Disease, Hemodialysis Patients, Physical Rehabilitation During Dialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Mohammad ArianOther government
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- 2 Mar 2027 (estimated)
- Study completion
- 2 Jun 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradialytic Physical Therapy (During Dialysis) | Experimental | Behavioral: Physical Therapy Exercise ProgramParticipants 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). |
| Pre-Dialysis Physical Therapy (Before Dialysis) | Active comparator | Behavioral: Physical Therapy Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Therapy Exercise ProgramA structured physical therapy program including warm-up, strengthening, balance, and stretching exercises delivered either during or before hemodialysis sessions (twice weekly for 12 weeks). | Behavioural | Intradialytic Physical Therapy (During Dialysis), Pre-Dialysis Physical Therapy (Before Dialysis) |
Primary outcome
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.
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.
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.
5 secondary outcomes
Hemoglobin Level
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum Potassium Level
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum Sodium Level
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum Calcium Level
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum Phosphorus Level
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-Minute Walk Test (6MWT) (time frame: Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.