NCT07361146 A Comparative Study of Intradialytic vs. Pre-Dialysis Physical Therapy Interventions in Individuals Undergoing Hemodialysis: A Randomized Controlled Trial
| NCT ID | NCT07361146 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mohammad Arian |
| Condition | End-stage Renal Disease (ESRD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-03-02 |
| Primary Completion | 2027-03-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2025-03-02 with a primary completion date of 2027-03-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07361146 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying End-stage Renal Disease (ESRD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07361146 currently recruiting?
Yes, NCT07361146 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mohammad Arian to inquire about joining.
Where is the NCT07361146 trial being conducted?
This trial is being conducted at Hawalli, Kuwait.
Who is sponsoring the NCT07361146 clinical trial?
NCT07361146 is sponsored by Mohammad Arian. The trial plans to enroll 72 participants.