An interventional study of Physical Therapy Exercise Program in End-stage Renal Disease (ESRD), Chronic Kidney Disease and Hemodialysis Patients, sponsored by Mohammad Arian. Recruiting at 1 site in Kuwait. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Mohammad Arian · Not applicable, Interventional, and Treatment
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 72 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →This is the only study on the registry with Mohammad Arian as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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).
Six-Minute Walk Test (6MWT)
Assessment of functional exercise capacity by measuring the total distance walked in six minutes.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, every 4 weeks during the 3-month intervention period, and at 6-month follow-up
Hemoglobin Level
Measurement of hemoglobin concentration from blood samples.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum Potassium Level
Measurement of serum potassium concentration.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum Sodium Level
Measurement of serum sodium concentration obtained from routine blood samples.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum Calcium Level
Measurement of serum calcium concentration obtained from routine blood samples.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum Phosphorus Level
Measurement of serum phosphorus concentration obtained from routine blood samples.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Mar 2025 (actual). Primary completion is estimated for Mar 2027, 24 months after the start.
Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 24 months is close to that.
Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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