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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-2024-2681 | Other Identifier | MOH Ethics Committee Approval Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Level | Measurement of hemoglobin concentration from blood samples. | Baseline, 4 weeks, 8 weeks, and 12 weeks |
| Serum Potassium Level | Measurement of serum potassium concentration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mubarak Al-Abdullah Al-Jaber Al-Sabah Dialysis Center | Recruiting | Hawalli | Kuwait |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 30, 2024 |
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| Baseline, 4 weeks, 8 weeks, and 12 weeks |
| Serum Sodium Level | Measurement of serum sodium concentration obtained from routine blood samples. | Baseline, 4 weeks, 8 weeks, and 12 weeks |
| Serum Calcium Level | Measurement of serum calcium concentration obtained from routine blood samples. | Baseline, 4 weeks, 8 weeks, and 12 weeks |
| Serum Phosphorus Level | Measurement of serum phosphorus concentration obtained from routine blood samples. | Baseline, 4 weeks, 8 weeks, and 12 weeks |
| Oct 15, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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