Chronic Kidney Disease, End-stage Renal Disease (ESRD), Hemodialysis Patients, Physical Rehabilitation During Dialysis
Conditions
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.
Interventions
BEHAVIORALPhysical 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).
Sponsors
Mohammad Arian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-Minute Walk Test (6MWT) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Level | Baseline, 4 weeks, 8 weeks, and 12 weeks | Measurement of hemoglobin concentration from blood samples. |
| Serum Potassium Level | Baseline, 4 weeks, 8 weeks, and 12 weeks | Measurement of serum potassium concentration. |
| Serum Sodium Level | Baseline, 4 weeks, 8 weeks, and 12 weeks | Measurement of serum sodium concentration obtained from routine blood samples. |
| Serum Calcium Level | Baseline, 4 weeks, 8 weeks, and 12 weeks | Measurement of serum calcium concentration obtained from routine blood samples. |
| Serum Phosphorus Level | Baseline, 4 weeks, 8 weeks, and 12 weeks | Measurement of serum phosphorus concentration obtained from routine blood samples. |
Countries
Kuwait
Outcome results
None listed