Effect of Intradialytic Blood Flow Restriction Training on Functional Capacity, Estimated Glomerular Filtration Rate and Health Related Quality of Life in Patients on Hemodialysis

Not Applicable

Completed

• Conditions: Blood Flow Restriction Training; Glomerular Filtration Rate; Quality of Life; Hemodialysis

• Registration Number: NCT06976281
• Lead Sponsor: Beni-Suef University

Brief Summary

this study was done to investigate the effect of intradialytic blood flow restriction training on functional capacity, estimated glomerular filtration rate and health related Quality of life in patients on Hemodialysis

Detailed Description

Chronic kidney disease affects 10% to 15% of the population and is characterized by a progressive decline in glomerular filtration rate. The disease can lead to frailty, muscle mass wasting, and sarcopenia, affecting functional mobility and quality-of-life measures. The increased protein catabolism in Chronic kidney disease is partly due to inflammatory status, nutrient loss during dialysis, and musculoskeletal system changes. Assessment of muscle functionality can provide additional diagnostic and prognostic information for clinical outcomes, quality of life, and mortality rates. Exercise training with blood flow restriction is a potential method for clinical musculoskeletal rehabilitation, potentially improving strength, physical function, blood pressure control, glucose homeostasis, autonomic function, renal deterioration, dialysis adequacy, and antioxidant defenses.

Study Timeline

• Study Start: 2024-08-01
• Primary Completion: 2024-11-15
• Study Completion: 2024-12-15
• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

All patients were

1. Both sex aged from forty to sixty years
2. Stable chronic hemodialysis patient (< 3 months)
3. Participants will be deemed medically eligible by their treating physician before participation in the present study
4. Free from any other disease could interfere with exercise

Exclusion Criteria

1. Hemodynamic instability during hemodialysis over the last month
2. Neurodegenerative diseases
3. Autoimmune diseases (i.e., lupus erythematosus)
4. Surgery within the past 3 months
5. Severe arrhythmia, angina or cerebrovascular disease
6. Unstable on dialysis
7. Any musculoskeletal problem interfere with exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
assessment of change of estimated glomerular filtration rate	at baseline and after 8 weeks	Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation (2021) as recommended by the National Kidney Foundation to assess renal function and detect deterioration.

Secondary Outcome Measures

Name	Time	Method
assessment of change of Limb Occlusion Pressure	at baseline and after 8 weeks	Limb occlusion pressure was measured using a vascular Doppler ultrasound in combination with a blood flow restriction device to determine individualized occlusion thresholds.
assessment of change of Glucose Homeostasis	at baseline and after 8 weeks	Glucose regulation was assessed through glycated hemoglobin (HbA1c) levels, reflecting average blood glucose over the previous 2-3 months
assessment of change of upper limb Muscle Strength	at baseline and after 8 weeks	Upper limb strength was measured using a handgrip dynamometer.
assessment of change of lower limb Muscle Strength	at baseline and after 8 weeks	lower limb strength was assessed using the One-Repetition Maximum (1RM) test to determine maximum voluntary strength

Trial Locations

Locations (1)

out-patient clinic, faculty of physical therapy, beni-suef University; 🇪🇬 Banī Suwayf, Egypt