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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Hemodialysis; Glomerular Filtration Rate; Blood Flow Restriction Training
• Intervention / Treatment: Other: conventional exercise Program; Other: blood flow restriction training

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt
    • out-patient clinic, faculty of physical therapy, beni-suef University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: blood flow restriction; Included 15 chronic kidney disease patients on hemodialysis received conventional exercise program included isometric, aerobic, and resisted exercise individualized for every patient with blood flow restriction by 50% of limb occlusion Pressure. training was conducted for 2 time/weak for 2 consecutive month	Other: conventional exercise Program; Exercises include shoulder flexion, shoulder abduction, leg extension, and hand grip. Start with 1-3 sets of 12 reps at 30% of 1-repetition maximum, increasing by 10% according to patient endurance. Cycling is a 30-minute chair or bedside cycle ergometer exercise 2 time/weak for 2 consecutive months; Other: blood flow restriction training; Patients received the same conventional exercise program, which included isometric, aerobic, and resisted exercise individualized for every patient with blood flow restriction by 50% of limb occlusion pressure. Training will be conducted for 2 time/weak for 2 consecutive month
Active Comparator: conventional exercise Program; Included 15 chronic kidney disease patients on hemodialysis received conventional exercise program only included isometric, aerobic, and resisted exercise individualized for every patient. training was conducted for 2 time/weak for 2 consecutive month	Other: conventional exercise Program; Exercises include shoulder flexion, shoulder abduction, leg extension, and hand grip. Start with 1-3 sets of 12 reps at 30% of 1-repetition maximum, increasing by 10% according to patient endurance. Cycling is a 30-minute chair or bedside cycle ergometer exercise 2 time/weak for 2 consecutive months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of change of estimated glomerular filtration rate	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.	at baseline and after 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): November 15, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: May 9, 2025
• First Submitted That Met QC Criteria: May 9, 2025
• First Posted (Actual): May 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Alaa-02012024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No