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Completed

NCT Number: NCT06976281

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

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Key information

Conditions

Blood Flow Restriction Training Glomerular Filtration Rate Hemodialysis Quality of Life

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

out-patient clinic, faculty of physical therapy, beni-suef University

Banī Suwayf, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients were

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

Exclusion criteria

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

Treatment and study plan

Conventional Exercise Program

Other

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

Blood Flow Restriction training

Other

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

Primary outcomes

  1. assessment of change of estimated glomerular filtration rate

    Time frame: 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 outcomes

  1. assessment of change of Limb Occlusion Pressure

    Time frame: 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.

  2. assessment of change of Glucose Homeostasis

    Time frame: 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

  3. assessment of change of upper limb Muscle Strength

    Time frame: at baseline and after 8 weeks

    Upper limb strength was measured using a handgrip dynamometer.

  4. assessment of change of lower limb Muscle Strength

    Time frame: at baseline and after 8 weeks

    lower limb strength was assessed using the One-Repetition Maximum (1RM) test to determine maximum voluntary strength

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 16, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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