Blood Flow Restriction TrainingNCT06976281
Effect of Intradialytic Blood Flow Restriction Training on Functional Capacity, Estimated Glomerular Filtration Rate and Health Related Quality of Life in Patients on Hemodialysis
A study testing conventional exercise Program and blood flow restriction training in people with Blood Flow Restriction Training and Glomerular Filtration Rate, run by Beni-Suef University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Blood Flow Restriction Training, Glomerular Filtration Rate, Quality of Life
- What is being tested?
- conventional exercise Program and blood flow restriction training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
out-patient clinic, faculty of physical therapy, beni-suef University
Banī Suwayf
About this study
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
Read the 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.
- Conditions
- Blood Flow Restriction Training, Glomerular Filtration Rate, Quality of Life, Hemodialysis
- Being tested
- conventional exercise Program, blood flow restriction training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional exercise ProgramOther
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 trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| blood flow restriction | Experimental | 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 Receives: Other: conventional exercise Program; Other: blood flow restriction training |
| conventional exercise Program | Active comparator | 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 Receives: Other: conventional exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline and after 8 weeks
Secondary outcomes (4)
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.
Measured: 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
Measured: at baseline and after 8 weeks
assessment of change of upper limb Muscle Strength
Upper limb strength was measured using a handgrip dynamometer.
Measured: 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
Measured: at baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Aug 2024
- Primary completion15 Nov 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Flow Restriction TrainingStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Sayed Abd El Aziz, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976281
- Sponsor's protocol ID
- Alaa-02012024
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intradialytic Blood Flow Restriction Training on Functional Capacity, Estimated Glomerular Filtration Rate and Health Related Quality of Life in Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT06976281
- Acronym / sponsor ID
- Alaa-02012024
- Conditions
- Blood Flow Restriction Training, Glomerular Filtration Rate, Quality of Life, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blood flow restriction | Experimental | Other: conventional exercise Program, Other: blood flow restriction trainingIncluded 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 |
| conventional exercise Program | Active comparator | Other: conventional exercise ProgramIncluded 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional exercise ProgramExercises 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, conventional exercise Program |
| blood flow restriction trainingPatients 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 | Other | blood flow restriction |
Primary outcome
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.
4 secondary outcomes
assessment of change of Limb Occlusion Pressure
Time frame: at baseline and after 8 weeks
assessment of change of Glucose Homeostasis
Time frame: at baseline and after 8 weeks
assessment of change of upper limb Muscle Strength
Time frame: at baseline and after 8 weeks
assessment of change of lower limb Muscle Strength
Time frame: at baseline and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional exercise Program and blood flow restriction training in people with Blood Flow Restriction Training and Glomerular Filtration Rate, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of change of estimated glomerular filtration rate (time frame: at baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.