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

May 9, 2025 updated by: Alaa Sayed Abd El Aziz, Beni-Suef University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at baseline and after 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
at baseline and after 8 weeks
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
at baseline and after 8 weeks
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.
at baseline and after 8 weeks
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
at baseline and after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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