NCT06976281

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 9, 2025

Last Update Submit

May 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • assessment of change of Limb Occlusion Pressure

    at baseline and after 8 weeks

  • assessment of change of Glucose Homeostasis

    at baseline and after 8 weeks

  • assessment of change of upper limb Muscle Strength

    at baseline and after 8 weeks

  • assessment of change of lower limb Muscle Strength

    at baseline and after 8 weeks

Study Arms (2)

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

Other: conventional exercise ProgramOther: 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

Other: conventional exercise Program

Interventions

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 restrictionconventional exercise Program

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

blood flow restriction

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Banī Suwayf, Egypt

Location

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 9, 2025

First Posted

May 16, 2025

Study Start

August 1, 2024

Primary Completion

November 15, 2024

Study Completion

December 15, 2024

Last Updated

May 16, 2025

Record last verified: 2025-05

Locations