Actively Recruiting

Phase Not Applicable
Age: 20Years - 79Years
All Genders
ID07269379

Intradialytic Exercise With Blood Flow Restriction by Vascular Occlusion: A New Strategy for Cardioprotection in Hemodialysis Patients

Led by University of Avignon · Updated on 2025-12-08

108

Participants Needed

2

Research Sites

21 weeks

Total Duration

On this page

Sponsors

U

University of Avignon

Lead Sponsor

M

Médipôle Lyon-Villeurbanne

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of two different intradialytic rehabilitation programs involving physical exercise, with or without blood flow restriction, on heart function and structure in patients undergoing hemodialysis. The study aims to compare these exercise programs to usual care without exercise, focusing on reducing myocardial stunning and improving cardiac remodeling. It also investigates the immediate effects of exercise sessions with and without blood flow restriction during dialysis. The study includes three groups: one receiving standard hemodialysis with no exercise, one participating in a 12-week intradialytic exercise program without vascular occlusion, and one participating in a 12-week program with vascular occlusion applying blood flow restriction. Exercise sessions involve 30 minutes of moderate-intensity cycling three times a week, starting 30 minutes after dialysis begins. The acute effects are tested by having patients undergo one session of each dialysis modality in randomized order before starting the chronic phase. Participants will be monitored from enrollment through 19 weeks, undergoing assessments including heart ultrasound measurements, blood pressure, blood tests for various markers related to heart function, inflammation, and muscle health. Researchers will evaluate changes in cardiac motion abnormalities, heart strain, blood chemistry, and muscle strength. Safety and heart rhythm will also be followed, with the study running until October 2028.

CONDITIONS

Brief Title

Intradialytic Exercise With Blood Flow Restriction in Hemodialysis Patients

Who Can Participate

Age: 20Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 20 and 79 years
  • Patients on hemodialysis for more than 3 months
  • Not regularly exercising outside of dialysis
  • No intradialytic exercise in the past six months
  • No medical contraindications to physical activity
  • Life expectancy greater than 6 months
  • Patients with relatively good echogenicity
Not Eligible

You will not qualify if you...

  • Participation in another Category I interventional study currently or within the past 3 months
  • In an exclusion period from a previous study
  • Under legal protection, guardianship, or curatorship, or unable/unwilling to give informed consent
  • Pregnant, parturient, or breastfeeding
  • Unstable coronary artery disease
  • Peripheral artery disease stage III or IV in lower limbs
  • Limb amputation
  • Musculoskeletal disorders impairing exercise
  • Presence of pacemaker, cardiac stimulation device, or implantable cardioverter defibrillator
  • History of heart transplant
  • Uncontrolled hypertension
  • Refractory anemia
  • High risk for deep venous thrombosis

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants undergo intradialytic cycling exercise during hemodialysis sessions, either with or without blood flow restriction, to evaluate cardioprotection effects.

3 sessions per week during hemodialysis

Follow-up

Duration - Up to 7 weeks after treatment

Participants are monitored until the end of the program to assess changes in cardiac function and various blood parameters.

Visits aligned with routine hemodialysis schedule

Trial Site Locations

Total: 2 locations

1

CHU Strasbourg

Strasbourg, France

Not Yet Recruiting

2

Medipole Lyon

Villeurbanne, France, 69100

Actively Recruiting

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Research Team

P

Philippe Obert, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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