Actively Recruiting

Phase Not Applicable
Age: 20Years - 79Years
All Genders
NCT07269379

Intradialytic Exercise With Blood Flow Restriction in Hemodialysis Patients

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

108

Participants Needed

2

Research Sites

152 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

The main objective is to evaluate in hemodialysis patients the effects of two intradialytic rehabilitation programs based on physical exercise, with or without the application of blood flow restriction, on myocardial stunning and morpho-functional cardiac remodelling, compared with usual care (i.e., dialysis without exercise). In addition, the investigators will also assess the acute effects (i.e., a single session for each condition) of physical exercise, with or without blood flow restriction, on myocardial stunning at the end of dialysis. In comparison with a conventional exercise program, the combination of physical exercise with blood flow restriction, which synergistically and additively activates intramuscular signalling pathways related to both exercise and ischaemia, is hypothesised to result in: 1. A greater intradialytic cardioprotection, as demonstrated by a greater reduction in myocardial stunning at the end of dialysis (both in acute and chronic applications), with underlying mechanisms involving systemic and neuro-humoral pathways; 2. Significant improvements in morpho-functional cardiac remodelling, attenuation of arrhythmic disturbances, and enhancement of aerobic capacity, muscle strength, and muscle mass-effects not observed with exercise alone without blood flow restriction, considering the low exercise intensity used in the current rehabilitation program (chronic application only). This is a three-arm randomised clinical trial with parallel groups: standard hemodialysis (HD-CONTChro), a rehabilitation program with intradialytic exercise without vascular occlusion (HD-EXChro), and a rehabilitation program with intradialytic exercise with vascular occlusion (HD-BFREChro), with a 1:1:1 allocation ratio. To investigate the acute effects of the interventions, all patients will undergo, in a randomized order, one session of each of the three dialysis modalities-standard hemodialysis (HD-CONTacute), hemodialysis with exercise without vascular restriction (HD-EXacute), and hemodialysis with exercise with vascular restriction (HD-BFREacute)-prior to initiation of the chronic phase of the study.

CONDITIONS

Official 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.
  • No engagement in regular exercise outside of dialysis.
  • No prior exposure to intradialytic exercise within the past six months.
  • No medical contraindications to physical activity.
  • Life expectancy greater than 6 months.
  • Patients with relative good echogenicity
Not Eligible

You will not qualify if you...

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

AI-Screening

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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

CONTACT

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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