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Intradialytic Exercise With Blood Flow Restriction in Hemodialysis Patients

RecruitingNAAges 20 Years - 79 YearsAllUniversity of Avignon
NCT07269379 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 reducti

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Patient is participating in another Category I interventional study, or has participated in another interventional study within the past 3 months * The patient is in an exclusion period determined by a previous study * The patient is under legal protection or under guardianship or curatorship It turns out to be impossible to give the patient informed information, or the patient refuses to sign the consent * Pregnant, parturient or breastfeeding patient * Patients with unstable coronary artery disease. * Patients with peripheral artery disease (stage III or IV) in the lower limbs. * Patients with limb amputation. * Patients with musculoskeletal disorders impairing exercise. * Presence of a pacemaker, cardiac stimulation device, or implantable cardioverter defibrillator (ICD). * History of heart transplant. * Patients with uncontrolled hypertension. * Refractory anemia. * Patients stratified as high risk for deep venous thrombosis
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What it tests

  • Chronic phase - HDEX/HDBFRE
  • Acute phase - HDEX/HDBFRE
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Where

2 sites
CHU Strasbourg
Strasbourg, France
Medipole Lyon
Villeurbanne, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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