Exercise during dialysis with blood flow restriction versus regular dialysis exercise
Intradialytic Exercise With Blood Flow Restriction by Vascular Occlusion: A New Strategy for Cardioprotection in Hemodialysis Patients
This test will try whether doing exercise during hemodialysis with a blood flow restriction band protects the heart more than regular intradialytic exercise or no exercise for people on dialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 20 Years to 79 Years |
| Sex | All |
| Sponsor | University of Avignon Academic / other |
| Locations | 2 sites (Strasbourg and 1 other locations) |
| Trial ID | NCT07269379 on ClinicalTrials.gov |
What this trial studies
Adults on maintenance hemodialysis will be assigned to two intradialytic rehabilitation programs—exercise with or without blood flow restriction—or to usual care, and followed over time to compare effects on myocardial stunning and cardiac remodeling. The protocol includes both an acute component (single-session measurements of myocardial stunning at the end of dialysis) and a chronic component (repeated intradialytic sessions to evaluate longer-term morpho-functional cardiac changes). Cardiac function and myocardial stunning will be monitored using echocardiography and other standard clinical measures. The intervention aims to combine exercise and transient limb ischemia from blood flow restriction to amplify protective signaling compared with conventional exercise or no exercise.
Who should consider this trial
Good fit: Ideal candidates are adults 20–79 years old who have been on hemodialysis for more than three months, are clinically stable with no contraindications to exercise, are not regularly exercising outside dialysis, and have adequate echogenicity for cardiac imaging.
Not a fit: Patients unlikely to benefit include those with unstable coronary artery disease, advanced peripheral artery disease of the legs (stage III–IV), pregnancy or recent breastfeeding, severe contraindications to exercise, or those already engaged in intradialytic exercise.
Why it matters
Potential benefit: If successful, the approach could reduce dialysis-associated myocardial stunning and improve cardiac remodeling, potentially lowering cardiovascular complications in hemodialysis patients.
How similar studies have performed: Prior studies show intradialytic exercise can improve functional outcomes and separate research supports blood flow restriction for enhancing muscle adaptations, but combining BFR with intradialytic exercise for cardioprotection in dialysis patients is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Strasbourg and 1 other locations
- CHU Strasbourg — Strasbourg, France (Not_yet_recruiting)
- Medipole Lyon — Villeurbanne, France (Recruiting)
Study contacts
- Principal investigator: Nans Florens, PhD — CHU Strasbourg
- Study coordinator: Philippe Obert, PhD
- Email: philippe.obert@univ-avignon.fr
- Phone: 0033698050446
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.