Evaluating exercise and remote ischemic preconditioning during hemodialysis for heart protection
Intradialytic Exercise and Remote Ischaemic Preconditioning: a Cardioprotective Role ?
This study is testing if adding exercise and a special technique during hemodialysis can help protect the hearts of adults with kidney issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 20 Years to 79 Years |
| Sex | All |
| Sponsor | University of Avignon Academic / other |
| Locations | 3 sites (Montpellier and 2 other locations) |
| Trial ID | NCT06856512 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the cardioprotective effects of intermittent exercise and remote ischemic preconditioning (rIPC) during hemodialysis in adult patients. Participants will undergo three randomized hemodialysis sessions, comparing standard treatment with sessions that include moderate-intensity exercise and rIPC. The study will evaluate the impact of these interventions on myocardial function, arrhythmias, systemic inflammation, and overall dialysis efficiency. Cardiac function and biomarkers will be monitored before, during, and after the hemodialysis sessions to determine the effectiveness of the interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 79 years who have been on hemodialysis for more than three months and do not engage in regular exercise.
Not a fit: Patients with unstable coronary artery disease or those with severe peripheral artery disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart health and reduced complications for patients undergoing hemodialysis.
How similar studies have performed: While the specific combination of interventions is novel, similar studies have shown promising results in improving cardiac outcomes in hemodialysis patients.
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.
Where this trial is running
Montpellier and 2 other locations
- Aider Sante — Montpellier, France (Active_not_recruiting)
- Aider Sante — Nimes, France (Recruiting)
- CHU Strasbourg — Strasbourg, France (Enrolling_by_invitation)
Study contacts
- Principal investigator: Laure Patrier, MD, PhD — AIDER Santé - Fondation Charles Mion
- 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.