New treatment option for Dialysis Patients
Official title Intradialytic Exercise With Blood Flow Restriction in Hemodialysis Patients
ClinicalTrials.gov ID: NCT07269379
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 79
You may be able to join if
- 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.
You likely can't join if
- Patient is participating in another Category I treatment study, or has participated in another treatment 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...
- Pregnant, parturient or breastfeeding patient
- Patients with unstable coronary artery disease.
- Patients with peripheral artery disease (stage III or IV) in the lower limbs.
See the full eligibility 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
- Patient is participating in another Category I treatment study, or has participated in another treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, France
- Villeurbanne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, France; Villeurbanne, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.