Clinical trial NCT06856512: Intradialytic Exercise and Remote Ischaemic Preconditioning: a Cardioprotective Role ?
Official title: Intradialytic Exercise and Remote Ischaemic Preconditioning: a Cardioprotective Role ?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodialysis
Keywords: Hemodialysis
myocardial function
exercise
remote ischemic preconditioning
myocardial stunning
cardioprotection
Lead sponsor: University of Avignon
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients are randomly assigned to standard dialysis, dialysis with intermittent intradialytic exercise and dialysis with intermittent remote ischaemic preconditioning.
Primary purpose: OTHER

Brief summary: The aim of this clinical trial is to evaluate whether intermittent exercise and remote ischaemic preconditioning (rIPC) during haemodialysis (HD) can provide cardioprotection in adult patients (aged 20-79 years) undergoing HD for at least 3 months. The main questions to be answered are

Does intermittent exercise or rIPC reduce myocardial stunning during HD? Do these interventions have a beneficial effect on haemorheology, arrhythmias, systemic inflammation and HD efficiency? The investigators will compare three HD sessions: no intervention (HD-CONT), with moderate-intensity intermittent exercise (HD-EX), and with rIPC using cuff inflation (HD-rIPC) to see if HD6EX and HD-rIPC approaches offer enhanced cardioprotection.

Participants will:

Undergo three randomised HD sessions. Participate in 5 blocks of moderate-intensity exercise or rIPC during the HD sessions.

Have cardiac function and biomarkers assessed before, during and after HD.


Eligibility 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.

Primary outcomes:
measure: Change in regional myocardial stunning.
timeFrame: From enrollment to the end of treatment at 7 weeks
Secondary outcomes:
measure: Hemorheology - blood viscosity
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Hemorheology - erythrocyte deformability
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Hemorheology - erythrocyte aggregation
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - fibrinogen
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - miRNA
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Intraventricular pressure gradient
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Hemodynamic parameters - cardiac output
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Hemodynamic parameters - blood pressure
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Intraventricular flow
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Sublingual microvasculature - proportion of perfused vessels
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Sublingual microvasculature - functional capillary density
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Sublingual microvasculature - De Baker's score
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Sublingual microvasculature - per-capillary microcirculatory flow index
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Sublingual microvasculature - red blood cell mean velocity
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Sublingual microvasculature - total vessel density
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: standard echocardiography - LA morphology and function
timeFrame: From enrollment
measure: standard echocardiography - LV volumes
timeFrame: From enrollment
measure: standard echocardiography - LV global diastolic function - E wave
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: standard echocardiography - LV global diastolic function - tricuspid regurgitation
timeFrame: From enrollment
measure: standard echocardiography - RV systolic function - TAPSE
timeFrame: From enrollment
measure: standard echocardiography - RV morphology - areas
timeFrame: From enrollment
measure: standard echocardiography - RV global diastolic function - Et wave
timeFrame: From enrollment
measure: Biological data - uraemic toxins - beta2-microglobulin
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - uraemic toxins - Indoxyl sulfate
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - uraemic toxins - p-Cresyl sulfate
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - uraemic toxins - myoglobin
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - uraemic toxins - free light chains
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - cardiac biomarkers - NT-pro-BNP
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - cardiac biomarkers - BNP level
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - cardiac biomarkers - cardiac troponin T
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - cardiac biomarkers - sST2
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: biological data - characterization of patients - sodium
timeFrame: From enrollment
measure: biological data - characterization of patients - potassium
timeFrame: From enrollment
measure: biological data - characterization of patients - calcium
timeFrame: From enrollment
measure: biological data - characterization of patients - phosphate
timeFrame: From enrollment
measure: biological data - characterization of patients - vitamin D
timeFrame: From enrollment
measure: biological data - characterization of patients - parathyroid hormone
timeFrame: From enrollment
measure: biological data - characterization of patients - creatinine
timeFrame: From enrollment
measure: biological data - characterization of patients - creatinine clearance
timeFrame: From enrollment
measure: biological data - characterization of patients - urea
timeFrame: From enrollment
measure: biological data - characterization of patients - Kt/V
timeFrame: From enrollment
measure: biological data - characterization of patients - nPCR
timeFrame: From enrollment
measure: biological data - characterization of patients - albumin
timeFrame: From enrollment
measure: biological data - characterization of patients - CRP
timeFrame: From enrollment
measure: biological data - hematology - complete blood count
timeFrame: From enrollment
measure: biological data - hematology - ferritin
timeFrame: From enrollment
measure: biological data - hematology - transferrin saturation
timeFrame: From enrollment
measure: Hematology - hematocrit
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Hematology - hemoglobin
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: biological data - lipidic profile - LDL cholesterol
timeFrame: From enrollment
measure: biological data - lipidic profile - HDL cholesterol
timeFrame: From enrollment
measure: biological data - lipidic profile - triglycerides
timeFrame: From enrollment
measure: Biological data - inflamation - ultra-sensitive c-reactive protein
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - inflamation - interleukin-6
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - inflamation - interleukin-10
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - inflamation - tumor necrosis factor-α
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - endothelial cell activation - intercellular adhesion molecule-1
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - endothelial cell activation - vascular cell adhesion molecule-1
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - endothelial cell activation - endothelin
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Biological data - endothelial cell activation - proendothelin
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: biological data - insulin resistance - glucose
timeFrame: From enrollment
measure: biological data - insulin resistance - glycated hemoglobin
timeFrame: From enrollment
measure: biological data - insulin resistance - insulin
timeFrame: From enrollment
measure: Hemodynamic parameters - heart rate
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Hemodynamic parameters - stroke volume
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Strains - LV
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Strains - RV
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Strains - LA
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: standard echocardiography - LV morphology - diameter
timeFrame: From enrollment
measure: standard echocardiography - LV morphology - wal thicknessess
timeFrame: From enrollment
measure: standard echocardiography - RV morphology - diameters
timeFrame: From enrollment
measure: standard echocardiography - LV global systolic function
timeFrame: From enrollment
measure: standard echocardiography - LV morphology - mass
timeFrame: From enrollment
measure: Myocardial work - global myocardial work
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Myocardial work - global constructive work
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Myocardial work - global wasted work
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: Myocardial work - global work efficiency
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: standard echocardiography - LV global diastolic function - A wave
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: standard echocardiography - RV systolic function
timeFrame: From enrollment
measure: standard echocardiography - RV global diastolic function
timeFrame: From enrollment
measure: standard echocardiography - tissue Doppler imaging - LV e'
timeFrame: From enrollment
measure: standard echocardiography - tissue Doppler imaging - LV a'
timeFrame: From enrollment
measure: standard echocardiography - tissue Doppler imaging - LV s'
timeFrame: From enrollment
measure: standard echocardiography - tissue Doppler imaging - RV e'
timeFrame: From enrollment
measure: standard echocardiography - tissue Doppler imaging- RV a'
timeFrame: From enrollment
measure: standard echocardiography - tissue Doppler imaging - RV s'
timeFrame: From enrollment
measure: standard echocardiography - RV morphology and function - diameters
timeFrame: From enrollment
measure: standard echocardiography - RV global diastolic function - Et/At ratio
timeFrame: From enrollment
measure: standard echocardiography - LV global diastolic function - E/A
timeFrame: From enrollment to the end of treatment at 7 weeks
measure: standard echocardiography - diastolic function - LV E/e'
timeFrame: From enrollment
measure: standard echocardiography - diastolic function - RV Et/e'
timeFrame: From enrollment
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Aider Sante
city: Nimes
country: France
facility: Aider Sante
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
affiliation: AIDER Santé - Fondation Charles Mion
name: Laure Patrier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: