HemodialysisEXPI-DIALNCT06856512
Intradialytic Exercise and Remote Ischaemic Preconditioning: a Cardioprotective Role ?
A study testing Remote ischaemic preconditioning, Exercise and standard dialysis in people with Hemodialysis, run by University of Avignon at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Remote ischaemic preconditioning, Exercise and standard dialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesFrance
- Study dates
- 17 Feb 2025to 26 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Aider Sante
Montpellier
Aider Sante
Nîmes
CHU Strasbourg
Strasbourg
About this study
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.
Read more
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.
- Conditions
- Hemodialysis
- Being tested
- Remote ischaemic preconditioning, Exercise, standard dialysis
- Keywords
- Hemodialysis, myocardial function, exercise, remote ischemic preconditioning, myocardial stunning, cardioprotection
- Medical subject headings
- Motor Activity, Myocardial Stunning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischaemic preconditioningOther
The dialysis protocol integrates a sequence of five ischaemia/reperfusion blocks applied to the upper limb. Each block consists of a 5-minute period of cuff inflation at a supra-systolic pressure individualized to each patient-20 mmHg above the limb occlusion pressure-followed by a 25-minute period of cuff deflation. This intervention begins 30 minutes after the start of dialysis and is referred to as hemodialysis remote ischaemic preconditioning (HD-rIPC).
ExerciseOther
The exercise protocol consists of five sequential bouts of physical activity, initiated 30 minutes after the start of dialysis. Each bout comprises a 5-minute cycling exercise at moderate intensity, corresponding to a Borg Scale rating of 12-14, followed by a 25-minute passive recovery phase. This structured intervention is referred to as hemodialysis exercise (HD-EX).
standard dialysisOther
The hemodialysis control condition (HD-CONT) consists of standard hemodialysis treatment without the integration of any additional interventions, such as exercise or ischaemia/reperfusion protocols.
| Study group | Role | What they receive |
|---|---|---|
| Patients issued from dialysis units (clinic) | Experimental | Randomised, controlled, crossover, bicentric, single-blind, prospective, open-label, superiority clinical trial comparing 3 dialysis modalities:
Procedure A: Standard dialysis
Procedure B: Dialysis with intradialytic intermittent physical exercise
Procedure C: Dialysis with intradialytic ischaemia/reperfusion sequence of the upper limb
Each subject will realize the 3 sessions in a random order. Receives: Other: Remote ischaemic preconditioning; Other: Exercise; Other: standard dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in regional myocardial stunning.
The investigators will use echocardiography to assess the number of left ventricular myocardial segments (using a 18-segment model), that demonstrate a reduction in longitudinal deformation greater than 20% at peak stress during hemodialysis, relative to baseline measurements obtained at the start of the dialysis session. Their aim is to compare changes in regional wall motion abnormalities across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Secondary outcomes (91)
Hemorheology - blood viscosity
The investigators will assess variations in whole blood viscosity, measured using a cone-plate viscometer, from the beginning to the peak stress of dialysis. Their aim is to compare these changes in whole blood viscosity across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset of dialysis and just before its end. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Hemorheology - erythrocyte deformability
The investigators will assess variations in erythrocyte deformability, measured using an ektacytometer, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset of dialysis and just before its end. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Hemorheology - erythrocyte aggregation
The investigators will assess variations in erythrocyte aggregation, measured using an ektacytometer, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset of dialysis and just before its end. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - fibrinogen
The investigators will assess variations in fibrinogen, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset of dialysis and just before its end. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - miRNA
The investigators will assess variations in levels of circulating mi-RNAs, quantified by reverse transcription-quantitative polymerase chain reaction (RT-qPCR), from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Intraventricular pressure gradient
The investigators will assess variations in the left intraventricular pressure gradient, measured by postprocessing color Doppler M-mode echocardiographic images, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Hemodynamic parameters - cardiac output
The investigators will measure cardiac output every 30minutes from the beginning to the end of dialysis during the 3 conditions. Their aim is to compare the changes during HD across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). For HD-EX and HD-RIPC, the investigators will add a measure immediately after the interventions (exercise or vascular occlusion) to control for the effect of the intervention. Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Hemodynamic parameters - blood pressure
The investigators will measure blood pressure every 30minutes from the beginning to the end of dialysis during the 3 conditions. Their aim is to compare the changes during HD across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). For HD-EX and HD-RIPC, the investigators will add a measure immediately after the interventions (exercise or vascular occlusion) to control for the effect of the intervention. Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Intraventricular flow
The investigators will assess variations in the velocity vector fields of blood flow in the LV, calculated by postprocessing color Doppler echocardiographic images, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Sublingual microvasculature - proportion of perfused vessels
The investigators will assess the variation in the proportion of perfused vessels, measured using a videomicroscope, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Sublingual microvasculature - functional capillary density
The investigators will assess the variation in functional capillary density, measured using a videomicroscope, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Sublingual microvasculature - De Baker's score
The investigators will assess the variation in De Baker's score, measured using a videomicroscope, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Sublingual microvasculature - per-capillary microcirculatory flow index
The investigators will assess the variation in per-capillary microcirculatory flow index, measured using a videomicroscope, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Sublingual microvasculature - red blood cell mean velocity
The investigators will assess the variation in red blood cell mean velocity, measured using a videomicroscope, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Sublingual microvasculature - total vessel density
The investigators will assess the variation in total vessel density, measured using a videomicroscope, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
standard echocardiography - LA morphology and function
The investigators will evaluate the left atrial (LA) volumes during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to characterize the LA morphology and function of the patients. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - LV volumes
The investigators will evaluate the left ventricular (LV) volumes using echocardiography during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - LV global diastolic function - E wave
The investigators will evaluate the variation in E wave by pulsed Doppler ehocardiography from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
standard echocardiography - LV global diastolic function - tricuspid regurgitation
The investigators will evaluate the tricuspid regurgitation by continuous-wave Doppler ehocardiography during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. It will be used to characterize left ventricular global diastolic function. Measurements will be conducted 30 minutes before the onset of dialysis
Measured: From enrollment
standard echocardiography - RV systolic function - TAPSE
The investigators will evaluate the Tricuspid Annular Plane Systolic Excursion using echocardiography during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. It will be used to characterize right ventricular global systolic function. Measurements will be conducted 30 minutes before the onset of dialysis
Measured: From enrollment
standard echocardiography - RV morphology - areas
The investigators will evaluate the right ventricular (RV) area at end-systole and end-diastole during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - RV global diastolic function - Et wave
The investigators will evaluate the Et wave by pulsed Doppler ehocardiography during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. It will be used to characterize right ventricular global diastolic function. Measurements will be conducted 30 minutes before the onset of dialysis
Measured: From enrollment
Biological data - uraemic toxins - beta2-microglobulin
The investigators will assess variations in beta2-microglobulin level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - uraemic toxins - Indoxyl sulfate
The investigators will assess variations in indoxyl sulfate level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - uraemic toxins - p-Cresyl sulfate
The investigators will assess variations in p-Cresyl sulfate level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - uraemic toxins - myoglobin
The investigators will assess variations in myoglobin level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - uraemic toxins - free light chains
The investigators will assess variations in free light chains, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - cardiac biomarkers - NT-pro-BNP
The investigators will assess variations in NT-pro-BNP level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - cardiac biomarkers - BNP level
The investigators will assess variations in BNP level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - cardiac biomarkers - cardiac troponin T
The investigators will assess variations in cardiac troponin T level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - cardiac biomarkers - sST2
The investigators will assess variations in levels of soluble ST2, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
biological data - characterization of patients - sodium
The investigators will evaluate the blood level of sodium during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the progression of the disease in the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - characterization of patients - potassium
The investigators will evaluate the serum level of potassium during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the progression of the disease in the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - characterization of patients - calcium
The investigators will evaluate the serum level of calcium during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the progression of the disease in the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - characterization of patients - phosphate
The investigators will evaluate the serum level of phosphate during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the progression of the disease in the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - characterization of patients - vitamin D
The investigators will evaluate the serum level of vitamin D during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the progression of the disease in the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - characterization of patients - parathyroid hormone
The investigators will evaluate the serum level of parathyroid hormone during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the progression of the disease in the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - characterization of patients - creatinine
The investigators will evaluate the serum level of creatinine during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the progression of the disease in the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - characterization of patients - creatinine clearance
The investigators will evaluate the creatinine clearance during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the progression of the disease in the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - characterization of patients - urea
The investigators will evaluate the blood level of urea during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the progression of the disease in the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - characterization of patients - Kt/V
The investigators will evaluate the Kt/V urea during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the progression of the disease in the patients.
Measured: From enrollment
biological data - characterization of patients - nPCR
The investigators will evaluate the normalized proteïn catabolic rate during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the progression of the disease in the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - characterization of patients - albumin
The investigators will evaluate the serum level of albumin during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the progression of the disease in the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - characterization of patients - CRP
The investigators will evaluate the serum level of c-reactiv protein during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the progression of the disease in the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - hematology - complete blood count
The investigators will evaluate the complete blood count during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the blood of patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - hematology - ferritin
The investigators will evaluate the serum ferritin level during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the blood of patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - hematology - transferrin saturation
The investigators will evaluate the transferrine saturation during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the blood of patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
Hematology - hematocrit
The investigators will assess variations in hematocrit, measured using an hemoglobinometer, from the beginning to the peak stress of dialysis. Their aim is to compare these changes in whole blood viscosity across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Hematology - hemoglobin
The investigators will assess variations in hemoglobin level, measured using an hemoglobinometer, from the beginning to the peak stress of dialysis. Their aim is to compare these changes in whole blood viscosity across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
biological data - lipidic profile - LDL cholesterol
The investigators will evaluate the LDL cholesterol during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the lipidic profile. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - lipidic profile - HDL cholesterol
The investigators will evaluate the HDL cholesterol during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the lipidic profile of patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - lipidic profile - triglycerides
The investigators will evaluate the triglycerides level during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrolment. They will be used to characterize the lipidic profile of patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
Biological data - inflamation - ultra-sensitive c-reactive protein
The investigators will assess variations in ultra-sensitive c-reactive protein level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset of the dialysis and at its end. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - inflamation - interleukin-6
The investigators will assess variations in interleukin-6 level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset of the dialysis and at its end. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - inflamation - interleukin-10
The investigators will assess variations in interleukin-10 level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset of the dialysis and at its end. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - inflamation - tumor necrosis factor-α
The investigators will assess variations in tumor necrosis factor-α level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset of the dialysis and at its end. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - endothelial cell activation - intercellular adhesion molecule-1
The investigators will assess variations in intercellular adhesion molecule-1 level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset of the dialysis and at its end. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - endothelial cell activation - vascular cell adhesion molecule-1
The investigators will assess variations in vascular cell adhesion molecule-1 level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset of the dialysis and at its end. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - endothelial cell activation - endothelin
The investigators will assess variations in endothelin level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset of the dialysis and at its end. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Biological data - endothelial cell activation - proendothelin
The investigators will assess variations in proendothelin level, measured by analysing blood sample, from the beginning to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset of the dialysis and at its end. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
biological data - insulin resistance - glucose
The investigators will evaluate the glucose level during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to quantify the insulin resistance of patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - insulin resistance - glycated hemoglobin
The investigators will evaluate the glycated hemoglobin level during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to quantify the insulin resistance of patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
biological data - insulin resistance - insulin
The investigators will evaluate the insulin level during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to quantify the insulin resistance of patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.
Measured: From enrollment
Hemodynamic parameters - heart rate
The investigators will measure heart rate every 30minutes from the beginning to the end of dialysis during the 3 conditions. Their aim is to compare the changes during HD across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). For HD-EX and HD-RIPC, the investigators will add a measure immediately after the interventions (exercise or vascular occlusion) to control for the effect of the intervention. Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Hemodynamic parameters - stroke volume
The investigators will measure stroke volume every 30minutes from the beginning to the end of dialysis during the 3 conditions. Their aim is to compare the changes during HD across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). For HD-EX and HD-RIPC, the investigators will add a measure immediately after the interventions (exercise or vascular occlusion) to control for the effect of the intervention. Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Strains - LV
The investigators will assess variations in left longitudinal strains, using speckle tracking echocardiography, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Strains (in %) measure the amount of myocardial longitudinal shortening of the cavity, are relatively load-independent, and can detect subclinical myocardial dysfunction, even when it is not apparent by conventional echocardiography.
Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Strains - RV
The investigators will assess variations in right ventricular longitudinal strains, using speckle tracking echocardiography, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Strains (in %) measure the amount of myocardial longitudinal shortening of the cavity, are relatively load-independent, and can detect subclinical myocardial dysfunction, even when it is not apparent by conventional echocardiography.
Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Strains - LA
The investigators will assess variations in left atrial longitudinal strains, using speckle tracking echocardiography, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Strains (in %) measure the amount of myocardial longitudinal shortening of the cavity, are relatively load-independent, and can detect subclinical myocardial dysfunction, even when it is not apparent by conventional echocardiography.
Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
standard echocardiography - LV morphology - diameter
The investigators will evaluate the left ventricular (LV) diameter at both end-diastole and end-systole during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to characterize the LV morphology of the patients. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - LV morphology - wal thicknessess
The investigators will evaluate the left ventricular (LV) wall thicknesses at both end-diastole and end-systole during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to characterize the LV morphology of the patients. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - RV morphology - diameters
The investigators will evaluate the right ventricular (RV) diameters at end-systole and end-diastole during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to characterize the RV morphology of the patients. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - LV global systolic function
The investigators will evaluate the left ventricular (LV) ejection fraction using echocardiography during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to evaluate the LV global systolic function. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - LV morphology - mass
The investigators will evaluate the left ventricular (LV) mass during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to characterize the LV morphology of the patients. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
Myocardial work - global myocardial work
The investigators will assess variations in global myocardial work, using speckle tracking echocardiography and blood pressure, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). It provides a more precise assessment of cardiac performance than strains by considering the left ventricular loading condition. Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Myocardial work - global constructive work
The investigators will assess variations in global constructive work, using speckle tracking echocardiography and blood pressure, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). It provides a more precise assessment of cardiac performance than strains by considering the left ventricular loading condition. Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Myocardial work - global wasted work
The investigators will assess variations in global wasted work, using speckle tracking echocardiography and blood pressure, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). It provides a more precise assessment of cardiac performance than strains by considering the left ventricular loading condition. Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
Myocardial work - global work efficiency
The investigators will assess variations in global work efficiency, using speckle tracking echocardiography and blood pressure, from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). It provides a more precise assessment of cardiac performance than strains by considering the left ventricular loading condition. Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
standard echocardiography - LV global diastolic function - A wave
The investigators will evaluate the variation in A wave measured by pulsed Doppler ehocardiography from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
standard echocardiography - RV systolic function
The investigators will calculate the right ventricular fractional area change using echocardiography during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. It will be used to characterize right ventricular global systolic function. Measurements will be conducted 30 minutes before the onset of dialysis
Measured: From enrollment
standard echocardiography - RV global diastolic function
The investigators will evaluate the At wave by pulsed Doppler ehocardiography during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. It will be used to characterize right ventricular global diastolic function. Measurements will be conducted 30 minutes before the onset of dialysis
Measured: From enrollment
standard echocardiography - tissue Doppler imaging - LV e'
The investigators will evaluate the left ventricular (LV) e' wave by tissue Doppler imaging during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to characterize the LV regional function of the patients. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - tissue Doppler imaging - LV a'
The investigators will evaluate the left ventricular (LV) a' wave by tissue Doppler imaging during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to characterize the LV function of the patients. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - tissue Doppler imaging - LV s'
The investigators will evaluate the left ventricular (LV) s' waves by tissue Doppler imaging during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to characterize the LV regional function of the patients. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - tissue Doppler imaging - RV e'
The investigators will evaluate the right ventricular (RV) e' wave by tissue Doppler imaging during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to characterize the RV regional function of the patients. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - tissue Doppler imaging- RV a'
The investigators will evaluate the right ventricular (RV) a' wave by tissue Doppler imaging during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to characterize the RV regional function of the patients. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - tissue Doppler imaging - RV s'
The investigators will evaluate the right ventricular (RV) s' wave by tissue Doppler imaging during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to characterize the RV regional function of the patients. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - RV morphology and function - diameters
The investigators will evaluate the right ventricular (RV) outflow tract diameters during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to characterize the RV morphology and function of the patients. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - RV global diastolic function - Et/At ratio
The investigators will evaluate the Et/At ratio by pulsed Doppler ehocardiography during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. It will be used to characterize right ventricular global diastolic function. Measurements will be conducted 30 minutes before the onset of dialysis
Measured: From enrollment
standard echocardiography - LV global diastolic function - E/A
The investigators will evaluate the E/A ratio by pulsed Doppler ehocardiography from before to the peak stress of dialysis. Their aim is to compare these changes across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
Measured: From enrollment to the end of treatment at 7 weeks
standard echocardiography - diastolic function - LV E/e'
The investigators will evaluate the left ventricular (LV) E/e' ratio during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to characterize the LV filling pressure. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
standard echocardiography - diastolic function - RV Et/e'
The investigators will evaluate the right ventricular (RV) Et/e' ratio during the first dialysis session (HD-CONT, HD-EX, or HD-rIPC, depending on the randomized order of the three sessions), after enrollment. They will be used to characterize the RV filling pressure. Measurements will be conducted 30 minutes before the onset of dialysis.
Measured: From enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start17 Feb 2025
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients are randomly assigned to standard dialysis, dialysis with intermittent intradialytic exercise and dialysis with intermittent remote ischaemic preconditioning.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Avignon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure Patrier, MD, PhD, Principal investigator, AIDER Santé - Fondation Charles Mion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856512
- Sponsor's protocol ID
- AU-092024-CM
- Other IDs
- LAPEC/2024/DIAL
- Acronym
- EXPI-DIAL
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradialytic Exercise and Remote Ischaemic Preconditioning: a Cardioprotective Role ?
- ClinicalTrials.gov ID
- NCT06856512
- Acronym / sponsor ID
- EXPI-DIAL / AU-092024-CM
- Conditions
- Hemodialysis
- Keywords
- Hemodialysis, myocardial function, exercise, remote ischemic preconditioning, myocardial stunning, cardioprotection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of AvignonUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients are randomly assigned to standard dialysis, dialysis with intermittent intradialytic exercise and dialysis with intermittent remote ischaemic preconditioning.
| Arm | Type | Receives |
|---|---|---|
| Patients issued from dialysis units (clinic) | Experimental | Other: Remote ischaemic preconditioning, Other: Exercise, Other: standard dialysisRandomised, controlled, crossover, bicentric, single-blind, prospective, open-label, superiority clinical trial comparing 3 dialysis modalities: Procedure A: Standard dialysis Procedure B: Dialysis with intradialytic intermittent physical exercise Procedure C: Dialysis with intradialytic ischaemia/reperfusion sequence of the upper limb Each subject will realize the 3 sessions in a random order. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischaemic preconditioningThe dialysis protocol integrates a sequence of five ischaemia/reperfusion blocks applied to the upper limb. Each block consists of a 5-minute period of cuff inflation at a supra-systolic pressure individualized to each patient-20 mmHg above the limb occlusion pressure-followed by a 25-minute period of cuff deflation. This intervention begins 30 minutes after the start of dialysis and is referred to as hemodialysis remote ischaemic preconditioning (HD-rIPC). | Other | Patients issued from dialysis units (clinic) |
| ExerciseThe exercise protocol consists of five sequential bouts of physical activity, initiated 30 minutes after the start of dialysis. Each bout comprises a 5-minute cycling exercise at moderate intensity, corresponding to a Borg Scale rating of 12-14, followed by a 25-minute passive recovery phase. This structured intervention is referred to as hemodialysis exercise (HD-EX). | Other | Patients issued from dialysis units (clinic) |
| standard dialysisThe hemodialysis control condition (HD-CONT) consists of standard hemodialysis treatment without the integration of any additional interventions, such as exercise or ischaemia/reperfusion protocols. | Other | Patients issued from dialysis units (clinic) |
Primary outcome
Change in regional myocardial stunning.
Time frame: From enrollment to the end of treatment at 7 weeks
The investigators will use echocardiography to assess the number of left ventricular myocardial segments (using a 18-segment model), that demonstrate a reduction in longitudinal deformation greater than 20% at peak stress during hemodialysis, relative to baseline measurements obtained at the start of the dialysis session. Their aim is to compare changes in regional wall motion abnormalities across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
91 secondary outcomes
Hemorheology - blood viscosity
Time frame: From enrollment to the end of treatment at 7 weeks
Hemorheology - erythrocyte deformability
Time frame: From enrollment to the end of treatment at 7 weeks
Hemorheology - erythrocyte aggregation
Time frame: From enrollment to the end of treatment at 7 weeks
Biological data - fibrinogen
Time frame: From enrollment to the end of treatment at 7 weeks
Biological data - miRNA
Time frame: From enrollment to the end of treatment at 7 weeks
Intraventricular pressure gradient
Time frame: From enrollment to the end of treatment at 7 weeks
Hemodynamic parameters - cardiac output
Time frame: From enrollment to the end of treatment at 7 weeks
Hemodynamic parameters - blood pressure
Time frame: From enrollment to the end of treatment at 7 weeks
Intraventricular flow
Time frame: From enrollment to the end of treatment at 7 weeks
Sublingual microvasculature - proportion of perfused vessels
Time frame: From enrollment to the end of treatment at 7 weeks
Sublingual microvasculature - functional capillary density
Time frame: From enrollment to the end of treatment at 7 weeks
Sublingual microvasculature - De Baker's score
Time frame: From enrollment to the end of treatment at 7 weeks
Sublingual microvasculature - per-capillary microcirculatory flow index
Time frame: From enrollment to the end of treatment at 7 weeks
Sublingual microvasculature - red blood cell mean velocity
Time frame: From enrollment to the end of treatment at 7 weeks
Sublingual microvasculature - total vessel density
Time frame: From enrollment to the end of treatment at 7 weeks
standard echocardiography - LA morphology and function
Time frame: From enrollment
standard echocardiography - LV volumes
Time frame: From enrollment
standard echocardiography - LV global diastolic function - E wave
Time frame: From enrollment to the end of treatment at 7 weeks
standard echocardiography - LV global diastolic function - tricuspid regurgitation
Time frame: From enrollment
standard echocardiography - RV systolic function - TAPSE
Time frame: From enrollment
standard echocardiography - RV morphology - areas
Time frame: From enrollment
standard echocardiography - RV global diastolic function - Et wave
Time frame: From enrollment
Biological data - uraemic toxins - beta2-microglobulin
Time frame: From enrollment to the end of treatment at 7 weeks
Biological data - uraemic toxins - Indoxyl sulfate
Time frame: From enrollment to the end of treatment at 7 weeks
Biological data - uraemic toxins - p-Cresyl sulfate
Time frame: From enrollment to the end of treatment at 7 weeks
Biological data - uraemic toxins - myoglobin
Time frame: From enrollment to the end of treatment at 7 weeks
Biological data - uraemic toxins - free light chains
Time frame: From enrollment to the end of treatment at 7 weeks
Biological data - cardiac biomarkers - NT-pro-BNP
Time frame: From enrollment to the end of treatment at 7 weeks
Biological data - cardiac biomarkers - BNP level
Time frame: From enrollment to the end of treatment at 7 weeks
Biological data - cardiac biomarkers - cardiac troponin T
Time frame: From enrollment to the end of treatment at 7 weeks
Biological data - cardiac biomarkers - sST2
Time frame: From enrollment to the end of treatment at 7 weeks
biological data - characterization of patients - sodium
Time frame: From enrollment
biological data - characterization of patients - potassium
Time frame: From enrollment
biological data - characterization of patients - calcium
Time frame: From enrollment
biological data - characterization of patients - phosphate
Time frame: From enrollment
biological data - characterization of patients - vitamin D
Time frame: From enrollment
biological data - characterization of patients - parathyroid hormone
Time frame: From enrollment
biological data - characterization of patients - creatinine
Time frame: From enrollment
biological data - characterization of patients - creatinine clearance
Time frame: From enrollment
biological data - characterization of patients - urea
Time frame: From enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laure Patrier, MD, PhD principal investigator
AIDER Santé - Fondation Charles Mion
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischaemic preconditioning, Exercise and standard dialysis in people with Hemodialysis, run by University of Avignon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in regional myocardial stunning. (time frame: From enrollment to the end of treatment at 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.