Dialysis PatientsERO-CARDNCT07269379
Intradialytic Exercise With Blood Flow Restriction in Hemodialysis Patients
A study testing Chronic phase - HDEX/HDBFRE and Acute phase - HDEX/HDBFRE in people with Dialysis Patients, run by University of Avignon at 2 sites in France.
Trial summary
The main objective is to evaluate in hemodialysis patients the effects of two intradialytic rehabilitation programs based on physical exercise, with or without the application of blood flow restriction, on myocardial stunning and morpho-functional cardiac remodelling, compared with usual care (i.e., dialysis without… Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Dialysis Patients
- What is being tested?
- Chronic phase - HDEX/HDBFRE and Acute phase - HDEX/HDBFRE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Nov 2025to 6 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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.
- Patients stratified as high risk for deep venous thrombosis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
CHU Strasbourg
Strasbourg
Nans Florens, PhD, 0033681250605, nans.florens@chru-strasbourg.fr
- Recruiting
Medipole Lyon
Villeurbanne, 69100
Thomas Fournier, PhD, 0033 6 81 15 80 50, tfournier12@gmail.com
About this study
Official title: Intradialytic Exercise With Blood Flow Restriction by Vascular Occlusion: A New Strategy for Cardioprotection in Hemodialysis Patients
The main objective is to evaluate in hemodialysis patients the effects of two intradialytic rehabilitation programs based on physical exercise, with or without the application of blood flow restriction, on myocardial stunning and morpho-functional cardiac remodelling, compared with usual care (i.e., dialysis without exercise). In addition, the investigators will also assess the acute effects (i.e., a single session for each condition) of physical exercise, with or without blood flow restriction, on myocardial stunning at the end of dialysis.
In comparison with a conventional exercise program, the combination of physical exercise with blood flow restriction, which synergistically and additively activates intramuscular signalling pathways related to both exercise and ischaemia, is hypothesised to result in:
Read more
- A greater intradialytic cardioprotection, as demonstrated by a greater reduction in myocardial stunning at the end of dialysis (both in acute and chronic applications), with underlying mechanisms involving systemic and neuro-humoral pathways;
- Significant improvements in morpho-functional cardiac remodelling, attenuation of arrhythmic disturbances, and enhancement of aerobic capacity, muscle strength, and muscle mass-effects not observed with exercise alone without blood flow restriction, considering the low exercise intensity used in the current rehabilitation program (chronic application only).
This is a three-arm randomised clinical trial with parallel groups: standard hemodialysis (HD-CONTChro), a rehabilitation program with intradialytic exercise without vascular occlusion (HD-EXChro), and a rehabilitation program with intradialytic exercise with vascular occlusion (HD-BFREChro), with a 1:1:1 allocation ratio.
To investigate the acute effects of the interventions, all patients will undergo, in a randomized order, one session of each of the three dialysis modalities-standard hemodialysis (HD-CONTacute), hemodialysis with exercise without vascular restriction (HD-EXacute), and hemodialysis with exercise with vascular restriction (HD-BFREacute)-prior to initiation of the chronic phase of the study.
- Conditions
- Dialysis Patients
- Being tested
- Chronic phase - HDEX/HDBFRE, Acute phase - HDEX/HDBFRE
- Keywords
- end stage renal disease, hemodialysis, blood flow restriction exercise, intradialytic exercise, regional myocardial function, hemorheology
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic phase - HDEX/HDBFREOther
30 min of intradialytic cycling at a moderate intensity (12-14) , starting 30min after HD onset. 3 times a week for 12 weeks. No vascular occlusion for HDEXChro. Pressure at 50% of limb occlusion pressure on both legs for HDBFREChro
Acute phase - HDEX/HDBFREOther
30 min of intradialytic cycling at a moderate intensity (12-14) , starting 30min after HD onset. No vascular occlusion for HDEXacute. Pressure at 50% of limb occlusion pressure on both legs for HDBFREacute
| Study group | Role | What they receive |
|---|---|---|
| Experimental: HD-EXChro | Experimental | Will be enrolled in a 12 weeks intradialytic exercise program without vascular occlusion Receives: Other: Chronic phase - HDEX/HDBFRE; Other: Acute phase - HDEX/HDBFRE |
| Experimental: HD-BFREChro | Experimental | Will be enrolled in a 12 weeks intradialytic exercise program with vascular occlusion Receives: Other: Chronic phase - HDEX/HDBFRE; Other: Acute phase - HDEX/HDBFRE |
| Control | No intervention | Patients with standard HD (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of regional wall motion abnormalities (RWMAs)
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 the change in regional wall motion abnormalities (RWMAs) at peak stress of dialysis (i.e. 30 min before its end), in a standard HD, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
For the acute phase, the investigators will compare the number of RWMAs measured 30min before the end of each HD session between the 3 conditions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Secondary outcomes (80)
Change in LV longitudinal strains
Using speckle tracking echocardiography, the investigators will assess variations in LV longitudinal strains during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the changes in left ventricular (LV) longitudinal strain kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in RV longitudinal strains
Using speckle tracking echocardiography, the investigators will assess variations in RV longitudinal strains during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the changes in right ventricular (RV) longitudinal strain kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in LA longitudinal strains
Using speckle tracking echocardiography, the investigators will assess variations in LA longitudinal strains during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the changes in left atrial (LA) longitudinal strain kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in global constructive work
The investigators will assess variations in global constructive work during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Global constructive work (GCW, expressed in mmHg%) will be measured using speckle-tracking echocardiography from the pressure-longitudinal strain loop generated with the dedicated module provided by the ultrasound vendor. GCW represents the work performed during shortening in systole adding negative work during lengthening in isovolumetric relaxation.
For the acute phase, the investigators will compare the changes in LV global constructive work kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in global wasted work
The investigators will assess variations in global wasted work during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
Global wasted work (GWW, expressed in mmHg%) will be measured using speckle-tracking echocardiography from the pressure-longitudinal strain loop generated with the dedicated module provided by the ultrasound vendor. GWW represents the negative work performed during lengthening in systole adding work performed during shortening in isovolumetric relaxation.
For the acute phase, the investigators will compare the changes in LV global wasted work kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in global work efficiency
The investigators will assess variations in global work efficiency during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Global work efficiency (GWE, expressed in %) will be measured using speckle-tracking echocardiography from the pressure-longitudinal strain loop generated with the dedicated module provided by the ultrasound vendor. GWE will be calculated as follow: Global constructive work divided by the sum of global constructive and wasted work.
For the acute phase, the investigators will compare the changes in LV global work efficiency kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in global myocardial work
The investigators will assess variations in global myocardial work during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
Global myocardial work (GMM, expressed in %) will be measured using speckle-tracking echocardiography from the pressure-longitudinal strain loop generated with the dedicated module provided by the ultrasound vendor. GMM represents the area of the Longitudinal strain-pressure loop.
For the acute phase, the investigators will compare the changes in LV global myocardial work kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in left intraventricular pressure gradient
The investigators will assess variations in the left intraventricular pressure gradient, measured by postprocessing color Doppler M-mode echocardiographic images during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
For the acute phase, the investigators will compare the changes in LV intraventricular pressure gradient kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in LV diameter
The investigators will assess variations in left ventricular (LV) diameter at end-systole and end-diastole, measured using Doppler M-mode echocardiography, before a standard dialysis session, before and after the 12-week program. (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
Measured: From enrollment to the end of the program at 19 weeks
Change in LV wall thicknessess
The investigators will assess variations in the LV wall thicknessess, measured by Doppler M-mode echocardiographic images before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
Measured: From enrollment to the end of the program at 19 weeks
Change in LV volumes
The investigators will assess variations in left ventricular (LV) volumes at end-systole and end-diastole, measured using echocardiography before a standard dialysis session, before and after the 12-week program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
Measured: From enrollment to the end of the program at 19 weeks
Change in LV mass
The investigators will assess variations in the LV mass measured using echocardiography before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the LV morphology of the patients.
Measured: From enrollment to the end of the program at 19 weeks
Change in LV global systolic function (ejection fraction)
The investigators will assess variations in the LV ejection fraction measured using echocardiography before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the LV global systolic function of the patients.
Measured: From enrollment to the end of the program at 19 weeks
Change in LV s' wave
The investigators will assess variations in the LV s' wave measured by tissue Doppler imaging before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the LV regional function of the patients.
Measured: From enrollment to the end of the program at 19 weeks
Change in LV e' wave
The investigators will assess variations in the LV e' wave measured by tissue Doppler imaging before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the LV regional diastolic function of the patients.
Measured: From enrollment to the end of the program at 19 weeks
Change in LV a' wave
The investigators will assess variations in the LV a' wave measured by tissue Doppler imaging before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the LV regional diastolic function of the patients.
Measured: From enrollment to the end of the program at 19 weeks
Change in LV E wave (global diastolic function)
The investigators will assess variations in the LV E wave measured by pulsed Doppler ehocardiography during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
For the acute phase, the investigators will compare the change in LV E wave throughout the dialysis (eg before and 30min before the end of each HD) between 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute). LV E is an index of global diastolic function, characterising the LV early filling.
Measured: From enrollment to the end of the program at 19 weeks
Change in LV A wave (global diastolic function)
The investigators will assess variations in the LV A wave measured by pulsed Doppler ehocardiography during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
For the acute phase, the investigators will compare the change in LV A wave throughout the dialysis (eg before and 30min before the end of each HD) between 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute). LV A is an index of global diastolic function, characterising the LV late filling.
Measured: From enrollment to the end of the program at 19 weeks
Change in LV E/e'
The investigators will assess variations in the LV E/e' ratio measured before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the LV filling pressure of the patients.
Measured: From enrollment to the end of the program at 19 weeks
Change in RV areas
The investigators will assess variations in the RV area at end-systole and end-diastole measured before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the RV morphology and function of the patients.
Measured: From enrollment to the end of the program at 19 weeks
Change in RV systolic function
The investigators will assess variations in the RV fractional area measured using echocardiography before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the RV global systolic function of the patients.
Measured: From enrollment to the end of the program at 19 weeks
Change in RV systolic function 2
The investigators will assess variations in the Tricuspid Annular Plane Systolic Excursion measured using echocardiography before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the RV global systolic function of the patients.
Measured: From enrollment to the end of the program at 19 weeks
Change in RV areas
The investigators will assess variations in the RV area at end-systole and end-diastole before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the RV morphology and function of the patients.
Measured: From enrollment to the end of the program at 19 weeks
Change in RV diameter
The investigators will assess variations in the RV diameter and end-systole and end-diastole, measured by Doppler M-mode echocardiographic images before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
Measured: From enrollment to the end of the program at 19 weeks
Change in RV Et wave
The investigators will assess variations in the RV Et wave by pulsed Doppler ehocardiography images before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). It will be used to characterize RV global diastolic function.
Measured: From enrollment to the end of the program at 19 weeks
Change in RV At wave
The investigators will assess variations in the RV At wave by pulsed Doppler ehocardiography images before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). It will be used to characterize RV global diastolic function.
Measured: From enrollment to the end of the program at 19 weeks
Change in RV Et/At ratio
The investigators will assess variations in the RV Et/At ratio before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). It will be used to characterize RV global diastolic function.
Measured: From enrollment to the end of the program at 19 weeks
Change in RV e'
The investigators will assess variations in the RV e' wave by tissue Doppler imaging before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). It will be used to characterize RV regional diastolic function.
Measured: From enrollment to the end of the program at 19 weeks
Change in RV a'
The investigators will assess variations in the RV a' wave by tissue Doppler imaging before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). It will be used to characterize RV regional diastolic function.
Measured: From enrollment to the end of the program at 19 weeks
Change in RV s'
The investigators will assess variations in the RV s' wave by tissue Doppler imaging before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). It will be used to characterize RV regional systolic function.
Measured: From enrollment to the end of the program at 19 weeks
Change in tricuspid regurgitation
The investigators will assess variations in the tricuspid regurgitation by continuous-wave Doppler ehocardiography before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). It will be used to characterize LV global diastolic function.
Measured: From enrollment to the end of the program at 19 weeks
Change in RV Et/e'
The investigators will assess variations in the RV Et/e' ratio before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the RV filling pressure of the patients.
Measured: From enrollment to the end of the program at 19 weeks
Change in LA morphology and function
The investigators will assess variations in the LA volumes measured before and at end of a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the LA morphology and function of the patients.
Measured: From enrollment to the end of the program at 19 weeks
Change in blood pressure
The investigators will measure blood pressure every 30min during a standard dialysis (i.e. from the beginning to the end of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Their aim is to compare the changes during HD among the three groups.
For the acute phase, the investigators will compare the change in blood pressure every 30min from the beginning to the end of HD across the three experimental conditions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in cardiac output
The investigators will measure cardiac output every 30min during a standard dialysis (i.e. from the beginning to the end of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Their aim is to compare the changes during HD among the three groups.
For the acute phase, the investigators will compare the change in cardiac output every 30min from the beginning to the end of HD across the three experimental conditions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in stroke volume
The investigators will measure stroke volume every 30min during a standard dialysis (i.e. from the beginning to the end of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Their aim is to compare the changes during HD among the three groups.
For the acute phase, the investigators will compare the change in stroke volume every 30min from the beginning to the end of HD across the three experimental conditions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in heart rate
The investigators will measure heart rate every 30min during a standard dialysis (i.e. from the beginning to the end of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Their aim is to compare the changes during HD among the three groups.
For the acute phase, the investigators will compare the change in heart rate every 30min from the beginning to the end of HD across the three experimental conditions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in blood level of sodium
The investigators will assess variations in blood level of sodium before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of 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 to the end of the program at 19 weeks
Change in blood level of potassium
The investigators will assess variations in blood level of potassium before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of 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 to the end of the program at 19 weeks
Change in blood level of calcium
The investigators will assess variations in blood level of calcium before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of 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 to the end of the program at 19 weeks
Change in blood level of phosphate
The investigators will assess variations in blood level of phosphate before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of 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 to the end of the program at 19 weeks
Change in blood level of vitamin D
The investigators will assess variations in blood level of vitamin D before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of 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 to the end of the program at 19 weeks
Change in blood level of parathyroid hormone
The investigators will assess variations in blood level of parathyroid hormone before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of 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 to the end of the program at 19 weeks
Change in blood level of creatinine
The investigators will assess variations in blood level of creatinine before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of 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 to the end of the program at 19 weeks
Change in creatinine clearance
The investigators will assess variations in creatinine clearance before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of 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 to the end of the program at 19 weeks
Change in blood level of urea
The investigators will assess variations in blood level of urea before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of 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 to the end of the program at 19 weeks
Change in serum level of albumin
The investigators will assess variations in serum level of albumin before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of 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 to the end of the program at 19 weeks
Change in normalized proteïn catabolic rate
The investigators will assess variations in normalized proteïn catabolic rate before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of 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 to the end of the program at 19 weeks
Change in Kt/V
The investigators will assess variations in Kt/V before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of the patients.
Measured: From enrollment to the end of the program at 19 weeks
Change in serum level of c-reactive protein
The investigators will assess variations in serum level of c-reactive protein before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of 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 to the end of the program at 19 weeks
Change in complete blood count
The investigators will assess variations in complete blood count before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the blood of 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 to the end of the program at 19 weeks
Change in serum level of ferritin
The investigators will assess variations in serum level of ferritin before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the blood of 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 to the end of the program at 19 weeks
Change in transferrin saturation
The investigators will assess variations in transferrine saturation before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the blood of 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 to the end of the program at 19 weeks
Change in LDL cholesterol
The investigators will assess variations in LDL cholesterol before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the lipidic profile of 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 to the end of the program at 19 weeks
Change in HDL cholesterol
The investigators will assess variations in HDL cholesterol before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the lipidic profile of 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 to the end of the program at 19 weeks
Change in triglyceride level
The investigators will assess variations in triglyceride level before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the lipidic profile of 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 to the end of the program at 19 weeks
Change in hematocrit
The investigators will assess variations in hematocrit, measured using an hemoglobinometer, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in hematocrit kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in hemoglobin level
The investigators will assess variations in hemoglobin, measured using an hemoglobinometer, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in hemoglobin kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in interleukin-6 level
The investigators will assess variations in interleukin-6 level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in interleukin-6 kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in interleukin-10 level
The investigators will assess variations in interleukin-10 level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in interleukin-10 kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in tumor necrosis factor-α level
The investigators will assess variations in tumor necrosis factor-α level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in tumor necrosis factor-α kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in ultra-sensitive c-reactive protein level
The investigators will assess variations in ultra-sensitive c-reactive protein level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in C-reactive protein kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in intercellular adhesion molecule-1 level
The investigators will assess variations in intercellular adhesion molecule-1 level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in intercellular adhesion molecule-1 level kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in vascular cell adhesion molecule-1 level
The investigators will assess variations in vascular cell adhesion molecule-1 level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in vascular cell adhesion molecule-1 kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in endothelin level
The investigators will assess variations in endothelin level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in endothelin kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in proendothelin level
The investigators will assess variations in proendothelin level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in pro-endothelin kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in NT-pro-BNP level
The investigators will assess variations in NT-pro-BNP level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in NT-pro-BNPkinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in BNP level
The investigators will assess variations in BNP level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in BNP kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in cardiac troponin T level
The investigators will assess variations in cardiac troponin T level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in cardiac troponin T kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in levels of soluble ST2
The investigators will assess variations in levels of soluble ST2, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in soluble ST2 kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in beta2-microglobulin level
The investigators will assess variations in beta2-microglobulin level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in beta2-microglobulin kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in indoxyl sulfate level
The investigators will assess variations in indoxyl sulfate level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in indoxyl sulfate kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in p-Cresyl sulfate level
The investigators will assess variations in p-Cresyl sulfate level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in p-cresyl sulfate kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in myoglobin level
The investigators will assess variations in myoglobin level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in myoglobin kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in free light chains
The investigators will assess variations in cardiac free light chains, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in cardiac free light chain kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in whole blood viscosity
The investigators will assess variations in whole blood viscosity, measured using a cone-plate viscometer, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in whole blood viscosity kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in erythrocyte deformability
The investigators will assess variations in erythrocyte deformability, measured using an ektacytometer, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in erythrocyte deformability kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in erythrocyte aggregation
The investigators will assess variations in erythrocyte aggregation, measured using an ektacytometer, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in erythrocyte aggregation kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in fibrinogen level
The investigators will assess variations in fibrinogen level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in fibrinogen kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Change in miRNA
The investigators will assess variations in levels of circulating mi-RNAs, quantified by reverse transcription-quantitative polymerase chain reaction (RT-qPCR), during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).
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.
For the acute phase, the investigators will compare the change in circulating miRNA kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
Measured: From enrollment to the end of the program at 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start6 Nov 2025
- Primary completion6 May 2028 (estimated)
- Study completion6 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis PatientsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Acute phase: 3 sessions per patient, realized in a random order : * standard HD (HD-CONTacute) * HD with acute intradialytic exercise without vascular occlusion (HD-EXacute) * HD with acute intradialytic exercise with vascular occlusion (HD-BFREacute). 2. Chronic phase: patients randomly assigned to one of the following 3 groups (ration 1:1:1): an exercise training program without (HD-EXChro) or with (HD-BFREChro) vascular occlusion, standard HD (HD-CONTChro) without exercise. Patients will be evaluated before and after 12 weeks of exercise rehabilitation (HD-EXChro, HD-BFREChro) or standard dialysis (HD-CONTChro).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Avignon
- Sponsor type
- University, hospital or other
- Collaborators
- Médipôle Lyon-Villeurbanne, Nouvel Hôpital Civil, 1 place de l'Hôpital 67091 Strasbourg cedex
- Responsible party
- Sponsor
- Investigators
- Nans Florens, PhD, Principal investigator, CHU Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269379
- Sponsor's protocol ID
- AU-092025-CM
- Other IDs
- LAPEC/2025/ERO-CARD
- Acronym
- ERO-CARD
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 8 Dec 2025
- 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 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradialytic Exercise With Blood Flow Restriction by Vascular Occlusion: A New Strategy for Cardioprotection in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07269379
- Acronym / sponsor ID
- ERO-CARD / AU-092025-CM
- Conditions
- Dialysis Patients
- Keywords
- end stage renal disease, hemodialysis, blood flow restriction exercise, intradialytic exercise, regional myocardial function, hemorheology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of AvignonUniversity, hospital or other
- Collaborators
- Médipôle Lyon-Villeurbanne, Nouvel Hôpital Civil, 1 place de l'Hôpital 67091 Strasbourg cedex
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 6 May 2028 (estimated)
- Study completion
- 6 Oct 2028 (estimated)
- First posted
- 8 Dec 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 main objective is to evaluate in hemodialysis patients the effects of two intradialytic rehabilitation programs based on physical exercise, with or without the application of blood flow restriction, on myocardial stunning and morpho-functional cardiac remodelling, compared with usual care (i.e., dialysis without exercise). In addition, the investigators will also assess the acute effects (i.e., a single session for each condition) of physical exercise, with or without blood flow restriction, on myocardial stunning at the end of dialysis.
In comparison with a conventional exercise program, the combination of physical exercise with blood flow restriction, which synergistically and additively activates intramuscular signalling pathways related to both exercise and ischaemia, is hypothesised to result in:
- A greater intradialytic cardioprotection, as demonstrated by a greater reduction in myocardial stunning at the end of dialysis (both in acute and chronic applications), with underlying mechanisms involving systemic and neuro-humoral pathways;
- Significant improvements in morpho-functional cardiac remodelling, attenuation of arrhythmic disturbances, and enhancement of aerobic capacity, muscle strength, and muscle mass-effects not observed with exercise alone without blood flow restriction, considering the low exercise intensity used in the current rehabilitation program (chronic application only).
This is a three-arm randomised clinical trial with parallel groups: standard hemodialysis (HD-CONTChro), a rehabilitation program with intradialytic exercise without vascular occlusion (HD-EXChro), and a rehabilitation program with intradialytic exercise with vascular occlusion (HD-BFREChro), with a 1:1:1 allocation ratio.
To investigate the acute effects of the interventions, all patients will undergo, in a randomized order, one session of each of the three dialysis modalities-standard hemodialysis (HD-CONTacute), hemodialysis with exercise without vascular restriction (HD-EXacute), and hemodialysis with exercise with vascular restriction (HD-BFREacute)-prior to initiation of the chronic phase of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 1. Acute phase: 3 sessions per patient, realized in a random order : * standard HD (HD-CONTacute) * HD with acute intradialytic exercise without vascular occlusion (HD-EXacute) * HD with acute intradialytic exercise with vascular occlusion (HD-BFREacute). 2. Chronic phase: patients randomly assigned to one of the following 3 groups (ration 1:1:1): an exercise training program without (HD-EXChro) or with (HD-BFREChro) vascular occlusion, standard HD (HD-CONTChro) without exercise. Patients will be evaluated before and after 12 weeks of exercise rehabilitation (HD-EXChro, HD-BFREChro) or standard dialysis (HD-CONTChro).
| Arm | Type | Receives |
|---|---|---|
| Experimental: HD-EXChro | Experimental | Other: Chronic phase - HDEX/HDBFRE, Other: Acute phase - HDEX/HDBFREWill be enrolled in a 12 weeks intradialytic exercise program without vascular occlusion |
| Experimental: HD-BFREChro | Experimental | Other: Chronic phase - HDEX/HDBFRE, Other: Acute phase - HDEX/HDBFREWill be enrolled in a 12 weeks intradialytic exercise program with vascular occlusion |
| Control | No intervention | –Patients with standard HD (usual care) |
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 (13 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 |
|---|---|---|
| Chronic phase - HDEX/HDBFRE30 min of intradialytic cycling at a moderate intensity (12-14) , starting 30min after HD onset. 3 times a week for 12 weeks. No vascular occlusion for HDEXChro. Pressure at 50% of limb occlusion pressure on both legs for HDBFREChro | Other | Experimental: HD-BFREChro, Experimental: HD-EXChro |
| Acute phase - HDEX/HDBFRE30 min of intradialytic cycling at a moderate intensity (12-14) , starting 30min after HD onset. No vascular occlusion for HDEXacute. Pressure at 50% of limb occlusion pressure on both legs for HDBFREacute | Other | Experimental: HD-BFREChro, Experimental: HD-EXChro |
Primary outcome
Change in the number of regional wall motion abnormalities (RWMAs)
Time frame: From enrollment to the end of the program at 19 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 the change in regional wall motion abnormalities (RWMAs) at peak stress of dialysis (i.e. 30 min before its end), in a standard HD, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). For the acute phase, the investigators will compare the number of RWMAs measured 30min before the end of each HD session between the 3 conditions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
80 secondary outcomes
Change in LV longitudinal strains
Time frame: From enrollment to the end of the program at 19 weeks
Change in RV longitudinal strains
Time frame: From enrollment to the end of the program at 19 weeks
Change in LA longitudinal strains
Time frame: From enrollment to the end of the program at 19 weeks
Change in global constructive work
Time frame: From enrollment to the end of the program at 19 weeks
Change in global wasted work
Time frame: From enrollment to the end of the program at 19 weeks
Change in global work efficiency
Time frame: From enrollment to the end of the program at 19 weeks
Change in global myocardial work
Time frame: From enrollment to the end of the program at 19 weeks
Change in left intraventricular pressure gradient
Time frame: From enrollment to the end of the program at 19 weeks
Change in LV diameter
Time frame: From enrollment to the end of the program at 19 weeks
Change in LV wall thicknessess
Time frame: From enrollment to the end of the program at 19 weeks
Change in LV volumes
Time frame: From enrollment to the end of the program at 19 weeks
Change in LV mass
Time frame: From enrollment to the end of the program at 19 weeks
Change in LV global systolic function (ejection fraction)
Time frame: From enrollment to the end of the program at 19 weeks
Change in LV s' wave
Time frame: From enrollment to the end of the program at 19 weeks
Change in LV e' wave
Time frame: From enrollment to the end of the program at 19 weeks
Change in LV a' wave
Time frame: From enrollment to the end of the program at 19 weeks
Change in LV E wave (global diastolic function)
Time frame: From enrollment to the end of the program at 19 weeks
Change in LV A wave (global diastolic function)
Time frame: From enrollment to the end of the program at 19 weeks
Change in LV E/e'
Time frame: From enrollment to the end of the program at 19 weeks
Change in RV areas
Time frame: From enrollment to the end of the program at 19 weeks
Change in RV systolic function
Time frame: From enrollment to the end of the program at 19 weeks
Change in RV systolic function 2
Time frame: From enrollment to the end of the program at 19 weeks
Change in RV areas
Time frame: From enrollment to the end of the program at 19 weeks
Change in RV diameter
Time frame: From enrollment to the end of the program at 19 weeks
Change in RV Et wave
Time frame: From enrollment to the end of the program at 19 weeks
Change in RV At wave
Time frame: From enrollment to the end of the program at 19 weeks
Change in RV Et/At ratio
Time frame: From enrollment to the end of the program at 19 weeks
Change in RV e'
Time frame: From enrollment to the end of the program at 19 weeks
Change in RV a'
Time frame: From enrollment to the end of the program at 19 weeks
Change in RV s'
Time frame: From enrollment to the end of the program at 19 weeks
Change in tricuspid regurgitation
Time frame: From enrollment to the end of the program at 19 weeks
Change in RV Et/e'
Time frame: From enrollment to the end of the program at 19 weeks
Change in LA morphology and function
Time frame: From enrollment to the end of the program at 19 weeks
Change in blood pressure
Time frame: From enrollment to the end of the program at 19 weeks
Change in cardiac output
Time frame: From enrollment to the end of the program at 19 weeks
Change in stroke volume
Time frame: From enrollment to the end of the program at 19 weeks
Change in heart rate
Time frame: From enrollment to the end of the program at 19 weeks
Change in blood level of sodium
Time frame: From enrollment to the end of the program at 19 weeks
Change in blood level of potassium
Time frame: From enrollment to the end of the program at 19 weeks
Change in blood level of calcium
Time frame: From enrollment to the end of the program at 19 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- 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.
Nans Florens, PhD principal investigator
CHU Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic phase - HDEX/HDBFRE and Acute phase - HDEX/HDBFRE in people with Dialysis Patients, run by University of Avignon at 2 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 13 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: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Obert, PhD (0033698050446, philippe.obert@univ-avignon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of regional wall motion abnormalities (RWMAs) (time frame: From enrollment to the end of the program at 19 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 8 Dec 2025.