RecruitingNot ApplicableNCT07269379

Intradialytic Exercise With Blood Flow Restriction in Hemodialysis Patients

Intradialytic Exercise With Blood Flow Restriction by Vascular Occlusion: A New Strategy for Cardioprotection in Hemodialysis Patients


Sponsor

University of Avignon

Enrollment

108 participants

Start Date

Nov 6, 2025

Study Type

INTERVENTIONAL

Conditions

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 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: 1. 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; 2. 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.


Eligibility

Min Age: 20 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether doing specially designed leg exercises with blood flow restriction during hemodialysis sessions (kidney dialysis) can help improve muscle strength and physical fitness in people on long-term dialysis. **You may be eligible if...** - You are between 20 and 79 years old - You have been receiving hemodialysis for more than 3 months - You do not currently exercise regularly outside of dialysis - You have not done any exercise programs during dialysis in the past 6 months - There are no medical reasons preventing you from exercising - Your life expectancy is at least 6 months **You may NOT be eligible if...** - You have unstable heart (coronary artery) disease - You have severe peripheral artery disease (poor circulation in your legs, stage III or IV) - You have had a limb amputation - You have a pacemaker, heart stimulator, or implanted defibrillator (ICD) - You have had a heart transplant - You have uncontrolled high blood pressure - You have severe anemia that does not respond to treatment - You are at high risk for deep vein thrombosis (blood clots in the legs) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERChronic phase - HDEX/HDBFRE

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

OTHERAcute phase - HDEX/HDBFRE

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


Locations(2)

CHU Strasbourg

Strasbourg, France

Medipole Lyon

Villeurbanne, France

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NCT07269379


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