Intradialytic Exercise and Remote Ischaemic Preconditioning: a Cardioprotective Role ?
NCT ID: NCT06856512
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
46 participants
INTERVENTIONAL
2025-02-17
2025-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients issued from dialysis units (clinic)
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.
Remote ischaemic preconditioning
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).
Exercise
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 dialysis
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.
Interventions
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Remote ischaemic preconditioning
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).
Exercise
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 dialysis
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.
Eligibility Criteria
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Inclusion Criteria
* Patients on hemodialysis for more than 3 months.
* No engagement in regular exercise outside of dialysis.
* No prior exposure to intradialytic exercise within the past six months.
* No medical contraindications to physical activity.
* Life expectancy greater than 6 months.
* Patients with relative good echogenicity
Exclusion Criteria
* The patient is in an exclusion period determined by a previous study
* The patient is under legal protection or under guardianship or curatorship It turns out to be impossible to give the patient informed information, or the patient refuses to sign the consent
* Pregnant, parturient or breastfeeding patient
* Patients with unstable coronary artery disease.
* Patients with peripheral artery disease (stage III or IV) in the lower limbs.
* Patients with limb amputation.
* Patients with musculoskeletal disorders impairing exercise.
* Presence of a pacemaker, cardiac stimulation device, or implantable cardioverter defibrillator (ICD).
* History of heart transplant.
* Patients with uncontrolled hypertension.
* Refractory anemia.
20 Years
79 Years
ALL
No
Sponsors
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University of Avignon
OTHER
Responsible Party
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Principal Investigators
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Laure Patrier, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
AIDER Santé - Fondation Charles Mion
Locations
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Aider Sante
Montpellier, , France
Aider Sante
Nîmes, , France
CHU Strasbourg
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LAPEC/2024/DIAL
Identifier Type: OTHER
Identifier Source: secondary_id
AU-092024-CM
Identifier Type: -
Identifier Source: org_study_id
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