Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role?
NCT ID: NCT04831021
Last Updated: 2022-01-04
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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UNKNOWN
NA
32 participants
INTERVENTIONAL
2021-09-24
2023-04-30
Brief Summary
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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)
Dialysis without physical exercise
Hemodialysis control condition
Dialysis with pre-dialytic physical exercise
Patients will pedal for 30 minutes using a ergometer directly attached to the dialysis bed. The exercise will be performed 60 minutes before connection to hemodialysis.
Dialysis with per-dialytic physical exercise
Patients will pedal for 30 minutes using a ergometer directly attached to the dialysis bed. The exercise will start 30 minutes after the start of dialysis.
Interventions
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Dialysis without physical exercise
Hemodialysis control condition
Dialysis with pre-dialytic physical exercise
Patients will pedal for 30 minutes using a ergometer directly attached to the dialysis bed. The exercise will be performed 60 minutes before connection to hemodialysis.
Dialysis with per-dialytic physical exercise
Patients will pedal for 30 minutes using a ergometer directly attached to the dialysis bed. The exercise will start 30 minutes after the start of dialysis.
Eligibility Criteria
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Inclusion Criteria
* Undernourished patient according to the ARNOS score : ≥ 2
* No medical contraindication to physical activity
* Life expectancy greater than 6 months
* Patient on hemodialysis for more than 3 months
* Patients with relatively 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
* Patient with a contraindication to retraining
* Patient with valvular heart disease, arteriopathy of the lower limbs stage III and IV, amputation or knee or hip prosthesis
* Patient with musculoskeletal problems
* Patient with severe respiratory failure
* Paired sleep apnea syndrome
* BMI\> 35
* Patient with automatic implantable defibrillator
* Heart transplant
* Uncontrolled high blood pressure
* Ejection fraction \<45%
* Unstabilized coronaries
* Non-contributory stress ultrasound
20 Years
79 Years
ALL
No
Sponsors
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AIDER- Santé
UNKNOWN
Avignon University (EA4278 - LaPEC)
UNKNOWN
Pr Philippe OBERT
UNKNOWN
Dr Claire MAUFRAIS
UNKNOWN
University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Jean Paul CRISTOL, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
François ROUBILLE, MD, PhD
Role: STUDY_CHAIR
CHU ADV, Department of Cardiology, Montpellier, FRANCE
Cécile TURC-BARON, MD
Role: STUDY_CHAIR
AIDER Santé, Montpellier, FRANCE
Jérôme ADDA, MD
Role: STUDY_CHAIR
CHU ADV, Department of Cardiology, Montpellier, FRANCE
Locations
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Lapeyronie Hospital clinical trials Department
Montpellier, Hérault, France
AIDER Santé
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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Cécile TURC-BARON, MD
Role: primary
References
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Josse M, Turc-Baron C, Patrier L, Connes P, Grandperrin A, Nottin S, Cristol JP, Hedon C, Roubille F, Maufrais C, Obert P. Acute Exercise before Dialysis Is as Cardioprotective as during Dialysis: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2025 Aug 12;20(9):1236-1246. doi: 10.2215/CJN.0000000767.
Other Identifiers
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RECHMPL20_0462
Identifier Type: -
Identifier Source: org_study_id
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