Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role?

NCT ID: NCT04831021

Last Updated: 2022-01-04

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-24

Study Completion Date

2023-04-30

Brief Summary

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This study aims at evaluating, in chronic kidney disease patients on dialysis, the effect of acute per- or pre-dialytic physical exercise on regional myocardial function and myocardial stunning, blood viscosity, arterial stiffness, variability of sinus rhythm, dialysis efficacy, inflammation, mineral and bone disorders, myokines and cardiac remodeling markers.

Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All patients will be assigned to one dialysis session without physical exercise, one dialysis session with pre-dialytic physical exercise and one dialysis session with per-dialytic physical exercise in random order.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients issued from dialysis units (clinic)

Group Type EXPERIMENTAL

Dialysis without physical exercise

Intervention Type PROCEDURE

Hemodialysis control condition

Dialysis with pre-dialytic physical exercise

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient aged ≥ 20 to ≤ 79 years
* 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

* 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
* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AIDER- Santé

UNKNOWN

Sponsor Role collaborator

Avignon University (EA4278 - LaPEC)

UNKNOWN

Sponsor Role collaborator

Pr Philippe OBERT

UNKNOWN

Sponsor Role collaborator

Dr Claire MAUFRAIS

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status NOT_YET_RECRUITING

AIDER Santé

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean Paul CRISTOL, MD, PhD

Role: CONTACT

04 67 33 83 14

Facility Contacts

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Jean Paul CRISTOL, MD, PhD

Role: primary

04 67 33 83 14

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.

Reference Type DERIVED
PMID: 40794519 (View on PubMed)

Other Identifiers

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RECHMPL20_0462

Identifier Type: -

Identifier Source: org_study_id

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