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

NCT04831021 | Unknown

• 1 other identifier: RECHMPL20_0462
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Kidney Diseases

Keywords

Chronic kidney disease on dialysis; Physical exercise; Regional myocardial function; Myocardial stunning

Outcome Measures

Primary Outcomes (1)

• Change in regional myocardial function and myocardial stunning

  Weekly over a period of 3 weeks

Secondary Outcomes (8)

• Change in blood viscosity

  Weekly over a period of 3 weeks

• Change in arterial stiffness

  Weekly over a period of 3 weeks

• Change in sinus rhythm

  Weekly over a period of 3 weeks

• Change in dialysis efficacy

  Weekly over a period of 3 weeks

• Change in inflammatory markers

  Weekly over a period of 3 weeks

Study Arms (1)

Patients issued from dialysis units (clinic)

EXPERIMENTAL

Procedure: Dialysis without physical exercise; Procedure: Dialysis with pre-dialytic physical exercise; Procedure: Dialysis with per-dialytic physical exercise

Interventions

Dialysis without physical exercise PROCEDURE

Hemodialysis control condition

Patients issued from dialysis units (clinic)

Dialysis with pre-dialytic physical exercise 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.

Patients issued from dialysis units (clinic)

Dialysis with per-dialytic physical exercise 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.

Patients issued from dialysis units (clinic)

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient is participating in another Category I interventional study, or has participated in another interventional study within the past 3 months
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• AIDER- Santé: collaborator
• Avignon University (EA4278 - LaPEC): collaborator
• Pr Philippe OBERT: collaborator
• Dr Claire MAUFRAIS: collaborator

Study Sites (2)

Lapeyronie Hospital clinical trials Department

Montpellier, Hérault, 34295, France

NOT YET RECRUITING

AIDER Santé

Montpellier, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 40794519 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity; Myocardial Stunning

Interventions

Dialysis; Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jean Paul CRISTOL, MD, PhD

  CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE

  PRINCIPAL INVESTIGATOR

• François ROUBILLE, MD, PhD

  CHU ADV, Department of Cardiology, Montpellier, FRANCE

  STUDY CHAIR

• Cécile TURC-BARON, MD

  AIDER Santé, Montpellier, FRANCE

  STUDY CHAIR

• Jérôme ADDA, MD

  CHU ADV, Department of Cardiology, Montpellier, FRANCE

  STUDY CHAIR

Central Study Contacts

Jean Paul CRISTOL, MD, PhD

CONTACT

04 67 33 83 14; jp-cristol@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: September 24, 2021
• Primary Completion: October 1, 2022
• Study Completion: April 1, 2023
• Last Updated: January 4, 2022

Record last verified: 2021-12

Locations

FR (2)