Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role? (EXP DIAL)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Procedure: Dialysis without physical exercise; Procedure: Dialysis with pre-dialytic physical exercise; Procedure: Dialysis with per-dialytic physical exercise

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean Paul CRISTOL, MD, PhD; Phone Number: 04 67 33 83 14; Email: jp-cristol@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France
    • Recruiting
    • AIDER Santé
    • Contact: Cécile TURC-BARON, MD
  • Hérault
    • Montpellier, Hérault, France, 34295
      • Not yet recruiting
      • Lapeyronie Hospital clinical trials Department
      • Contact: Jean Paul CRISTOL, MD, PhD; Phone Number: 04 67 33 83 14; Email: jp-cristol@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients issued from dialysis units (clinic)

Procedure: Dialysis without physical exercise; Hemodialysis control condition; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in regional myocardial function and myocardial stunning	Weekly over a period of 3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change in mineral and bone metabolism markers	Weekly over a period of 3 weeks
Change in myokines	Weekly over a period of 3 weeks
Change in cardiac remodeling markers	Weekly over a period of 3 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: AIDER- Santé; Avignon University (EA4278 - LaPEC); Pr Philippe OBERT; Dr Claire MAUFRAIS
• Investigators: Principal Investigator: Jean Paul CRISTOL, MD, PhD, CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE; Study Chair: 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 record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 31, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Physical exercise; Myocardial stunning; Chronic kidney disease on dialysis; Regional myocardial function
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: RECHMPL20_0462

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No