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

Not Applicable

• Conditions: Chronic Kidney Diseases
• Interventions: Procedure: Dialysis without physical exercise; Procedure: Dialysis with pre-dialytic physical exercise; Procedure: Dialysis with per-dialytic physical exercise

• Registration Number: NCT04831021
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-05
• Study Start: 2021-09-24
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-31
• Last Update Posted: 2022-01-04
• Primary Completion: 2022-10
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients issued from dialysis units (clinic)	Dialysis with pre-dialytic physical exercise	-
Patients issued from dialysis units (clinic)	Dialysis with per-dialytic physical exercise	-
Patients issued from dialysis units (clinic)	Dialysis without physical exercise	-

Primary Outcome Measures

Name	Time	Method
Change in regional myocardial function and myocardial stunning	Weekly over a period of 3 weeks

Secondary Outcome Measures

Name	Time	Method
Change in mineral and bone metabolism markers	Weekly over a period of 3 weeks
Change in blood viscosity	Weekly over a period of 3 weeks
Change in arterial stiffness	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 myokines	Weekly over a period of 3 weeks
Change in cardiac remodeling markers	Weekly over a period of 3 weeks
Change in sinus rhythm	Weekly over a period of 3 weeks

Trial Locations

Locations (2)

Lapeyronie Hospital clinical trials Department; 🇫🇷 Montpellier, Hérault, France

AIDER Santé; 🇫🇷 Montpellier, France