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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Unknown

Conditions

Chronic Kidney Diseases

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04831021
RECHMPL20_0462

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 1 patient group

Patients issued from dialysis units (clinic)
Experimental group
Treatment:
Procedure: Dialysis without physical exercise
Procedure: Dialysis with per-dialytic physical exercise
Procedure: Dialysis with pre-dialytic physical exercise

Trial contacts and locations

2

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Central trial contact

Jean Paul CRISTOL, MD, PhD

Data sourced from clinicaltrials.gov

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