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Clinical Trials/NCT04831021
NCT04831021
Unknown
Not Applicable

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

University Hospital, Montpellier2 sites in 1 country32 target enrollmentSeptember 24, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Diseases
Sponsor
University Hospital, Montpellier
Enrollment
32
Locations
2
Primary Endpoint
Change in regional myocardial function and myocardial stunning
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 24, 2021
End Date
April 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in regional myocardial function and myocardial stunning

Time Frame: Weekly over a period of 3 weeks

Secondary Outcomes

  • 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)

Study Sites (2)

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