Clinical trial NCT04831021: Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role?
Official title: Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Chronic kidney disease on dialysis
Physical exercise
Regional myocardial function
Myocardial stunning
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: AIDER- Santé
name: Avignon University (EA4278 - LaPEC)
name: Pr Philippe OBERT
name: Dr Claire MAUFRAIS
First posted: 2021-04-05
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.


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
* BMI\> 35
* Patient with automatic implantable defibrillator
* Heart transplant
* Uncontrolled high blood pressure
* Ejection fraction \<45%
* Unstabilized coronaries
* Non-contributory stress ultrasound

Primary outcomes:
measure: Change in regional myocardial function and myocardial stunning
timeFrame: Weekly over a period of 3 weeks
Secondary outcomes:
measure: Change in blood viscosity
timeFrame: Weekly over a period of 3 weeks
measure: Change in arterial stiffness
timeFrame: Weekly over a period of 3 weeks
measure: Change in sinus rhythm
timeFrame: Weekly over a period of 3 weeks
measure: Change in dialysis efficacy
timeFrame: Weekly over a period of 3 weeks
measure: Change in inflammatory markers
timeFrame: Weekly over a period of 3 weeks
measure: Change in mineral and bone metabolism markers
timeFrame: Weekly over a period of 3 weeks
measure: Change in myokines
timeFrame: Weekly over a period of 3 weeks
measure: Change in cardiac remodeling markers
timeFrame: Weekly over a period of 3 weeks
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Lapeyronie Hospital clinical trials Department
state: Hérault
city: Montpellier
country: France
facility: AIDER Santé
Study officials:
affiliation: CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
name: Jean Paul CRISTOL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU ADV, Department of Cardiology, Montpellier, FRANCE
name: François ROUBILLE, MD, PhD
role: STUDY_CHAIR
affiliation: AIDER Santé, Montpellier, FRANCE
name: Cécile TURC-BARON, MD
role: STUDY_CHAIR
affiliation: CHU ADV, Department of Cardiology, Montpellier, FRANCE
name: Jérôme ADDA, MD
role: STUDY_CHAIR
References: