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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Procedure: Dialysis without physical exercise
* Procedure: Dialysis with pre-dialytic physical exercise
* Procedure: Dialysis with per-dialytic physical exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients issued from dialysis units (clinic)<br> | Procedure: Dialysis without physical exercise<br>* Hemodialysis control condition<br>Procedure: Dialysis with pre-dialytic physical exercise<br>* 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.<br>Procedure: Dialysis with per-dialytic physical exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease on dialysis, Physical exercise, Regional myocardial function, Myocardial stunning