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

Chronic Kidney Diseases Clinical Trial

— EXP DIAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04831021
• Other study ID #: RECHMPL20_0462
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2021
• Est. completion date: April 2023

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: Jean Paul CRISTOL, MD, PhD
• Phone: 04 67 33 83 14
• Email: jp-cristol[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: April 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Procedure:
• Dialysis without physical exercise
Hemodialysis control condition
• Dialysis with pre-dialytic physical exercise
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.
• Dialysis with per-dialytic physical exercise
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.

Locations

Country	Name	City	State
France	AIDER Santé	Montpellier
France	Lapeyronie Hospital clinical trials Department	Montpellier	Hérault

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Montpellier	AIDER- Santé, Avignon University (EA4278 - LaPEC), Dr Claire MAUFRAIS, Pr Philippe OBERT

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in regional myocardial function and myocardial stunning		Weekly over a period of 3 weeks
Secondary	Change in blood viscosity		Weekly over a period of 3 weeks
Secondary	Change in arterial stiffness		Weekly over a period of 3 weeks
Secondary	Change in sinus rhythm		Weekly over a period of 3 weeks
Secondary	Change in dialysis efficacy		Weekly over a period of 3 weeks
Secondary	Change in inflammatory markers		Weekly over a period of 3 weeks
Secondary	Change in mineral and bone metabolism markers		Weekly over a period of 3 weeks
Secondary	Change in myokines		Weekly over a period of 3 weeks
Secondary	Change in cardiac remodeling markers		Weekly over a period of 3 weeks