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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Recruiting

CT.gov ID

NCT04831021

Collaborator

AIDER- Santé (Other), Avignon University (EA4278 - LaPEC) (Other), Pr Philippe OBERT (Other), Dr Claire MAUFRAIS (Other)

Enrollment

Locations

Arm

18.2

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases	Procedure: Dialysis without physical exercise Procedure: Dialysis with pre-dialytic physical exercise Procedure: Dialysis with per-dialytic physical exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 24, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients issued from dialysis units (clinic)	Procedure: Dialysis without physical exercise Hemodialysis control condition Procedure: 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. Procedure: 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.

Arm

Intervention/Treatment

Experimental: Patients issued from dialysis units (clinic)

Procedure: Dialysis without physical exercise

Hemodialysis control condition

Procedure: 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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Change in regional myocardial function and myocardial stunning [Weekly over a period of 3 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 79 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lapeyronie Hospital clinical trials Department	Montpellier	Hérault	France	34295
2	AIDER Santé	Montpellier		France

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jean Paul CRISTOL, MD, PhD, CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
Study Chair: François ROUBILLE, MD, PhD, CHU ADV, Department of Cardiology, Montpellier, FRANCE
Study Chair: Cécile TURC-BARON, MD, AIDER Santé, Montpellier, FRANCE
Study Chair: Jérôme ADDA, MD, CHU ADV, Department of Cardiology, Montpellier, FRANCE