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

Primary Purpose

Chronic Kidney Diseases

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Dialysis without physical exercise

Dialysis with pre-dialytic physical exercise

Dialysis with per-dialytic physical exercise

About this trial

This is an interventional other trial for Chronic Kidney Diseases focused on measuring Chronic kidney disease on dialysis, Physical exercise, Regional myocardial function, Myocardial stunning

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Lapeyronie Hospital clinical trials Department
AIDER SantéRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients issued from dialysis units (clinic)

Arm Description

Outcomes

Primary Outcome Measures

Change in regional myocardial function and myocardial stunning

Secondary Outcome Measures

Change in blood viscosity

Change in arterial stiffness

Change in sinus rhythm

Change in dialysis efficacy

Change in inflammatory markers

Change in mineral and bone metabolism markers

Change in myokines

Change in cardiac remodeling markers

Full Information

NCT ID

NCT04831021

First Posted

April 1, 2021

Last Updated

December 31, 2021

Sponsor

University Hospital, Montpellier

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04831021

Brief Title

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

Acronym

EXP DIAL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 24, 2021 (Actual)

Primary Completion Date

October 2022 (Anticipated)

Study Completion Date

April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Diseases

Keywords

Chronic kidney disease on dialysis, Physical exercise, Regional myocardial function, Myocardial stunning

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients issued from dialysis units (clinic)

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Dialysis without physical exercise

Intervention Description

Hemodialysis control condition

Intervention Type

Procedure

Intervention Name(s)

Dialysis with pre-dialytic physical exercise

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Dialysis with per-dialytic physical exercise

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in regional myocardial function and myocardial stunning

Time Frame