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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04831021
Acronym
EXP DIAL
Enrollment
32
Registered
2021-04-05
Start date
2021-09-24
Completion date
2023-04-30
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

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

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.

Interventions

PROCEDUREDialysis without physical exercise

Hemodialysis control condition

PROCEDUREDialysis 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.

PROCEDUREDialysis 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.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in regional myocardial function and myocardial stunningWeekly over a period of 3 weeks

Secondary

MeasureTime frame
Change in arterial stiffnessWeekly over a period of 3 weeks
Change in sinus rhythmWeekly over a period of 3 weeks
Change in dialysis efficacyWeekly over a period of 3 weeks
Change in blood viscosityWeekly over a period of 3 weeks
Change in mineral and bone metabolism markersWeekly over a period of 3 weeks
Change in myokinesWeekly over a period of 3 weeks
Change in cardiac remodeling markersWeekly over a period of 3 weeks
Change in inflammatory markersWeekly over a period of 3 weeks

Countries

France

Contacts

Primary ContactJean Paul CRISTOL, MD, PhD
jp-cristol@chu-montpellier.fr04 67 33 83 14

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026