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Chronic Kidney DiseasesEXP DIALNCT04831021

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

A study testing Dialysis without physical exercise, Dialysis with pre-dialytic physical exercise and Dialysis with per-dialytic physical exercise in people with Chronic Kidney Diseases, run by University Hospital, Montpellier at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
Dialysis without physical exercise, Dialysis with pre-dialytic physical exercise and Dialysis with per-dialytic physical exercise
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesFrance
Study dates
24 Sep 2021to Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Jean Paul CRISTOL, MD, PhD contact

04 67 33 83 14

jp-cristol@chu-montpellier.fr

France2 sites, 2 recruiting

  • Lapeyronie Hospital clinical trials Department

    Montpellier, Hérault, 34295

    Jean Paul CRISTOL, MD, PhD, 04 67 33 83 14, jp-cristol@chu-montpellier.fr

    Not yet recruiting

  • AIDER Santé

    Montpellier

    Cécile TURC-BARON, MD

    Recruiting

Other trials in France

About this study

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.

Being tested
Dialysis without physical exercise, Dialysis with pre-dialytic physical exercise, Dialysis with per-dialytic physical exercise
Keywords
Chronic kidney disease on dialysis, Physical exercise, Regional myocardial function, Myocardial stunning
Medical subject headings
Renal Insufficiency, Chronic, Motor Activity, Myocardial Stunning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dialysis without physical exerciseProcedure or surgery

    Hemodialysis control condition

  • Dialysis with pre-dialytic physical exerciseProcedure or surgery

    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 exerciseProcedure or surgery

    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.

Study groups in NCT04831021
Study groupRoleWhat they receive
Patients issued from dialysis units (clinic)ExperimentalNot described
Receives: Procedure: Dialysis without physical exercise; Procedure: Dialysis with pre-dialytic physical exercise; Procedure: Dialysis with per-dialytic physical exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in regional myocardial function and myocardial stunning

    Measured: Weekly over a period of 3 weeks

Secondary outcomes (8)

  1. Change in blood viscosity

    Measured: Weekly over a period of 3 weeks

  2. Change in arterial stiffness

    Measured: Weekly over a period of 3 weeks

  3. Change in sinus rhythm

    Measured: Weekly over a period of 3 weeks

  4. Change in dialysis efficacy

    Measured: Weekly over a period of 3 weeks

  5. Change in inflammatory markers

    Measured: Weekly over a period of 3 weeks

  6. Change in mineral and bone metabolism markers

    Measured: Weekly over a period of 3 weeks

  7. Change in myokines

    Measured: Weekly over a period of 3 weeks

  8. Change in cardiac remodeling markers

    Measured: Weekly over a period of 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2021
  2. Study start24 Sep 2021
  3. Primary completionOct 2022 (estimated)
  4. Study completionApr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04831021
Sponsor's protocol ID
RECHMPL20_0462
Acronym
EXP DIAL
Status last verified
Dec 2021
First submitted
1 Apr 2021
Last updated
4 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Josse M, Turc-Baron C, Patrier L, Connes P, Grandperrin A, Nottin S, Cristol JP, Hedon C, Roubille F, Maufrais C, Obert P. Acute Exercise before Dialysis Is as Cardioprotective as during Dialysis: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2025 Aug 12;20(9):1236-1246. doi: 10.2215/CJN.0000000767.

    PubMed 40794519

Questions about this trial

What is this clinical trial studying?

A study testing Dialysis without physical exercise, Dialysis with pre-dialytic physical exercise and Dialysis with per-dialytic physical exercise in people with Chronic Kidney Diseases, run by University Hospital, Montpellier at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jean Paul CRISTOL, MD, PhD (04 67 33 83 14, jp-cristol@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in regional myocardial function and myocardial stunning (time frame: Weekly over a period of 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04831021, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.

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