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Chronic Renal FailureEX-CHRODIALNCT04697459

Chronic Intradialytic Exercise : a Cardioprotective Role

A study testing chronic phase and acute phase in people with Chronic Renal Failure, run by University of Avignon at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function. Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Chronic Renal Failure
What is being tested?
chronic phase and acute phase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
2 sitesFrance
Study dates
13 Dec 2020to 30 Sep 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

  • No medical contraindication to physical activity
  • Life expectancy greater than 6 months
  • Patients on haemodialysis for more than 3 months

Who cannot join

  • Pregnancy
  • Valvular heart disease,
  • Unstable coronary artery disease
  • Arteriopathy obliterating of the lower limbs stage III and IV
  • Musculoskeletal problems
  • Severe respiratory disease
Show all 11Show fewer
  • BMI> 35
  • Pacemaker, cardiac stimulation and automatic implantable defibrillator
  • Heart transplant
  • Uncontrolled arterial hypertension
  • Ejection fraction <45%

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • ATIR

    Avignon, Vaucluse, 84000

  • Centre Hemodialyse AIDER sante

    Nîmes, Gard, 30029

Other trials in France

About this study

Official title: Chronic Intradialytic Exercise: a Cardioprotective Role

The main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function.

Read the detailed description

Background: Hemodialysis patients have a mortality rate 50 times higher than in the general population, and the cause remains cardiovascular in more than half of the cases. A deleterious morphological and functional cardiac remodelling is well established in these patients, the causes of which are both the presence of factors specific to renal disease (hemodynamic and non-hemodynamic) and co-morbidities (diabetes, hypertension, etc. .) but also to the hemodialysis (HD) procedure itself, due to the sudden hemodynamic changes it imposes, leading to repeated episodes of intradialytic hypotension (HID) and myocardial stunning. The latter are now documented as direct contributors to the increased mortality observed in HD patients compared to the general population. The introduction of intradialytic physical exercise in the therapeutic program of HD patient is now recommended and practised routinely in many countries, in Scandinavia in particular. Several meta-analyses have clearly established its safety. The beneficial role of chronic intradialytic exercise in improving dialysis efficiency, mental health and quality of life, as well as the inflammatory status of HD patients is also clearly demonstrated. Chronic intradialytic exercise is also associated with improvements in overall fitness level, a parameter closely linked to cardiovascular mortality. Applied acutely during dialysis, it could play a cardioprotective role (e.g; limiting myocardial stunning), allowing haemodynamic and cardiac functional stabilization during HD. However, to our knowledge, no study to date has investigated the long-term effects of intradialytic exercise on remodelling and overall and regional heart function.

Aims: The main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function. The secondary objectives are to evaluate the effect of acute intradialytic exercise on myocardial stunning as well as the effect of chronic physical exercise on macro and microcirculatory vascular function, inflammation, physical fitness and health-related quality of life.

Being tested
chronic phase, acute phase
Keywords
exercise, hemodialysis
Medical subject headings
Kidney Failure, Chronic, Motor Activity

What participants receive

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

  • chronic phaseOther

    1h of intradialytic execise, starting 30 min after hemodialysis beginning : 30 min of low-intensity (Borg Scale 11-14) aerobic exercise + 30 min of resistance training, frequency : 3 times a week for 16 weeks.

  • acute phaseOther

    30 min of low-intensity (Borg Scale 11-14) aerobic exercise, starting 30 min after hemodialysis beginning

Study groups in NCT04697459
Study groupRoleWhat they receive
HD-EX (patient with intradialytic exercise)Experimentalwill be enrolled in a 16 week intradilatytic exercise program.
Receives: Other: chronic phase; Other: acute phase
HD (patients with standard HD)No interventionpatients with standard hemodialysis (e.g. without exercise).

What is being measured

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

  1. Changes in myocardial longitudinal deformations

    Myocardial longitudinal linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.

    Measured: Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.

  2. Changes in myocardial longitudinal deformations

    Myocardial longitudinal linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.

    Measured: Chronic phase : before (week 0) and after (week 17) an exercise training program of 16 weeks; each time in the same conditions as in acute phase (e.g. just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise).

  3. Changes in myocardial circumferential deformations

    Myocardial circumferential linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.

    Measured: Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.

  4. Changes in myocardial circumferential deformations

    Myocardial circumferential linear deformations (in percent) will be assessed by high-resolution echocardiography in deformation imaging mode.

    Measured: Chronic phase : before (week 0) and after (week 17) an exercise training program of 16 weeks; each time in the same conditions as in acute phase (e.g. just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise).

  5. Changes in left ventricular torsion

    Left ventricular torsion (in degree) will be assessed by high-resolution echocardiography in deformation imaging mode.

    Measured: Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.

  6. Changes in left ventricular torsion

    Left ventricular torsion (in degree) will be assessed by high-resolution echocardiography in deformation imaging mode.

    Measured: Chronic phase : before (week 0) and after (week 17) an exercise training program of 16 weeks; each time in the same conditions as in acute phase (e.g. just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise).

Secondary outcomes (4)

  1. Changes in arterial rigidity

    Measurement of pulse wave velocity (m/s) by photo-plethysmography at rest before dialysis.

    Measured: before (week 0) and after (week 17) an exercise training program of 16 weeks

  2. Changes in Physical fitness

    The six-minute walking test (meters); maximal isometric force (newtons) during a knee-extension test and handgrip test using a dynamometer.

    Measured: before (week 0) and after (week 17) an exercise training program of 16 weeks

  3. Health-related Quality of life

    The 36-Item Short Form Health Survey questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

    Measured: before (week 0) and after (week 17) an exercise training program of 16 weeks

  4. Changes in carotid intimal-media wall thickness

    The intimal plus media wall thickness (mm) of the right carotid artery will be measured using high-resolution echography.

    Measured: before (week 0) and after (week 17) an exercise training program of 16 weeks

Timeline

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

  1. First posted6 Jan 2021
  2. Study start13 Dec 2020
  3. Primary completion14 May 2023
  4. Study completion30 Sep 2023

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
* Acute phase : standard HD versus HD with acute intradialytic exercise (in HD-EX group only); * Chronic phase : before and after an exercise training program of 16 weeks (HD-EX group) as well as before and after 16 weeks of standard HD (HD group)
Masking
Single blind
Who is masked
Investigator
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04697459
Sponsor's protocol ID
2020-09-14
Acronym
EX-CHRODIAL
Status last verified
Nov 2023
First submitted
14 Dec 2020
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Josse M, Patrier L, Isnard M, Turc-Baron C, Grandperrin A, Nottin S, Mandigout S, Cristol JP, Maufrais C, Obert P. Cardioprotective Effect of Acute Intradialytic Exercise: A Comprehensive Speckle-Tracking Echocardiography Analysis. J Am Soc Nephrol. 2023 Aug 1;34(8):1445-1455. doi: 10.1681/ASN.0000000000000149. Epub 2023 Apr 18.

    PubMed 37071035

Questions about this trial

What is this clinical trial studying?

A study testing chronic phase and acute phase in people with Chronic Renal Failure, run by University of Avignon 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 29 Nov 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in myocardial longitudinal deformations (time frame: Acute phase : just before and 90 and 210 minutes within standard dialysis or dialysis including acute exercise.). The study lists 6 primary outcomes in all. 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 NCT04697459, 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 29 Nov 2023.

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