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Chronic Kidney Disease Stage 3BPIONEERNCT04330807

Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease

A study testing Handgrip fatigability test and Questionnaires in people with Chronic Kidney Disease Stage 3B and Chronic Kidney Disease stage4, run by Centre Hospitalier le Mans at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Chronic Kidney Disease (CKD) induces many metabolic troubles especially for the advanced CKD (stage 3b-5) patients and their prevalence and importance grow with the deterioration of the glomerular filtration rate (GFR). Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Handgrip fatigability test and Questionnaires
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
1 siteFrance
Study dates
22 Jun 2020to 20 Dec 2021
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults, aged 60 and over
  • Social security coverage
  • Signed informed consent
  • For patient with Chronic Kidney Disease, estimated glomerular filtration rate (eGFR) less than 45ml/min/1.73m2 (Stage 3b) for at least 3 months
  • For patient with Chronic Kidney Disease, stable clinical condition (i.e., Creatinine increased by a maximum of 25% in the previous 3 months)
  • For control group, 1:1 recruitment with case matching with CDK patients on gender (i.e., male and female) and the presence of diabètes (i.e., presence and absence)
  • For control group, blood test with control of renal function available and dated less than 6 months: with eGFR > 60ml/min/1.73m2 (and control of glucose or glycated hemoglobin for diabetic controls)

Who cannot join

  • Pregnant women
  • Under guardianship or minor
  • Neuromuscular disease
  • Dementia
  • Upper limbs history of surgery or pathologies preventing from fitting EMG electrodes or measuring handgrip force
  • Life expectancy of less than 3 months estimated by medical judgment
Show all 10Show fewer
  • Programed hospitalization in the previous 3 months
  • Participation to another interventional clinical trial
  • Acute kidney disease
  • On dialysis or expected start of dialysis within next 3 months

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier Du Mans

    Le Mans, 72000

Other trials in France

About this study

Chronic Kidney Disease (CKD) induces many metabolic troubles especially for the advanced CKD (stage 3b-5) patients and their prevalence and importance grow with the deterioration of the glomerular filtration rate (GFR). Among them, muscle wasting is common and multifactorial, partially explained by an imbalance between protein catabolism and synthesis. Muscular strength is also affected beyond the reduction of the lean body mass, resulting in profound fatigue.

The present study seeks to quantify the prevalence of low muscular strength production (dynapenia) in a cohort of elderly patients with advanced CKD, through a maximal voluntary contraction (MVC) handgrip test compared to control data available in the literature, matched in term of age and sex. It also aims to investigate the link between the reported fatigue (subjective) and the evolution of the MVC, called critical force (fcrit) during a fatiguing task (objective fatigability).

Being tested
Handgrip fatigability test, Questionnaires
Keywords
Neuromuscular abilities, Dynapenia, Over-60-year-old patients
Medical subject headings
Renal Insufficiency, Chronic, Fatigue

What participants receive

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

  • Handgrip fatigability testOther

    Dynamometric and electromyographic assessment: patient is sitting on a chair, back upright, humerus vertically placed and forearm landing parallel to a support. Dominant arm is chosen for test and electrodes placement.

    The assessment is divided in 4 phases for a total of 30 minutes duration: Warm-up, determination of reference force settings (fast sub-maximal contractions and maximal voluntary contractions), fatigability period and rest.

  • QuestionnairesOther

    Assessment of subjective fatigue with Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Multidimensional Fatigue Inventory (MFI-20) questionnaires

Study groups in NCT04330807
Study groupRoleWhat they receive
Patient with chronic kidney diseaseOtherPatients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue.
Receives: Other: Handgrip fatigability test; Other: Questionnaires
CONTROL GROUPOtherPatients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue.
Receives: Other: Handgrip fatigability test; Other: Questionnaires

What is being measured

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

  1. DYNAPENIA

    The main outcome of the study is to defined the prevalence of dynapenia for advanced CKD elderly patients. Dynapenia will be established when the mean of the first three MVC of the protocol is lower compared to the reference values appaired for age and sex. For reference values of elderly, please see Ramírez-Vélez et al., (2019).

    Measured: 1 day

Secondary outcomes (3)

  1. EMG signal

    To analyze the amplitude of the EMG signal recorded, it will be rectified with the Root Mean Square (RMS) method. Frequency analysis will be performed with the Fast Fourier Transform (FFT).

    Measured: 1 day

  2. Objective fatigue

    The nmF is an indicator of the objective fatigue, it is identified by measuring the Fcrit during the fatigability period of the protocol (Figure 1). The value of Fcrit is the asymptote of the MVC curve plotted. This value is calculated for each individual.

    Measured: 1 day

  3. Subjective fatigue

    The symptom of fatigue will be assessed with two questionnaires, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the Multidimensional Fatigue Inventory (MFI-20). FACIT-F is a validated questionnaire in French language (Kwakkenbos et al., 2014), slightly short, including 13 pragmatically and simple affirmations (e.g., I am too tired to eat) with Likert scale (0: "Not at all" to 4: "enormously"). The questionnaire depicted 4 dimensions (i.e., General fatigue, mental fatigue, reduced activities, motivation) and the final score ranges from 0 to 52, with an elevated score depicted a low fatigue. MFI-20 is a validated questionnaire in French language (Gentile et al., 2003) focused about fatigue. It is built with a balance between positive trend questions (e.g., Physically I feel I am in an excellent condition) and negative trend question (e.g., Physically I feel only able to do a little). An elevated score depicted a higher fatigue.

    Measured: 1 day

Timeline

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

  1. First posted2 Apr 2020
  2. Study start22 Jun 2020
  3. Primary completion20 Dec 2021
  4. Study completion20 Dec 2021

Why it stopped: The effect size from the a priori sample size calculation (220 participants) had been underestimated. Based on the results, the effect size was larger and allowed for greater statistical power than that estimated with 161 participants.

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04330807
Sponsor's protocol ID
CHM-2020/S8/01
Acronym
PIONEER
Status last verified
Jun 2026
First submitted
26 Mar 2020
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chatrenet A, Beaune B, Fois A, Pouliquen C, Audebrand JM, Torreggiani M, Paris D, Durand S, Piccoli GB. PhysIOpathology of NEuromuscular function rElated to fatigue in chronic Renal disease in the elderly (PIONEER): study protocol. BMC Nephrol. 2020 Jul 25;21(1):305. doi: 10.1186/s12882-020-01976-6.

    PubMed 32711479

Questions about this trial

What is this clinical trial studying?

A study testing Handgrip fatigability test and Questionnaires in people with Chronic Kidney Disease Stage 3B and Chronic Kidney Disease stage4, run by Centre Hospitalier le Mans at 1 site 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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was stopped early (reason given: The effect size from the a priori sample size calculation (220 participants) had been underestimated. Based on the results, the effect size was larger and allowed for greater statistical power than that estimated with 161 participants.). Results are not available in the source record.

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?

DYNAPENIA (time frame: 1 day). 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 NCT04330807, 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 1 Jul 2026.

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