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.
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
- Conditions the study is for
- Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5
- 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
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
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- 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.
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).
- Conditions
- Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Fatigue
- 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 group | Role | What they receive |
|---|---|---|
| Patient with chronic kidney disease | Other | Patients 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 GROUP | Other | Patients 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.
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)
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
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
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.
- First posted2 Apr 2020
- Study start22 Jun 2020
- Primary completion20 Dec 2021
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Stage 3BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Collaborators
- Le Mans Universite
- Responsible party
- Sponsor
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