Chronic Kidney FailurePIONNIERNCT03998917
Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.
An observational study of Chronic Kidney Failure and Chronic Kidney Disease stage3, run by Centre Hospitalier le Mans at 1 site in France.
Trial summary
The evolution of chronic kidney disease (CKD) causes a systemic upheaval on the body and a deep fatigue is very often described by patients (50-70% of the patients) even before the start of dialysis (pre-dialysis). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Failure, Chronic Kidney Disease stage3, Chronic Kidney Disease, Stage 4 (Severe)
- What is being tested?
- Discrimination of neuromuscular alterations protocol
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2019to 31 Dec 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chronic Kidney Disease (CKD) group: Patients with chronic kidney disease and a glomerular filtration rate less than 60 ml/min of creatinine. Control group: The control group will consist of a group of people from the same age group as the CKD group but without chronic kidney disease. The exclusion criteria apply to this group. They will be selected from the spouses and other volunteers.
Who may be able to join
- Adult patients (Age> 18 years) who have signed the informed consent form
- Social security coverage
- For patients in the Chronic Kidney Disease group: Glomerular filtration rate less than 60 ml/min of creatinine for more than three months
Who cannot join
- Dermatological conditions of the upper limbs which would contra-indicate Electromyographic electrodes being positioned
- Gestating women
- Patients with known neuromuscular conditions
- Patients with dementia
- Patients with acute heart failure
- Patients with a history of surgery of the evaluated limb
- Patients included in an interventional study involving administration of treatments other than routine care
- For the patients in the Chronic Kidney Disease group: patients currently undergoing dialysis or in a pre-dialysis program (e.g. with a dialysis fistula already in place).
Trial locations and contacts
1 site in 1 country.
About this study
The evolution of chronic kidney disease (CKD) causes a systemic upheaval on the body and a deep fatigue is very often described by patients (50-70% of the patients) even before the start of dialysis (pre-dialysis). This fatigue has many origins, and one of them probably stems from a deterioration of neuromuscular abilities. Very few studies have examined the physiological aspects of neuromuscular fatigue in pre-dialysis patients, and shedding light on potential deficits at this level would allow safe and efficient implementation of adapted physical activity programs.
Our study aims to characterize the pathophysiology of neuromuscular capabilities in chronic advanced renal failure in pre-dialysis patients.
- Conditions
- Chronic Kidney Failure, Chronic Kidney Disease stage3, Chronic Kidney Disease, Stage 4 (Severe), Chronic Kidney Disease Stage 5, Fatigue
- Being tested
- Discrimination of neuromuscular alterations protocol
- Keywords
- Chronic Kidney Failure, Fatigue, Adapted Physical Activity
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discrimination of neuromuscular alterations protocolDiagnostic test
Patients will perform a hand grip fatigability test with their dominant hand, followed by a Timed Up and Go Test (TUG-Test), a Five-repetition sit-to-stand-test (5STS-Test) and a10 meters gait speed test.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Disease (CKD) Patients | Patients with chronic kidney disease and a glomerular filtration rate less than 60 ml/min of creatinine. Patients will perform a hand grip fatigability test with their dominant hand, followed by a Timed Up and Go Test (TUG-Test), a Five-repetition sit-to-stand-test (5STS-Test) and a10 meters gait speed test. Receives: Diagnostic Test: Discrimination of neuromuscular alterations protocol | |
| Control cohort | The control cohort will consist of a group of people from the same age group as the CKD group but without chronic kidney disease. The exclusion criteria apply to this group. They will be selected from the spouses and other volunteers. This group will also perform a hand grip fatigability test with their dominant hand, followed by a Timed Up and Go Test (TUG-Test), a Five-repetition sit-to-stand-test (5STS-Test) and a10 meters gait speed test. Receives: Diagnostic Test: Discrimination of neuromuscular alterations protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular evaluation of force.
Maximum force normalized by body mass, measured by a hand grip test with the dominant hand.
Measured: 1 day
Secondary outcomes (7)
Psychometric evaluation of fatigue
The Multidimensional Fatigue Inventory (MFI) is a 20 question self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each question is graded from 1 ("Yes, that is true") to 5 ("No, that is not true"). Higher scores indicate a higher level of fatigue.
Measured: 1 day
Quality of life impact of fatigue
The functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) evaluates the impact on quality of life of chronic illness.
This is a questionnaire with 13 questions graded according to a Likert scale ranging from 1 to 5 (1 = quite, 5 = not at all).
Measured: 1 day
Assessment of gait and balance
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: 1 day
Assesment of lower limb functional strength
The five-repetition sit-to-stand test (5STS) is a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded.
Measured: 1 day
Assesment of walking speed
10 meters gait speed test: measure of the time required to walk 10 meters at the fastest speed possible.
Measured: 1 day
Electromyographic evaluation: temporal recruitment of the motor units.
The evolution of temporal recruitment through the evaluation of the discharge frequency of the motor units.
Measured: 1 day
Electromyographic evaluation: Root Mean Square measurement
The average Root Mean Square (RMS) evolution according to the progress of the fatigability protocol, and its link with the developed force.
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 posted26 Jun 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Human subjects protection's soubmission denied
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Collaborators
- Le Mans Universite
- Responsible party
- Sponsor
- Investigators
- Giorgina Piccoli, MD, Principal investigator, Centre Hospitalier Le Mans, Nephrology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998917
- Sponsor's protocol ID
- CHM-2019/S8/02
- Acronym
- PIONNIER
- Status last verified
- Mar 2020
- First submitted
- 24 Jun 2019
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.
- ClinicalTrials.gov ID
- NCT03998917
- Acronym / sponsor ID
- PIONNIER / CHM-2019/S8/02
- Conditions
- Chronic Kidney Failure, Chronic Kidney Disease stage3, Chronic Kidney Disease, Stage 4 (Severe), Chronic Kidney Disease Stage 5, Fatigue
- Keywords
- Chronic Kidney Failure, Fatigue, Adapted Physical Activity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Human subjects protection's soubmission denied
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Collaborators
- Le Mans Universite
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The evolution of chronic kidney disease (CKD) causes a systemic upheaval on the body and a deep fatigue is very often described by patients (50-70% of the patients) even before the start of dialysis (pre-dialysis). This fatigue has many origins, and one of them probably stems from a deterioration of neuromuscular abilities. Very few studies have examined the physiological aspects of neuromuscular fatigue in pre-dialysis patients, and shedding light on potential deficits at this level would allow safe and efficient implementation of adapted physical activity programs.
Our study aims to characterize the pathophysiology of neuromuscular capabilities in chronic advanced renal failure in pre-dialysis patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease (CKD) Patients | – | Diagnostic Test: Discrimination of neuromuscular alterations protocolPatients with chronic kidney disease and a glomerular filtration rate less than 60 ml/min of creatinine. Patients will perform a hand grip fatigability test with their dominant hand, followed by a Timed Up and Go Test (TUG-Test), a Five-repetition sit-to-stand-test (5STS-Test) and a10 meters gait speed test. |
| Control cohort | – | Diagnostic Test: Discrimination of neuromuscular alterations protocolThe control cohort will consist of a group of people from the same age group as the CKD group but without chronic kidney disease. The exclusion criteria apply to this group. They will be selected from the spouses and other volunteers. This group will also perform a hand grip fatigability test with their dominant hand, followed by a Timed Up and Go Test (TUG-Test), a Five-repetition sit-to-stand-test (5STS-Test) and a10 meters gait speed test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Kidney Disease (CKD) group: Patients with chronic kidney disease and a glomerular filtration rate less than 60 ml/min of creatinine. Control group: The control group will consist of a group of people from the same age group as the CKD group but without chronic kidney disease. The exclusion criteria apply to this group. They will be selected from the spouses and other volunteers.
Key inclusion criteria (3 listed)
- Adult patients (Age> 18 years) who have signed the informed consent form
- Social security coverage
- For patients in the Chronic Kidney Disease group: Glomerular filtration rate less than 60 ml/min of creatinine for more than three months
Key exclusion criteria (8 listed)
- Dermatological conditions of the upper limbs which would contra-indicate Electromyographic electrodes being positioned
- Gestating women
- Patients with known neuromuscular conditions
- Patients with dementia
- Patients with acute heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discrimination of neuromuscular alterations protocolPatients will perform a hand grip fatigability test with their dominant hand, followed by a Timed Up and Go Test (TUG-Test), a Five-repetition sit-to-stand-test (5STS-Test) and a10 meters gait speed test. | Diagnostic test | Chronic Kidney Disease (CKD) Patients, Control cohort |
Primary outcome
Neuromuscular evaluation of force.
Time frame: 1 day
Maximum force normalized by body mass, measured by a hand grip test with the dominant hand.
7 secondary outcomes
Psychometric evaluation of fatigue
Time frame: 1 day
Quality of life impact of fatigue
Time frame: 1 day
Assessment of gait and balance
Time frame: 1 day
Assesment of lower limb functional strength
Time frame: 1 day
Assesment of walking speed
Time frame: 1 day
Electromyographic evaluation: temporal recruitment of the motor units.
Time frame: 1 day
Electromyographic evaluation: Root Mean Square measurement
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Failure
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Active, not recruitingPhase 4
A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
Chronic Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgina Piccoli, MD principal investigator
Centre Hospitalier Le Mans, Nephrology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Failure and Chronic Kidney Disease stage3, 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 3 inclusion and 8 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: withdrawn, 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 withdrawn before enrolling participants, so there are no results.
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?
Neuromuscular evaluation of force. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.