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Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.

Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03998917
Acronym
PIONNIER
Enrollment
0
Registered
2019-06-26
Start date
2019-09-01
Completion date
2020-12-31
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease stage3, Chronic Kidney Disease, Stage 4 (Severe), Chronic Kidney Disease Stage 5, Chronic Kidney Failure, Fatigue

Keywords

Chronic Kidney Failure, Fatigue, Adapted Physical Activity

Brief 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). 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.

Interventions

DIAGNOSTIC_TESTDiscrimination of neuromuscular alterations protocol

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.

Sponsors

Centre Hospitalier le Mans
Lead SponsorOTHER
Le Mans Universite
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Neuromuscular evaluation of force.1 dayMaximum force normalized by body mass, measured by a hand grip test with the dominant hand.

Secondary

MeasureTime frameDescription
Psychometric evaluation of fatigue1 dayThe 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.
Quality of life impact of fatigue1 dayThe 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).
Assessment of gait and balance1 dayThe 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.
Assesment of lower limb functional strength1 dayThe 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.
Assesment of walking speed1 day10 meters gait speed test: measure of the time required to walk 10 meters at the fastest speed possible.
Electromyographic evaluation: temporal recruitment of the motor units.1 dayThe evolution of temporal recruitment through the evaluation of the discharge frequency of the motor units.
Electromyographic evaluation: Root Mean Square measurement1 dayThe average Root Mean Square (RMS) evolution according to the progress of the fatigability protocol, and its link with the developed force.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGiorgina Piccoli, MD

Centre Hospitalier Le Mans, Nephrology Department

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026