Clinical trial NCT03998917: Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.
Official title: Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
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
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
Collaborators: name: Le Mans Universite
First posted: 2019-06-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Neuromuscular evaluation of force.
timeFrame: 1 day
Secondary outcomes:
measure: Psychometric evaluation of fatigue
timeFrame: 1 day
measure: Quality of life impact of fatigue
timeFrame: 1 day
measure: Assessment of gait and balance
timeFrame: 1 day
measure: Assesment of lower limb functional strength
timeFrame: 1 day
measure: Assesment of walking speed
timeFrame: 1 day
measure: Electromyographic evaluation: temporal recruitment of the motor units.
timeFrame: 1 day
measure: Electromyographic evaluation: Root Mean Square measurement
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Le Mans, Nephrology Department
name: Giorgina Piccoli, MD
role: PRINCIPAL_INVESTIGATOR
References: