Clinical trial NCT04330807: Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease
Official title: Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease Stage 3B
Chronic Kidney Disease stage4
Chronic Kidney Disease Stage 5
Fatigue
Keywords: Neuromuscular abilities
Dynapenia
Over-60-year-old patients
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
Collaborators: name: Le Mans Universite
First posted: 2020-04-02
Enrollment: 220
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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). 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).


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: DYNAPENIA
timeFrame: 1 day
Secondary outcomes:
measure: EMG signal
timeFrame: 1 day
measure: Objective fatigue
timeFrame: 1 day
measure: Subjective fatigue
timeFrame: 1 day
Other outcomes:
measure: Anthropometric data
timeFrame: Within 3 months for the CKD patients, within 6 months for the control volunteers.
measure: Clinical data
timeFrame: Within 3 months for the CKD patients, within 6 months for the control volunteers.
measure: Nutritional data
timeFrame: Within 3 months for the CKD patients, within 6 months for the control volunteers.
measure: Biochemical data
timeFrame: Within 3 months for the CKD patients, within 6 months for the control volunteers.
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans
Study officials:
References:
citation: 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.