Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease (PIONEER)

Centre Hospitalier le Mans

Status: Unknown

Conditions: Chronic Kidney Disease stage4; Chronic Kidney Disease Stage 3B; Fatigue; Chronic Kidney Disease Stage 5

Treatments: Other: Handgrip fatigability test; Other: Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT04330807

CHM-2020/S8/01

Details and patient eligibility

About

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).

Enrollment: 220 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Patient with chronic kidney disease

Other group

Description:

Patients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue.

Treatment:

Other: Handgrip fatigability test

Other: Questionnaires

CONTROL GROUP

Other group

Description:

Patients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue.

Treatment:

Other: Handgrip fatigability test

Other: Questionnaires