Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease
NCT ID: NCT04330807
Last Updated: 2022-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
220 participants
INTERVENTIONAL
2020-06-22
2022-06-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Patient with chronic kidney disease
Patients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue.
Handgrip fatigability test
Dynamometric and electromyographic assessment: patient is sitting on a chair, back upright, humerus vertically placed and forearm landing parallel to a support. Dominant arm is chosen for test and electrodes placement.
The assessment is divided in 4 phases for a total of 30 minutes duration: Warm-up, determination of reference force settings (fast sub-maximal contractions and maximal voluntary contractions), fatigability period and rest.
Questionnaires
Assessment of subjective fatigue with Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Multidimensional Fatigue Inventory (MFI-20) questionnaires
CONTROL GROUP
Patients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue.
Handgrip fatigability test
Dynamometric and electromyographic assessment: patient is sitting on a chair, back upright, humerus vertically placed and forearm landing parallel to a support. Dominant arm is chosen for test and electrodes placement.
The assessment is divided in 4 phases for a total of 30 minutes duration: Warm-up, determination of reference force settings (fast sub-maximal contractions and maximal voluntary contractions), fatigability period and rest.
Questionnaires
Assessment of subjective fatigue with Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Multidimensional Fatigue Inventory (MFI-20) questionnaires
Interventions
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Handgrip fatigability test
Dynamometric and electromyographic assessment: patient is sitting on a chair, back upright, humerus vertically placed and forearm landing parallel to a support. Dominant arm is chosen for test and electrodes placement.
The assessment is divided in 4 phases for a total of 30 minutes duration: Warm-up, determination of reference force settings (fast sub-maximal contractions and maximal voluntary contractions), fatigability period and rest.
Questionnaires
Assessment of subjective fatigue with Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Multidimensional Fatigue Inventory (MFI-20) questionnaires
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
Yes
Sponsors
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Le Mans Universite
OTHER
Centre Hospitalier le Mans
OTHER
Responsible Party
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Locations
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Centre Hospitalier Du Mans
Le Mans, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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CHM-2020/S8/01
Identifier Type: -
Identifier Source: org_study_id
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