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

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ClinicalTrials.gov Identifier: NCT04330807
Recruitment Status : Not yet recruiting
First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Sponsor:
Collaborator:
Le Mans Universite
Information provided by (Responsible Party):
Centre Hospitalier le Mans

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).


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Stage 3B Chronic Kidney Disease stage4 Chronic Kidney Disease Stage 5 Fatigue Other: Handgrip fatigability test Other: Questionnaires Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: 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.


Other: 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.
Other: 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.


Other: Questionnaires
Assessment of subjective fatigue with Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Multidimensional Fatigue Inventory (MFI-20) questionnaires




Primary Outcome Measures :
  1. DYNAPENIA [ Time Frame: 1 day ]
    The main outcome of the study is to defined the prevalence of dynapenia for advanced CKD elderly patients. Dynapenia will be established when the mean of the first three MVC of the protocol is lower compared to the reference values appaired for age and sex. For reference values of elderly, please see Ramírez-Vélez et al., (2019).


Secondary Outcome Measures :
  1. EMG signal [ Time Frame: 1 day ]
    To analyze the amplitude of the EMG signal recorded, it will be rectified with the Root Mean Square (RMS) method. Frequency analysis will be performed with the Fast Fourier Transform (FFT).

  2. Objective fatigue [ Time Frame: 1 day ]
    The nmF is an indicator of the objective fatigue, it is identified by measuring the Fcrit during the fatigability period of the protocol (Figure 1). The value of Fcrit is the asymptote of the MVC curve plotted. This value is calculated for each individual.

  3. Subjective fatigue [ Time Frame: 1 day ]
    The symptom of fatigue will be assessed with two questionnaires, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the Multidimensional Fatigue Inventory (MFI-20). FACIT-F is a validated questionnaire in French language (Kwakkenbos et al., 2014), slightly short, including 13 pragmatically and simple affirmations (e.g., I am too tired to eat) with Likert scale (0: "Not at all" to 4: "enormously"). The questionnaire depicted 4 dimensions (i.e., General fatigue, mental fatigue, reduced activities, motivation) and the final score ranges from 0 to 52, with an elevated score depicted a low fatigue. MFI-20 is a validated questionnaire in French language (Gentile et al., 2003) focused about fatigue. It is built with a balance between positive trend questions (e.g., Physically I feel I am in an excellent condition) and negative trend question (e.g., Physically I feel only able to do a little). An elevated score depicted a higher fatigue.


Other Outcome Measures:
  1. Anthropometric data [ Time Frame: Within 3 months for the CKD patients, within 6 months for the control volunteers. ]
    Only relevant data will be collected from medical folder such as age, sex... to determine anthropometric data.

  2. Clinical data [ Time Frame: Within 3 months for the CKD patients, within 6 months for the control volunteers. ]
    Relevant data will be collected from medical folder such as existence of a diabetes, type of kidney disease, time of follow-up, Charlson Comorbidity Index (CCI ; Charlson et al., 1987) and Malnutrition Inflammation Score (Borges et al., 2017) to determine comorbidities data.

  3. Nutritional data [ Time Frame: Within 3 months for the CKD patients, within 6 months for the control volunteers. ]
    Relevant data will be collected from medical folder such as Malnutrition Inflammation Score (Borges et al., 2017), Subjective global assessment, albumin, total cholesterol, HDL, LDL, triglycerides, uric acid, blood formula count, creatinine, urea, glycemia, 24 hours proteinuria, pre-albumine, uric acid to determine nutritional status.

  4. Biochemical data [ Time Frame: Within 3 months for the CKD patients, within 6 months for the control volunteers. ]
    Relevant data will be collected from medical folder such as calcium, phosphorus, PTH, vitamin D, bicarbonate, sodium and potassium to define biochemical data.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04330807


Contacts
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Contact: Christelle JADEAU 0033 2 43 43 43 43 ext 37482 cjadeau@ch-lemans.fr
Contact: Giorgina PICCOLI, MD 0033 2 43 43 43 43 ext 37138 gpiccoli@ch-lemans.fr

Sponsors and Collaborators
Centre Hospitalier le Mans
Le Mans Universite
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier le Mans
ClinicalTrials.gov Identifier: NCT04330807    
Other Study ID Numbers: CHM-2020/S8/01
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier le Mans:
Neuromuscular abilities
Dynapenia
Over-60-year-old patients
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Fatigue
Urologic Diseases
Renal Insufficiency