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

Primary Purpose

Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Handgrip fatigability test
Questionnaires
Sponsored by
Centre Hospitalier le Mans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Disease Stage 3B focused on measuring Neuromuscular abilities, Dynapenia, Over-60-year-old patients

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Centre Hospitalier Du MansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patient with chronic kidney disease

CONTROL GROUP

Arm Description

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

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

Outcomes

Primary Outcome Measures

DYNAPENIA
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

EMG signal
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).
Objective fatigue
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.
Subjective fatigue
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.

Full Information

First Posted
March 26, 2020
Last Updated
March 8, 2022
Sponsor
Centre Hospitalier le Mans
Collaborators
Le Mans Universite
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1. Study Identification

Unique Protocol Identification Number
NCT04330807
Brief Title
Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease
Acronym
PIONEER
Official Title
Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier le Mans
Collaborators
Le Mans Universite

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Fatigue
Keywords
Neuromuscular abilities, Dynapenia, Over-60-year-old patients

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with chronic kidney disease
Arm Type
Other
Arm Description
Patients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue.
Arm Title
CONTROL GROUP
Arm Type
Other
Arm Description
Patients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue.
Intervention Type
Other
Intervention Name(s)
Handgrip fatigability test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Assessment of subjective fatigue with Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Multidimensional Fatigue Inventory (MFI-20) questionnaires
Primary Outcome Measure Information:
Title
DYNAPENIA
Description
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).
Time Frame
1 day
Secondary Outcome Measure Information:
Title
EMG signal
Description
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).
Time Frame
1 day
Title
Objective fatigue
Description
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.
Time Frame
1 day
Title
Subjective fatigue
Description
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.
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
Anthropometric data
Description
Only relevant data will be collected from medical folder such as age, sex... to determine anthropometric data.
Time Frame
Within 3 months for the CKD patients, within 6 months for the control volunteers.
Title
Clinical data
Description
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.
Time Frame
Within 3 months for the CKD patients, within 6 months for the control volunteers.
Title
Nutritional data
Description
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.
Time Frame
Within 3 months for the CKD patients, within 6 months for the control volunteers.
Title
Biochemical data
Description
Relevant data will be collected from medical folder such as calcium, phosphorus, PTH, vitamin D, bicarbonate, sodium and potassium to define biochemical data.
Time Frame
Within 3 months for the CKD patients, within 6 months for the control volunteers.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle JADEAU
Phone
0033 2 43 43 43 43
Ext
37482
Email
cjadeau@ch-lemans.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Giorgina PICCOLI, MD
Phone
0033 2 43 43 43 43
Ext
37138
Email
gpiccoli@ch-lemans.fr
Facility Information:
Facility Name
Centre Hospitalier Du Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle JADEAU
Phone
+33244710781
Email
cjadeau@ch-lemans.fr
First Name & Middle Initial & Last Name & Degree
Giorgina PICCOLI, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32711479
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.
Results Reference
derived

Learn more about this trial

Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease

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