Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease

Fatigue Clinical Trial

— PIONEER  

Official title:

Physiopathology of Neuromuscular Function Related to Fatigue in Chronic Renal Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04330807
• Other study ID #: CHM-2020/S8/01
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2020
• Est. completion date: June 2022

Study information

• Verified date: March 2022
• Source: Centre Hospitalier le Mans
• Contact: Christelle JADEAU
• Phone: 0033 2 43 43 43 43
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 3B
• Chronic Kidney Disease Stage 5
• Chronic Kidney Disease stage4
• Fatigue
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Du Mans	Le Mans

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans	Le Mans Universite

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropometric data	Only relevant data will be collected from medical folder such as age, sex... to determine anthropometric data.	Within 3 months for the CKD patients, within 6 months for the control volunteers.
Other	Clinical data	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.	Within 3 months for the CKD patients, within 6 months for the control volunteers.
Other	Nutritional data	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.	Within 3 months for the CKD patients, within 6 months for the control volunteers.
Other	Biochemical data	Relevant data will be collected from medical folder such as calcium, phosphorus, PTH, vitamin D, bicarbonate, sodium and potassium to define biochemical data.	Within 3 months for the CKD patients, within 6 months for the control volunteers.
Primary	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).	1 day
Secondary	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).	1 day
Secondary	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.	1 day
Secondary	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.	1 day