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The effect size from the a priori sample size calculation (220 participants) had been underestimated. Based on the results, the effect size was larger and allowed for greater statistical power than that estimated with 161 participants.
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| Name | Class |
|---|---|
| Le Mans Universite | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with chronic kidney disease | Other | Patients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue. |
|
| CONTROL GROUP | Other | Patients will perform a Handgrip fatigability test with their dominant hand and will complete two questionnaires of assessment of subjective fatigue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Handgrip fatigability test | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 RamÃrez-Vélez et al., (2019). | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Objective fatigue |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Clinical data |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Du Mans | Le Mans | 72000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32711479 | Derived | 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. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| Questionnaires | Other | Assessment of subjective fatigue with Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Multidimensional Fatigue Inventory (MFI-20) questionnaires |
|
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 |
| 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 |
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. |
| 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. |
| 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |