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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00982-37 | Other Identifier | ANSM |
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under-inclusion
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| Name | Class |
|---|---|
| University of Saint-Etienne | UNKNOWN |
| Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques | OTHER |
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Chronic fatigue is the most common and debilitating symptom in intensive care unit (ICU) survivors. Indeed, it has been widely reported that patients who stayed in ICU for prolonged periods report a feeling of tiredness for months to years after ICU discharge. This symptom seems particularly pronounced in Covid-19 patients and may affect their quality of life by decreasing their capacity to perform simple tasks of daily life.
The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in the feeling of fatigue of Covid-19 patients. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology and its recovery will allow to optimize rehabilitation treatments to shorten the persistence of chronic fatigue and in fine improve life quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Non-fatigued" patients who have been in intensive care units | Experimental |
| |
| "Fatigued" patients who have been in intensive care units | Experimental |
| |
| patients who have not been in intensive care units | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | Quality of life Depression Physical pain Social provisions Quality of sleep |
|
| Measure | Description | Time Frame |
|---|---|---|
| voluntary maximum force reduction | 6 weeks post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Neuromuscular function : cortical activity | Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation | 6 weeks post-discharge |
| Neuromuscular function : Peripheral function |
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Inclusion Criteria for patients who have been in intensive care :
Inclusion Criteria for patients who have NOT been in intensive care :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jérome MOREL, MD PhD | CHU de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Grenoble | Grenoble | France | ||||
| Clinique de la Sauvegarde - Lyon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38742855 | Derived | Kennouche D, Foschia C, Brownstein CG, Lapole T, Rimaud D, Royer N, LE Mat F, Thiery G, Gauthier V, Giraux P, Oujamaa L, Sorg M, Verges S, Doutreleau S, Marillier M, Prudent M, Bitker L, Feasson L, Gergele L, Stauffer E, Guichon C, Gondin J, Morel J, Millet GY. Factors Associated with Fatigue in COVID-19 ICU Survivors. Med Sci Sports Exerc. 2024 Sep 1;56(9):1563-1573. doi: 10.1249/MSS.0000000000003455. Epub 2024 Apr 14. |
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| blood test | Biological | complete blood count and cytokine concentration, TNF-alpha, LDL oxidized, AOPP, SOD, GPX, catalase, albumin, transthyretin, RBP, transferin, α-1 glycoprotein acide, ferritine, selenium, zinc, magnesium |
|
| Maximal effort test | Other | The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory. |
|
| actigraphy | Device | assessment of sleep quality |
|
| Neuromuscular evaluation | Device |
|
|
| stool analysis | Other | analyze the composition of the intestinal microbiote. concerns only the patients of Saint Etienne |
|
| food diary | Other | 3 days of information to determine nutrient intakes. concerns only the patients of Saint Etienne |
|
Peripheral function by electrical nerve stimulation
| 6 weeks post-discharge |
| Maximal oxygen uptake (VO2max) | measured by effort test | 6 weeks post-discharge |
| quality of sleep | measured by actigraphy | 6 weeks post-discharge |
| muscle volume | with Magnetic resonance imaging | 6 weeks post-discharge |
| metabolic fatigue | measured by a Phosphorus 31 Nuclear magnetic resonance test | 6 weeks post-discharge |
| microbiote intestinal | stool analysis (concerns only the patients of Saint Etienne) | baseline and 6 months |
| Lyon |
| France |
| Hôpital Croix Rousse - HCL | Lyon | France |
| Centre Hospitalier de Lyon Sud | Pierre-Bénite | 69310 | France |
| Hôpital privé de la Loire | Saint-Etienne | 42000 | France |
| Chu Saint-Etienne | Saint-Etienne | 42055 | France |
| Clinique Mutualiste Saint Etienne | Saint-Etienne | 42100 | France |
| Hôpital Henry Gabrielle | Saint-Genis-Laval | 69230 | France |
| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D006403 | Hematologic Tests |
| D056044 | Actigraphy |
| D009780 | Occult Blood |
| D015930 | Diet Records |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008991 | Monitoring, Physiologic |
| D061725 | Accelerometry |
| D011996 | Records |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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