Intensive Care Unit Clinical Trial
— FatCovid-19Official title:
Chronic Fatigue Etiology and Recovery in Covid-19 Patients : the Role of Fatigability and Stay in Intensive Care
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.
Status | Recruiting |
Enrollment | 102 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 80 Years |
Eligibility | Inclusion Criteria for patients who have been in intensive care : - Diagnosed with Covid-19 - Ventilated in ICU for at least 3 consecutive days - ICU discharge between 4 and 8 weeks - Approval received from a physician - Command of the French language Inclusion Criteria for patients who have NOT been in intensive care : - Diagnosed with Covid-19 : positive serological test or positive PCR test following nasopharyngeal swabbing - Approval received from a physician - Command of the French language Exclusion Criteria: - Taking neuroactive substances that can alter corticospinal excitability - Patients with co-morbidities leading to significant fatigue: e.g. cancerous pathologies, sleep apnea - Patients with neurodegenerative or neuromuscular disease - Contraindication to the application of a magnetic field - Contraindication to the practice of Magnetic Resonance Imaging - Participant is pregnant - Patients with psychiatric disorders - Paraplegic and hemiplegic patients - Addictive disorders |
Country | Name | City | State |
---|---|---|---|
France | CHU de Grenoble | Grenoble | |
France | Clinique de la Sauvegarde - Lyon | Lyon | |
France | Hôpital Croix Rousse - HCL | Lyon | |
France | Centre Hospitalier de Lyon Sud | Pierre-benite | |
France | Chu Saint-Etienne | Saint Etienne | |
France | Clinique Mutualiste Saint Etienne | Saint Etienne | |
France | Hôpital privé de la Loire | Saint-Étienne | |
France | Hôpital Henry Gabrielle | Saint-Genis-Laval |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques, University of Saint-Etienne |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | voluntary maximum force reduction | 6 weeks post-discharge | ||
Secondary | Neuromuscular function : cortical activity | Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation | 6 weeks post-discharge | |
Secondary | Neuromuscular function : Peripheral function | Peripheral function by electrical nerve stimulation | 6 weeks post-discharge | |
Secondary | Maximal oxygen uptake (VO2max) | measured by effort test | 6 weeks post-discharge | |
Secondary | quality of sleep | measured by actigraphy | 6 weeks post-discharge | |
Secondary | muscle volume | with Magnetic resonance imaging | 6 weeks post-discharge | |
Secondary | metabolic fatigue | measured by a Phosphorus 31 Nuclear magnetic resonance test | 6 weeks post-discharge | |
Secondary | microbiote intestinal | stool analysis (concerns only the patients of Saint Etienne) | baseline and 6 months |
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