Chronic Fatigue Etiology and Recovery in Covid-19 Patients: the Role of Fatigability
NCT ID: NCT04363606
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
69 participants
INTERVENTIONAL
2020-05-27
2022-03-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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"Non-fatigued" patients who have been in intensive care units
Questionnaires
Quality of life Depression Physical pain Social provisions Quality of sleep
blood test
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
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.
actigraphy
assessment of sleep quality
Neuromuscular evaluation
* The maximum isometric force produced by the knee extensors will be measured on the ergometer
* the intensity of muscular electrical activity recorded by surface electromyography
* Peripheral nerve stimulation
* Transcranial magnetic stimulation
* Magnetic resonance imaging
stool analysis
analyze the composition of the intestinal microbiote. concerns only the patients of Saint Etienne
food diary
3 days of information to determine nutrient intakes. concerns only the patients of Saint Etienne
"Fatigued" patients who have been in intensive care units
Questionnaires
Quality of life Depression Physical pain Social provisions Quality of sleep
blood test
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
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.
actigraphy
assessment of sleep quality
Neuromuscular evaluation
* The maximum isometric force produced by the knee extensors will be measured on the ergometer
* the intensity of muscular electrical activity recorded by surface electromyography
* Peripheral nerve stimulation
* Transcranial magnetic stimulation
* Magnetic resonance imaging
stool analysis
analyze the composition of the intestinal microbiote. concerns only the patients of Saint Etienne
food diary
3 days of information to determine nutrient intakes. concerns only the patients of Saint Etienne
patients who have not been in intensive care units
Questionnaires
Quality of life Depression Physical pain Social provisions Quality of sleep
blood test
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
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.
actigraphy
assessment of sleep quality
Neuromuscular evaluation
* The maximum isometric force produced by the knee extensors will be measured on the ergometer
* the intensity of muscular electrical activity recorded by surface electromyography
* Peripheral nerve stimulation
* Transcranial magnetic stimulation
* Magnetic resonance imaging
stool analysis
analyze the composition of the intestinal microbiote. concerns only the patients of Saint Etienne
food diary
3 days of information to determine nutrient intakes. concerns only the patients of Saint Etienne
Interventions
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Questionnaires
Quality of life Depression Physical pain Social provisions Quality of sleep
blood test
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
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.
actigraphy
assessment of sleep quality
Neuromuscular evaluation
* The maximum isometric force produced by the knee extensors will be measured on the ergometer
* the intensity of muscular electrical activity recorded by surface electromyography
* Peripheral nerve stimulation
* Transcranial magnetic stimulation
* Magnetic resonance imaging
stool analysis
analyze the composition of the intestinal microbiote. concerns only the patients of Saint Etienne
food diary
3 days of information to determine nutrient intakes. concerns only the patients of Saint Etienne
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
35 Years
80 Years
ALL
No
Sponsors
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University of Saint-Etienne
UNKNOWN
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
OTHER
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Jérome MOREL, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint Etienne
Locations
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CHU de Grenoble
Grenoble, , France
Clinique de la Sauvegarde - Lyon
Lyon, , France
Hôpital Croix Rousse - HCL
Lyon, , France
Centre Hospitalier de Lyon Sud
Pierre-Bénite, , France
Hôpital privé de la Loire
Saint-Etienne, , France
Chu Saint-Etienne
Saint-Etienne, , France
Clinique Mutualiste Saint Etienne
Saint-Etienne, , France
Hôpital Henry Gabrielle
Saint-Genis-Laval, , France
Countries
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References
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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.
Other Identifiers
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20CH085
Identifier Type: -
Identifier Source: org_study_id
2020-A00982-37
Identifier Type: OTHER
Identifier Source: secondary_id
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