Clinical trial NCT04363606: Chronic Fatigue Etiology and Recovery in Covid-19 Patients: the Role of Fatigability
Official title: Chronic Fatigue Etiology and Recovery in Covid-19 Patients : the Role of Fatigability and Stay in Intensive Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Fatigue Syndrome
Intensive Care Unit
Muscle
Keywords: Neuromuscular function
Fatigability
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: University of Saint-Etienne
name: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
First posted: 2020-04-27
Enrollment: 69
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: voluntary maximum force reduction
timeFrame: 6 weeks post-discharge
Secondary outcomes:
measure: Neuromuscular function : cortical activity
timeFrame: 6 weeks post-discharge
measure: Neuromuscular function : Peripheral function
timeFrame: 6 weeks post-discharge
measure: Maximal oxygen uptake (VO2max)
timeFrame: 6 weeks post-discharge
measure: quality of sleep
timeFrame: 6 weeks post-discharge
measure: muscle volume
timeFrame: 6 weeks post-discharge
measure: metabolic fatigue
timeFrame: 6 weeks post-discharge
measure: microbiote intestinal
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lyon
country: France
facility: Clinique de la Sauvegarde - Lyon
city: Lyon
country: France
facility: Hôpital Croix Rousse - HCL
city: Pierre-benite
country: France
facility: Centre Hospitalier de Lyon Sud
city: Saint Etienne
country: France
facility: Chu Saint-Etienne
city: Saint Etienne
country: France
facility: Clinique Mutualiste Saint Etienne
city: Saint-Genis-Laval
country: France
facility: Hôpital Henry Gabrielle
city: Saint-Étienne
country: France
facility: Hôpital privé de la Loire
Study officials:
affiliation: CHU de Saint Etienne
name: Jérome MOREL, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: