Chronic Fatigue Etiology and Recovery in Covid-19 Patients: the Role of Fatigability

Intensive Care Unit Clinical Trial

— FatCovid-19  

Official title:

Chronic Fatigue Etiology and Recovery in Covid-19 Patients : the Role of Fatigability and Stay in Intensive Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04363606
• Other study ID #: 20CH085
• Secondary ID: 2020-A00982-37
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2020
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Jérome MOREL, MD PhD
• Phone: 0477828553
• Email: jerome.morel[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 2024
• Est. primary completion date: April 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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Intensive Care Unit
• Muscle

Intervention

Other:
• Questionnaires
Quality of life Depression Physical pain Social provisions Quality of sleep

Biological:
• blood test
complete blood count and cytokine concentration, TNF-alpha, LDL oxidized, AOPP, SOD, GPX, catalase, albumin, transthyretin, RBP, transferin, a-1 glycoprotein acide, ferritine, selenium, zinc, magnesium

Other:
• Maximal effort test
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.

Device:
• 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

Other:
• 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

Locations

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

Sponsors (3)

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

Country where clinical trial is conducted

France, 

Outcome

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