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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 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
Health authority
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 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

Study Design


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
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