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

Primary Purpose

Chronic Fatigue Syndrome, Intensive Care Unit, Muscle

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires
blood test
Maximal effort test
actigraphy
Neuromuscular evaluation
stool analysis
food diary
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Fatigue Syndrome focused on measuring Neuromuscular function, Fatigability

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Grenoble
  • Clinique de la Sauvegarde - Lyon
  • Hôpital Croix Rousse - HCL
  • Centre Hospitalier de Lyon SudRecruiting
  • Chu Saint-EtienneRecruiting
  • Clinique Mutualiste Saint Etienne
  • Hôpital Henry GabrielleRecruiting
  • Hôpital privé de la Loire

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

"Non-fatigued" patients who have been in intensive care units

"Fatigued" patients who have been in intensive care units

patients who have not been in intensive care units

Arm Description

Outcomes

Primary Outcome Measures

voluntary maximum force reduction

Secondary Outcome Measures

Neuromuscular function : cortical activity
Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation
Neuromuscular function : Peripheral function
Peripheral function by electrical nerve stimulation
Maximal oxygen uptake (VO2max)
measured by effort test
quality of sleep
measured by actigraphy
muscle volume
with Magnetic resonance imaging
metabolic fatigue
measured by a Phosphorus 31 Nuclear magnetic resonance test
microbiote intestinal
stool analysis (concerns only the patients of Saint Etienne)

Full Information

First Posted
April 24, 2020
Last Updated
April 14, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
University of Saint-Etienne, Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
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1. Study Identification

Unique Protocol Identification Number
NCT04363606
Brief Title
Chronic Fatigue Etiology and Recovery in Covid-19 Patients: the Role of Fatigability
Acronym
FatCovid-19
Official Title
Chronic Fatigue Etiology and Recovery in Covid-19 Patients : the Role of Fatigability and Stay in Intensive Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
University of Saint-Etienne, Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome, Intensive Care Unit, Muscle
Keywords
Neuromuscular function, Fatigability

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"Non-fatigued" patients who have been in intensive care units
Arm Type
Experimental
Arm Title
"Fatigued" patients who have been in intensive care units
Arm Type
Experimental
Arm Title
patients who have not been in intensive care units
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Quality of life Depression Physical pain Social provisions Quality of sleep
Intervention Type
Biological
Intervention Name(s)
blood test
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Maximal effort test
Intervention Description
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.
Intervention Type
Device
Intervention Name(s)
actigraphy
Intervention Description
assessment of sleep quality
Intervention Type
Device
Intervention Name(s)
Neuromuscular evaluation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
stool analysis
Intervention Description
analyze the composition of the intestinal microbiote. concerns only the patients of Saint Etienne
Intervention Type
Other
Intervention Name(s)
food diary
Intervention Description
3 days of information to determine nutrient intakes. concerns only the patients of Saint Etienne
Primary Outcome Measure Information:
Title
voluntary maximum force reduction
Time Frame
6 weeks post-discharge
Secondary Outcome Measure Information:
Title
Neuromuscular function : cortical activity
Description
Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation
Time Frame
6 weeks post-discharge
Title
Neuromuscular function : Peripheral function
Description
Peripheral function by electrical nerve stimulation
Time Frame
6 weeks post-discharge
Title
Maximal oxygen uptake (VO2max)
Description
measured by effort test
Time Frame
6 weeks post-discharge
Title
quality of sleep
Description
measured by actigraphy
Time Frame
6 weeks post-discharge
Title
muscle volume
Description
with Magnetic resonance imaging
Time Frame
6 weeks post-discharge
Title
metabolic fatigue
Description
measured by a Phosphorus 31 Nuclear magnetic resonance test
Time Frame
6 weeks post-discharge
Title
microbiote intestinal
Description
stool analysis (concerns only the patients of Saint Etienne)
Time Frame
baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jérome MOREL, MD PhD
Phone
0477828553
Ext
+33
Email
jerome.morel@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérome MOREL, MD PhD
Organizational Affiliation
CHU de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre BOUZAT, MD PhD
First Name & Middle Initial & Last Name & Degree
Pierre BOUZAT, MD PhD
First Name & Middle Initial & Last Name & Degree
Renaud TAMISIER, MD PhD
First Name & Middle Initial & Last Name & Degree
Stéphane DOUTRELEAU, MD PhD
Facility Name
Clinique de la Sauvegarde - Lyon
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier DESEBBE, MD
First Name & Middle Initial & Last Name & Degree
Olivier DESEBBE, MD
Facility Name
Hôpital Croix Rousse - HCL
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline GUICHON, MD
First Name & Middle Initial & Last Name & Degree
Céline GUICHON, MD
First Name & Middle Initial & Last Name & Degree
Mélanie PRUDENT, MD
First Name & Middle Initial & Last Name & Degree
Emeric STAUFFER, MD
Facility Name
Centre Hospitalier de Lyon Sud
City
Pierre-benite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien COURAUD, MD PhD
First Name & Middle Initial & Last Name & Degree
Sébastien COURAUD, MD PhD
Facility Name
Chu Saint-Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérome MOREL, MD PhD
Phone
(0)477828553
Ext
+33
Email
jerome.morel@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Pierre CROISILLE, MD PhD
First Name & Middle Initial & Last Name & Degree
Léonard FEASSON, MD PhD
First Name & Middle Initial & Last Name & Degree
Jérôme MOREL, MD PhD
First Name & Middle Initial & Last Name & Degree
Guillaume THIERY, MD PhD
First Name & Middle Initial & Last Name & Degree
Pascal GIRAUX, MD
First Name & Middle Initial & Last Name & Degree
Lydia OUJAMAA, MD
First Name & Middle Initial & Last Name & Degree
Clément Foschia, MD
First Name & Middle Initial & Last Name & Degree
Marine Sorg, MD
Facility Name
Clinique Mutualiste Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent GAUTHIER, MD
First Name & Middle Initial & Last Name & Degree
Vincent GAUTHIER, MD
Facility Name
Hôpital Henry Gabrielle
City
Saint-Genis-Laval
ZIP/Postal Code
69230
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie JACQUIN-COURTOIS, MD PhD
First Name & Middle Initial & Last Name & Degree
Sophie JACQUIN-COURTOIS, MD PhD
Facility Name
Hôpital privé de la Loire
City
Saint-Étienne
ZIP/Postal Code
42000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent GERGELE, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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