Chronic Fatigue SyndromeFatCovid-19NCT04363606
Chronic Fatigue Etiology and Recovery in Covid-19 Patients: the Role of Fatigability
A study testing Questionnaires, blood test and Maximal effort test in people with Chronic Fatigue Syndrome and Intensive Care Unit, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Chronic Fatigue Syndrome, Intensive Care Unit, Muscle
- What is being tested?
- Questionnaires, blood test and Maximal effort test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 8 sitesFrance
- Study dates
- 27 May 2020to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 9Show fewer
- Patients with psychiatric disorders
- Paraplegic and hemiplegic patients
- Addictive disorders
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU de Grenoble
Grenoble
Clinique de la Sauvegarde - Lyon
Lyon
Hôpital Croix Rousse - HCL
Lyon
Centre Hospitalier de Lyon Sud
Pierre-Bénite, 69310
Hôpital privé de la Loire
Saint-Etienne, 42000
Chu Saint-Etienne
Saint-Etienne, 42055
Clinique Mutualiste Saint Etienne
Saint-Etienne, 42100
Hôpital Henry Gabrielle
Saint-Genis-Laval, 69230
About this study
Official title: Chronic Fatigue Etiology and Recovery in Covid-19 Patients : the Role of Fatigability and Stay in Intensive Care
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.
- Conditions
- Chronic Fatigue Syndrome, Intensive Care Unit, Muscle
- Being tested
- Questionnaires, blood test, Maximal effort test, actigraphy, Neuromuscular evaluation
- Keywords
- Neuromuscular function, Fatigability
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Quality of life Depression Physical pain Social provisions Quality of sleep
blood testBiological
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 testOther
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.
actigraphyDevice
assessment of sleep quality
Neuromuscular evaluationDevice
- 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 analysisOther
analyze the composition of the intestinal microbiote. concerns only the patients of Saint Etienne
food diaryOther
3 days of information to determine nutrient intakes. concerns only the patients of Saint Etienne
| Study group | Role | What they receive |
|---|---|---|
| "Non-fatigued" patients who have been in intensive care units | Experimental | Not described Receives: Other: Questionnaires; Biological: blood test; Other: Maximal effort test; Device: actigraphy; Device: Neuromuscular evaluation; Other: stool analysis; Other: food diary |
| "Fatigued" patients who have been in intensive care units | Experimental | Not described Receives: Other: Questionnaires; Biological: blood test; Other: Maximal effort test; Device: actigraphy; Device: Neuromuscular evaluation; Other: stool analysis; Other: food diary |
| patients who have not been in intensive care units | Experimental | Not described Receives: Other: Questionnaires; Biological: blood test; Other: Maximal effort test; Device: actigraphy; Device: Neuromuscular evaluation; Other: stool analysis; Other: food diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
voluntary maximum force reduction
Measured: 6 weeks post-discharge
Secondary outcomes (7)
Neuromuscular function : cortical activity
Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation
Measured: 6 weeks post-discharge
Neuromuscular function : Peripheral function
Peripheral function by electrical nerve stimulation
Measured: 6 weeks post-discharge
Maximal oxygen uptake (VO2max)
measured by effort test
Measured: 6 weeks post-discharge
quality of sleep
measured by actigraphy
Measured: 6 weeks post-discharge
muscle volume
with Magnetic resonance imaging
Measured: 6 weeks post-discharge
metabolic fatigue
measured by a Phosphorus 31 Nuclear magnetic resonance test
Measured: 6 weeks post-discharge
microbiote intestinal
stool analysis (concerns only the patients of Saint Etienne)
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start27 May 2020
- Primary completion26 Aug 2021
- Study completion1 Mar 2022
Why it stopped: under-inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Saint-Etienne, Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Responsible party
- Sponsor
- Investigators
- Jérome MOREL, MD PhD, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363606
- Sponsor's protocol ID
- 20CH085
- Other IDs
- 2020-A00982-37
- Acronym
- FatCovid-19
- Status last verified
- Mar 2025
- First submitted
- 24 Apr 2020
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38742855
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Fatigue Etiology and Recovery in Covid-19 Patients : the Role of Fatigability and Stay in Intensive Care
- ClinicalTrials.gov ID
- NCT04363606
- Acronym / sponsor ID
- FatCovid-19 / 20CH085
- Conditions
- Chronic Fatigue Syndrome, Intensive Care Unit, Muscle
- Keywords
- Neuromuscular function, Fatigability
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: under-inclusion
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- University of Saint-Etienne, Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Study start
- 27 May 2020 (actual)
- Primary completion
- 26 Aug 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Non-fatigued" patients who have been in intensive care units | Experimental | Other: Questionnaires, Biological: blood test, Other: Maximal effort test, Device: actigraphy, Device: Neuromuscular evaluation, Other: stool analysis, Other: food diary |
| "Fatigued" patients who have been in intensive care units | Experimental | Other: Questionnaires, Biological: blood test, Other: Maximal effort test, Device: actigraphy, Device: Neuromuscular evaluation, Other: stool analysis, Other: food diary |
| patients who have not been in intensive care units | Experimental | Other: Questionnaires, Biological: blood test, Other: Maximal effort test, Device: actigraphy, Device: Neuromuscular evaluation, Other: stool analysis, Other: food diary |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuality of life Depression Physical pain Social provisions Quality of sleep | Other | "Fatigued" patients who have been in intensive care units, "Non-fatigued" patients who have been in intensive care units, patients who have not been in intensive care units |
| blood testcomplete 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 | Biological | "Fatigued" patients who have been in intensive care units, "Non-fatigued" patients who have been in intensive care units, patients who have not been in intensive care units |
| Maximal effort testThe maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory. | Other | "Fatigued" patients who have been in intensive care units, "Non-fatigued" patients who have been in intensive care units, patients who have not been in intensive care units |
| actigraphyassessment of sleep quality | Device | "Fatigued" patients who have been in intensive care units, "Non-fatigued" patients who have been in intensive care units, patients who have not been in intensive care units |
| 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 | Device | "Fatigued" patients who have been in intensive care units, "Non-fatigued" patients who have been in intensive care units, patients who have not been in intensive care units |
| stool analysisanalyze the composition of the intestinal microbiote. concerns only the patients of Saint Etienne | Other | "Fatigued" patients who have been in intensive care units, "Non-fatigued" patients who have been in intensive care units, patients who have not been in intensive care units |
| food diary3 days of information to determine nutrient intakes. concerns only the patients of Saint Etienne | Other | "Fatigued" patients who have been in intensive care units, "Non-fatigued" patients who have been in intensive care units, patients who have not been in intensive care units |
Primary outcome
voluntary maximum force reduction
Time frame: 6 weeks post-discharge
7 secondary outcomes
Neuromuscular function : cortical activity
Time frame: 6 weeks post-discharge
Neuromuscular function : Peripheral function
Time frame: 6 weeks post-discharge
Maximal oxygen uptake (VO2max)
Time frame: 6 weeks post-discharge
quality of sleep
Time frame: 6 weeks post-discharge
muscle volume
Time frame: 6 weeks post-discharge
metabolic fatigue
Time frame: 6 weeks post-discharge
microbiote intestinal
Time frame: baseline and 6 months
Results and safety
The study was stopped early (reason given: under-inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Derived from this study: PubMed 38742855Kennouche 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérome MOREL, MD PhD principal investigator
CHU de Saint Etienne
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires, blood test and Maximal effort test in people with Chronic Fatigue Syndrome and Intensive Care Unit, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: under-inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
voluntary maximum force reduction (time frame: 6 weeks post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04363606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.