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

NCT04363606 | Terminated

• 2 other identifiers: 20CH0852020-A00982-37
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 8

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.

Conditions

Chronic Fatigue Syndrome; Intensive Care Unit; Muscle

Keywords

Neuromuscular function; Fatigability

Outcome Measures

Primary Outcomes (1)

• voluntary maximum force reduction

  6 weeks post-discharge

Secondary Outcomes (7)

• Neuromuscular function : cortical activity

  6 weeks post-discharge

• Neuromuscular function : Peripheral function

  6 weeks post-discharge

• Maximal oxygen uptake (VO2max)

  6 weeks post-discharge

• quality of sleep

  6 weeks post-discharge

• muscle volume

  6 weeks post-discharge

Study Arms (3)

"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

Interventions

Questionnaires OTHER

Quality of life Depression Physical pain Social provisions Quality of sleep

"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 test BIOLOGICAL

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

"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 test OTHER

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

"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

actigraphy DEVICE

assessment of sleep quality

"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 DEVICE

* 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

"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 analysis OTHER

analyze the composition of the intestinal microbiote. concerns only the patients of Saint Etienne

"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 diary OTHER

3 days of information to determine nutrient intakes. concerns only the patients of Saint Etienne

"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

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Diagnosed with Covid-19 : positive serological test or positive PCR test following nasopharyngeal swabbing
• Approval received from a physician
• Command of the French language

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• University of Saint-Etienne: collaborator
• Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques: collaborator

Study Sites (8)

CHU de Grenoble

Grenoble, France

Location

Clinique de la Sauvegarde - Lyon

Lyon, France

Location

Hôpital Croix Rousse - HCL

Lyon, France

Location

Centre Hospitalier de Lyon Sud

Pierre-Bénite, 69310, France

Location

Hôpital privé de la Loire

Saint-Etienne, 42000, France

Location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

Clinique Mutualiste Saint Etienne

Saint-Etienne, 42100, France

Location

Hôpital Henry Gabrielle

Saint-Genis-Laval, 69230, France

Location

Related Publications (1)

• 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.

  PMID: 38742855 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Surveys and Questionnaires; Hematologic Tests; Actigraphy; Occult Blood; Diet Records

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic; Accelerometry; Records; Organization and Administration; Health Services Administration

Study Officials

• Jérome MOREL, MD PhD

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 27, 2020
• Study Start: May 27, 2020
• Primary Completion: August 26, 2021
• Study Completion: March 1, 2022
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)