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

Not Applicable

Terminated

• Conditions: Muscle; Chronic Fatigue Syndrome; Intensive Care Unit
• Interventions: Other: Questionnaires; Biological: blood test; Other: Maximal effort test; Device: actigraphy; Device: Neuromuscular evaluation; Other: stool analysis; Other: food diary

• Registration Number: NCT04363606
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-27
• Study Start: 2020-05-27
• Primary Completion: 2021-08-26
• Study Completion: 2022-03-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients who have not been in intensive care units	Neuromuscular evaluation	-
"Non-fatigued" patients who have been in intensive care units	actigraphy	-
"Non-fatigued" patients who have been in intensive care units	Maximal effort test	-
patients who have not been in intensive care units	Maximal effort test	-
"Non-fatigued" patients who have been in intensive care units	blood test	-
"Fatigued" patients who have been in intensive care units	Questionnaires	-
"Fatigued" patients who have been in intensive care units	Neuromuscular evaluation	-
"Fatigued" patients who have been in intensive care units	food diary	-
"Fatigued" patients who have been in intensive care units	stool analysis	-
"Non-fatigued" patients who have been in intensive care units	stool analysis	-
"Non-fatigued" patients who have been in intensive care units	food diary	-
patients who have not been in intensive care units	stool analysis	-
patients who have not been in intensive care units	food diary	-
patients who have not been in intensive care units	actigraphy	-
"Fatigued" patients who have been in intensive care units	blood test	-
patients who have not been in intensive care units	Questionnaires	-
patients who have not been in intensive care units	blood test	-
"Fatigued" patients who have been in intensive care units	actigraphy	-
"Non-fatigued" patients who have been in intensive care units	Questionnaires	-
"Non-fatigued" patients who have been in intensive care units	Neuromuscular evaluation	-
"Fatigued" patients who have been in intensive care units	Maximal effort test	-

Primary Outcome Measures

Name	Time	Method
voluntary maximum force reduction	6 weeks post-discharge

Secondary Outcome Measures

Name	Time	Method
Neuromuscular function : cortical activity	6 weeks post-discharge	Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation
Neuromuscular function : Peripheral function	6 weeks post-discharge	Peripheral function by electrical nerve stimulation
Maximal oxygen uptake (VO2max)	6 weeks post-discharge	measured by effort test
metabolic fatigue	6 weeks post-discharge	measured by a Phosphorus 31 Nuclear magnetic resonance test
quality of sleep	6 weeks post-discharge	measured by actigraphy
muscle volume	6 weeks post-discharge	with Magnetic resonance imaging
microbiote intestinal	baseline and 6 months	stool analysis (concerns only the patients of Saint Etienne)

Trial Locations

Locations (8)

Centre Hospitalier de Lyon Sud; 🇫🇷 Pierre-benite, France

Chu Saint-Etienne; 🇫🇷 Saint Etienne, France

Clinique Mutualiste Saint Etienne; 🇫🇷 Saint Etienne, France

Hôpital Croix Rousse - HCL; 🇫🇷 Lyon, France

CHU de Grenoble; 🇫🇷 Grenoble, France

Clinique de la Sauvegarde - Lyon; 🇫🇷 Lyon, France

Hôpital privé de la Loire; 🇫🇷 Saint-Étienne, France

Hôpital Henry Gabrielle; 🇫🇷 Saint-Genis-Laval, France