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

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Muscle; Intensive Care Unit; Chronic Fatigue Syndrome

Treatments: Device: Neuromuscular evaluation; Device: actigraphy; Other: Questionnaires; Other: stool analysis; Other: food diary; Biological: blood test; Other: Maximal effort test

Study type: Interventional

Funder types: Other

Identifiers

NCT04363606

2020-A00982-37 (Other Identifier)

20CH085

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 3 patient groups

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

Experimental group

Treatment:

Other: Maximal effort test

Biological: blood test

Other: food diary

Other: stool analysis

Device: actigraphy

Other: Questionnaires

Device: Neuromuscular evaluation

"Fatigued" patients who have been in intensive care units

Experimental group

Treatment:

Other: Maximal effort test

Biological: blood test

Other: food diary

Other: stool analysis

Device: actigraphy

Other: Questionnaires

Device: Neuromuscular evaluation

patients who have not been in intensive care units

Experimental group

Treatment:

Other: Maximal effort test

Biological: blood test

Other: food diary

Other: stool analysis

Device: actigraphy

Other: Questionnaires

Device: Neuromuscular evaluation