Chronic Fatigue Etiology in Intensive Care Unit Survivors: the Role of Neuromuscular Function
NCT ID: NCT03849326
Last Updated: 2023-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-12-31
2025-04-30
Brief Summary
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The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in this feeling of chronic fatigue. 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 will allow to optimize rehabilitation treatments to decrease the apparition/persistence of chronic fatigue and in fine improve life quality.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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"Non-fatigued" patients
Questionnaires
Quality of life Depression Physical pain Social provisions Quality of sleep
blood test
complete blood count and cytokine concentration
Maximal effort test
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.
actigraphy
assessment of sleep quality
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 (optional)
"Fatigued" patients
Questionnaires
Quality of life Depression Physical pain Social provisions Quality of sleep
blood test
complete blood count and cytokine concentration
Maximal effort test
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.
actigraphy
assessment of sleep quality
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 (optional)
Interventions
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Questionnaires
Quality of life Depression Physical pain Social provisions Quality of sleep
blood test
complete blood count and cytokine concentration
Maximal effort test
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.
actigraphy
assessment of sleep quality
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 (optional)
Eligibility Criteria
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Inclusion Criteria
* IGS2 score (severity in resuscitation) \> 15
* FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) score ≥ 36 or a score ≤ 32
* intensive care unit discharge in ≥ 6 months and ≤ 5 years preceding the study
* Approval received from a physician
* Command of the French language
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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University of Saint-Etienne
UNKNOWN
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Jérome MOREL, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint Etienne
Locations
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Hôpital privé de la Loire
Saint-Etienne, , France
Countries
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Other Identifiers
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2018-A03511-54
Identifier Type: OTHER
Identifier Source: secondary_id
18CH175
Identifier Type: -
Identifier Source: org_study_id
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