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Chronic Fatigue Etiology in Intensive Care Unit Survivors: the Role of Neuromuscular Function (FatPostRéa)

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ClinicalTrials.gov Identifier: NCT03849326
Recruitment Status : Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
University of Saint-Etienne
Information provided by (Responsible Party):
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 chronic fatigue affects 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 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.


Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Intensive Care Unit Muscle Other: Questionnaires Biological: blood test Other: Maximal effort test Device: actigraphy Device: Neuromuscular evaluation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Chronic Fatigue Etiology in Intensive Care Unit Survivors: the Role of Neuromuscular Function
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: "Non-fatigued" patients Other: Questionnaires
Quality of life Depression Physical pain Social provisions Quality of sleep

Biological: blood test
complete blood count and cytokine concentration

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

Device: actigraphy
assessment of sleep quality

Device: 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)

Experimental: "Fatigued" patients Other: Questionnaires
Quality of life Depression Physical pain Social provisions Quality of sleep

Biological: blood test
complete blood count and cytokine concentration

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

Device: actigraphy
assessment of sleep quality

Device: 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)




Primary Outcome Measures :
  1. voluntary maximum force reduction [ Time Frame: at 2 weeks ]

Secondary Outcome Measures :
  1. Neuromuscular function : cortical activity [ Time Frame: at 2 weeks ]
    Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation

  2. Neuromuscular function : Peripheral function [ Time Frame: at visit 2 ]
    Peripheral function by electrical nerve stimulation

  3. Maximal oxygen uptake (VO2max) [ Time Frame: at 2 weeks ]
    measured by effort test

  4. quality of sleep [ Time Frame: at baseline ]
    measured by actigraphy

  5. Quadriceps muscle volume (optional) [ Time Frame: at 3 weeks ]
    with Magnetic resonance imaging

  6. muscle dysfunction (optional) [ Time Frame: at 3 weeks ]
    measured by a Phosphorus 31 Nuclear magnetic resonance test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have been ventilated for at least 72 hours in the intensive care unit
  • 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:

  • Taking neuroactive substances that can alter corticospinal excitability
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849326


Contacts
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Contact: Jérome MOREL, MD PhD 0477828553 ext +33 jerome.morel@chu-st-etienne.fr

Locations
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France
Chu Saint-Etienne Not yet recruiting
Saint Etienne, France, 42055
Contact: Jérome MOREL, MD PhD    (0)477828553 ext +33    jerome.morel@chu-st-etienne.fr   
Sub-Investigator: Pierre CROISILLE, MD PhD         
Sub-Investigator: Léonard FEASSON, MD PhD         
Principal Investigator: Jérôme MOREL, MD PhD         
Hôpital privé de la Loire Not yet recruiting
Saint-Étienne, France, 42000
Principal Investigator: Laurent GERGELE, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
University of Saint-Etienne
Investigators
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Principal Investigator: Jérome MOREL, MD PhD CHU de Saint Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03849326     History of Changes
Other Study ID Numbers: 18CH175
2018-A03511-54 ( Other Identifier: ANSM )
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Neuromuscular function
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Fatigue
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases