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

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT03849326
• Collaborator: University of Saint-Etienne (Other)
• Enrollment: 50
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 13
• Patients Per Site: 25
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. voluntary maximum force reduction [at 2 weeks]

Secondary Outcome Measures

1. Neuromuscular function : cortical activity [at 2 weeks]

   Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation

2. Neuromuscular function : Peripheral function [at visit 2]

   Peripheral function by electrical nerve stimulation

3. Maximal oxygen uptake (VO2max) [at 2 weeks]

   measured by effort test

4. quality of sleep [at baseline]

   measured by actigraphy

5. Quadriceps muscle volume (optional) [at 3 weeks]

   with Magnetic resonance imaging

6. muscle dysfunction (optional) [at 3 weeks]

   measured by a Phosphorus 31 Nuclear magnetic resonance test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Saint-Etienne	Saint Etienne		France	42055
2	Hôpital privé de la Loire	Saint-Étienne		France	42000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne
• University of Saint-Etienne

Investigators

• Principal Investigator: Jérome MOREL, MD PhD, CHU de Saint Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT03849326
• Other Study ID Numbers: 18CH175; 2018-A03511-54
• First Posted: Feb 21, 2019
• Last Update Posted: Dec 13, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Fatigue Syndrome, Chronic; Fatigue

Study Results

No Results Posted as of Dec 13, 2021