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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Fatigue Syndrome; Intensive Care Unit; Muscle
• Intervention / Treatment: Other: Questionnaires; Other: Maximal effort test; Device: actigraphy; Biological: blood test; Device: Neuromuscular evaluation

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42000
    • Hôpital privé de la Loire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Non-fatigued" patients	Other: Questionnaires; Quality of life Depression Physical pain Social provisions Quality of sleep; 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; Biological: blood test; complete blood count and cytokine concentration; 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; 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; Biological: blood test; complete blood count and cytokine concentration; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
voluntary maximum force reduction	at 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuromuscular function : cortical activity	Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation	at 2 weeks
Neuromuscular function : Peripheral function	Peripheral function by electrical nerve stimulation	at visit 2
Maximal oxygen uptake (VO2max)	measured by effort test	at 2 weeks
quality of sleep	measured by actigraphy	at baseline
Quadriceps muscle volume (optional)	with Magnetic resonance imaging	at 3 weeks
muscle dysfunction (optional)	measured by a Phosphorus 31 Nuclear magnetic resonance test	at 3 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: University of Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2023
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Neuromuscular function
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Fatigue; Fatigue Syndrome, Chronic
• Other Study ID Numbers: 18CH175; 2018-A03511-54 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No