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

Not Applicable

Withdrawn

• Conditions: Chronic Fatigue Syndrome; Intensive Care Unit; Muscle
• Interventions: Other: Questionnaires; Biological: blood test; Other: Maximal effort test; Device: actigraphy; Device: Neuromuscular evaluation

• Registration Number: NCT03849326
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26
• Study Start: 2023-12
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Fatigued" patients	Questionnaires	-
"Non-fatigued" patients	Questionnaires	-
"Fatigued" patients	actigraphy	-
"Non-fatigued" patients	actigraphy	-
"Non-fatigued" patients	Neuromuscular evaluation	-
"Non-fatigued" patients	Maximal effort test	-
"Non-fatigued" patients	blood test	-
"Fatigued" patients	blood test	-
"Fatigued" patients	Maximal effort test	-
"Fatigued" patients	Neuromuscular evaluation	-

Primary Outcome Measures

Name	Time	Method
voluntary maximum force reduction	at 2 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital privé de la Loire; 🇫🇷 Saint-Étienne, France