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

Intensive Care Unit Clinical Trial

— FatPostRéa  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03849326
• Other study ID #: 18CH175
• Secondary ID: 2018-A03511-54
• Status: Withdrawn
• Phase: N/A
• Start date: December 2023
• Est. completion date: April 2025

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Intensive Care Unit
• Muscle

Intervention

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
• 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)

Locations

Country	Name	City	State
France	Hôpital privé de la Loire	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	University of Saint-Etienne

Country where clinical trial is conducted

France, 

Outcome

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