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

NCT03849326 | Withdrawn

• 2 other identifiers: 18CH1752018-A03511-54
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Syndrome; Intensive Care Unit; Muscle

Keywords

Neuromuscular function

Outcome Measures

Primary Outcomes (1)

• voluntary maximum force reduction

  at 2 weeks

Secondary Outcomes (6)

• Neuromuscular function : cortical activity

  at 2 weeks

• Neuromuscular function : Peripheral function

  at visit 2

• Maximal oxygen uptake (VO2max)

  at 2 weeks

• quality of sleep

  at baseline

• Quadriceps muscle volume (optional)

  at 3 weeks

Study Arms (2)

"Non-fatigued" patients

EXPERIMENTAL

Other: Questionnaires; Biological: blood test; Other: Maximal effort test; Device: actigraphy; Device: Neuromuscular evaluation

"Fatigued" patients

EXPERIMENTAL

Other: Questionnaires; Biological: blood test; Other: Maximal effort test; Device: actigraphy; Device: Neuromuscular evaluation

Interventions

Questionnaires OTHER

Quality of life Depression Physical pain Social provisions Quality of sleep

"Fatigued" patients; "Non-fatigued" patients

blood test BIOLOGICAL

complete blood count and cytokine concentration

"Fatigued" patients; "Non-fatigued" patients

Maximal effort test OTHER

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

"Fatigued" patients; "Non-fatigued" patients

actigraphy DEVICE

assessment of sleep quality

"Fatigued" patients; "Non-fatigued" patients

Neuromuscular evaluation DEVICE

* 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)

"Fatigued" patients; "Non-fatigued" patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• University of Saint-Etienne: collaborator

Study Sites (1)

Hôpital privé de la Loire

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Surveys and Questionnaires; Hematologic Tests; Actigraphy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic; Accelerometry

Study Officials

• Jérome MOREL, MD PhD

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 21, 2019
• Study Start: December 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)