search
Back to results

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

Primary Purpose

Chronic Fatigue Syndrome, Intensive Care Unit, Muscle

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires
blood test
Maximal effort test
actigraphy
Neuromuscular evaluation
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Fatigue Syndrome focused on measuring Neuromuscular function

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital privé de la Loire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

"Non-fatigued" patients

"Fatigued" patients

Arm Description

Outcomes

Primary Outcome Measures

voluntary maximum force reduction

Secondary Outcome Measures

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

Full Information

First Posted
February 19, 2019
Last Updated
April 24, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
University of Saint-Etienne
search

1. Study Identification

Unique Protocol Identification Number
NCT03849326
Brief Title
Chronic Fatigue Etiology in Intensive Care Unit Survivors: the Role of Neuromuscular Function
Acronym
FatPostRéa
Official Title
Chronic Fatigue Etiology in Intensive Care Unit Survivors: the Role of Neuromuscular Function
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Due to the health crisis and the lack of staff in the department no inclusion could be realized
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
University of Saint-Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome, Intensive Care Unit, Muscle
Keywords
Neuromuscular function

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Non-fatigued" patients
Arm Type
Experimental
Arm Title
"Fatigued" patients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Quality of life Depression Physical pain Social provisions Quality of sleep
Intervention Type
Biological
Intervention Name(s)
blood test
Intervention Description
complete blood count and cytokine concentration
Intervention Type
Other
Intervention Name(s)
Maximal effort test
Intervention Description
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.
Intervention Type
Device
Intervention Name(s)
actigraphy
Intervention Description
assessment of sleep quality
Intervention Type
Device
Intervention Name(s)
Neuromuscular evaluation
Intervention Description
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)
Primary Outcome Measure Information:
Title
voluntary maximum force reduction
Time Frame
at 2 weeks
Secondary Outcome Measure Information:
Title
Neuromuscular function : cortical activity
Description
Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation
Time Frame
at 2 weeks
Title
Neuromuscular function : Peripheral function
Description
Peripheral function by electrical nerve stimulation
Time Frame
at visit 2
Title
Maximal oxygen uptake (VO2max)
Description
measured by effort test
Time Frame
at 2 weeks
Title
quality of sleep
Description
measured by actigraphy
Time Frame
at baseline
Title
Quadriceps muscle volume (optional)
Description
with Magnetic resonance imaging
Time Frame
at 3 weeks
Title
muscle dysfunction (optional)
Description
measured by a Phosphorus 31 Nuclear magnetic resonance test
Time Frame
at 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérome MOREL, MD PhD
Organizational Affiliation
CHU de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital privé de la Loire
City
Saint-Étienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs