Chronic Fatigue SyndromeFatPostRéaNCT03849326
Chronic Fatigue Etiology in Intensive Care Unit Survivors: the Role of Neuromuscular Function
A study testing Questionnaires, blood test and Maximal effort test in people with Chronic Fatigue Syndrome and Intensive Care Unit, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Fatigue Syndrome, Intensive Care Unit, Muscle
- What is being tested?
- Questionnaires, blood test and Maximal effort test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2023to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Questionnaires, blood test, Maximal effort test, actigraphy, Neuromuscular evaluation
- Keywords
- Neuromuscular function
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Quality of life Depression Physical pain Social provisions Quality of sleep
blood testBiological
complete blood count and cytokine concentration
Maximal effort testOther
The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.
actigraphyDevice
assessment of sleep quality
Neuromuscular evaluationDevice
- 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)
| Study group | Role | What they receive |
|---|---|---|
| "Non-fatigued" patients | Experimental | Not described Receives: Other: Questionnaires; Biological: blood test; Other: Maximal effort test; Device: actigraphy; Device: Neuromuscular evaluation |
| "Fatigued" patients | Experimental | Not described Receives: Other: Questionnaires; Biological: blood test; Other: Maximal effort test; Device: actigraphy; Device: Neuromuscular evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
voluntary maximum force reduction
Measured: at 2 weeks
Secondary outcomes (6)
Neuromuscular function : cortical activity
Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation
Measured: at 2 weeks
Neuromuscular function : Peripheral function
Peripheral function by electrical nerve stimulation
Measured: at visit 2
Maximal oxygen uptake (VO2max)
measured by effort test
Measured: at 2 weeks
quality of sleep
measured by actigraphy
Measured: at baseline
Quadriceps muscle volume (optional)
with Magnetic resonance imaging
Measured: at 3 weeks
muscle dysfunction (optional)
measured by a Phosphorus 31 Nuclear magnetic resonance test
Measured: at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study startDec 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Why it stopped: Due to the health crisis and the lack of staff in the department no inclusion could be realized
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Saint-Etienne
- Responsible party
- Sponsor
- Investigators
- Jérome MOREL, MD PhD, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849326
- Sponsor's protocol ID
- 18CH175
- Other IDs
- 2018-A03511-54
- Acronym
- FatPostRéa
- Status last verified
- Apr 2023
- First submitted
- 19 Feb 2019
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Fatigue Etiology in Intensive Care Unit Survivors: the Role of Neuromuscular Function
- ClinicalTrials.gov ID
- NCT03849326
- Acronym / sponsor ID
- FatPostRéa / 18CH175
- Conditions
- Chronic Fatigue Syndrome, Intensive Care Unit, Muscle
- Keywords
- Neuromuscular function
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the health crisis and the lack of staff in the department no inclusion could be realized
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- University of Saint-Etienne
- Study start
- Dec 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuality of life Depression Physical pain Social provisions Quality of sleep | Other | "Fatigued" patients, "Non-fatigued" patients |
| blood testcomplete blood count and cytokine concentration | Biological | "Fatigued" patients, "Non-fatigued" patients |
| Maximal effort testThe maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory. | Other | "Fatigued" patients, "Non-fatigued" patients |
| actigraphyassessment of sleep quality | Device | "Fatigued" patients, "Non-fatigued" patients |
| 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) | Device | "Fatigued" patients, "Non-fatigued" patients |
Primary outcome
voluntary maximum force reduction
Time frame: at 2 weeks
6 secondary outcomes
Neuromuscular function : cortical activity
Time frame: at 2 weeks
Neuromuscular function : Peripheral function
Time frame: at visit 2
Maximal oxygen uptake (VO2max)
Time frame: at 2 weeks
quality of sleep
Time frame: at baseline
Quadriceps muscle volume (optional)
Time frame: at 3 weeks
muscle dysfunction (optional)
Time frame: at 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérome MOREL, MD PhD principal investigator
CHU de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires, blood test and Maximal effort test in people with Chronic Fatigue Syndrome and Intensive Care Unit, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
voluntary maximum force reduction (time frame: at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.