Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-30 @ 5:26 AM
Study NCT ID:
NCT04363606
Status:
TERMINATED
Last Update Posted:
2025-03-25
First Post:
2020-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Fatigue Etiology and Recovery in Covid-19 Patients: the Role of Fatigability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D056044', 'term': 'Actigraphy'}, {'id': 'D009780', 'term': 'Occult Blood'}, {'id': 'D015930', 'term': 'Diet Records'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D061725', 'term': 'Accelerometry'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'whyStopped': 'under-inclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2020-04-24', 'studyFirstSubmitQcDate': '2020-04-24', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'voluntary maximum force reduction', 'timeFrame': '6 weeks post-discharge'}], 'secondaryOutcomes': [{'measure': 'Neuromuscular function : cortical activity', 'timeFrame': '6 weeks post-discharge', 'description': 'Level of cortical activation and cortico-spinal excitability measured by transcranial magnetic stimulation'}, {'measure': 'Neuromuscular function : Peripheral function', 'timeFrame': '6 weeks post-discharge', 'description': 'Peripheral function by electrical nerve stimulation'}, {'measure': 'Maximal oxygen uptake (VO2max)', 'timeFrame': '6 weeks post-discharge', 'description': 'measured by effort test'}, {'measure': 'quality of sleep', 'timeFrame': '6 weeks post-discharge', 'description': 'measured by actigraphy'}, {'measure': 'muscle volume', 'timeFrame': '6 weeks post-discharge', 'description': 'with Magnetic resonance imaging'}, {'measure': 'metabolic fatigue', 'timeFrame': '6 weeks post-discharge', 'description': 'measured by a Phosphorus 31 Nuclear magnetic resonance test'}, {'measure': 'microbiote intestinal', 'timeFrame': 'baseline and 6 months', 'description': 'stool analysis (concerns only the patients of Saint Etienne)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuromuscular function', 'Fatigability'], 'conditions': ['Chronic Fatigue Syndrome', 'Intensive Care Unit', 'Muscle']}, 'referencesModule': {'references': [{'pmid': '38742855', 'type': 'DERIVED', 'citation': 'Kennouche D, Foschia C, Brownstein CG, Lapole T, Rimaud D, Royer N, LE Mat F, Thiery G, Gauthier V, Giraux P, Oujamaa L, Sorg M, Verges S, Doutreleau S, Marillier M, Prudent M, Bitker L, Feasson L, Gergele L, Stauffer E, Guichon C, Gondin J, Morel J, Millet GY. Factors Associated with Fatigue in COVID-19 ICU Survivors. Med Sci Sports Exerc. 2024 Sep 1;56(9):1563-1573. doi: 10.1249/MSS.0000000000003455. Epub 2024 Apr 14.'}]}, 'descriptionModule': {'briefSummary': '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 symptom seems particularly pronounced in Covid-19 patients and may affect their quality of life by decreasing their capacity to perform simple tasks of daily life.\n\nThe aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in the feeling of fatigue of Covid-19 patients. 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 and its recovery will allow to optimize rehabilitation treatments to shorten the persistence of chronic fatigue and in fine improve life quality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for patients who have been in intensive care :\n\n* Diagnosed with Covid-19\n* Ventilated in ICU for at least 3 consecutive days\n* ICU discharge between 4 and 8 weeks\n* Approval received from a physician\n* Command of the French language\n\nInclusion Criteria for patients who have NOT been in intensive care :\n\n* Diagnosed with Covid-19 : positive serological test or positive PCR test following nasopharyngeal swabbing\n* Approval received from a physician\n* Command of the French language\n\nExclusion Criteria:\n\n* Taking neuroactive substances that can alter corticospinal excitability\n* Patients with co-morbidities leading to significant fatigue: e.g. cancerous pathologies, sleep apnea\n* Patients with neurodegenerative or neuromuscular disease\n* Contraindication to the application of a magnetic field\n* Contraindication to the practice of Magnetic Resonance Imaging\n* Participant is pregnant\n* Patients with psychiatric disorders\n* Paraplegic and hemiplegic patients\n* Addictive disorders'}, 'identificationModule': {'nctId': 'NCT04363606', 'acronym': 'FatCovid-19', 'briefTitle': 'Chronic Fatigue Etiology and Recovery in Covid-19 Patients: the Role of Fatigability', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Chronic Fatigue Etiology and Recovery in Covid-19 Patients : the Role of Fatigability and Stay in Intensive Care', 'orgStudyIdInfo': {'id': '20CH085'}, 'secondaryIdInfos': [{'id': '2020-A00982-37', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"Non-fatigued" patients who have been in intensive care units', 'interventionNames': ['Other: Questionnaires', 'Biological: blood test', 'Other: Maximal effort test', 'Device: actigraphy', 'Device: Neuromuscular evaluation', 'Other: stool analysis', 'Other: food diary']}, {'type': 'EXPERIMENTAL', 'label': '"Fatigued" patients who have been in intensive care units', 'interventionNames': ['Other: Questionnaires', 'Biological: blood test', 'Other: Maximal effort test', 'Device: actigraphy', 'Device: Neuromuscular evaluation', 'Other: stool analysis', 'Other: food diary']}, {'type': 'EXPERIMENTAL', 'label': 'patients who have not been in intensive care units', 'interventionNames': ['Other: Questionnaires', 'Biological: blood test', 'Other: Maximal effort test', 'Device: actigraphy', 'Device: Neuromuscular evaluation', 'Other: stool analysis', 'Other: food diary']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Quality of life Depression Physical pain Social provisions Quality of sleep', 'armGroupLabels': ['"Fatigued" patients who have been in intensive care units', '"Non-fatigued" patients who have been in intensive care units', 'patients who have not been in intensive care units']}, {'name': 'blood test', 'type': 'BIOLOGICAL', 'description': 'complete blood count and cytokine concentration, TNF-alpha, LDL oxidized, AOPP, SOD, GPX, catalase, albumin, transthyretin, RBP, transferin, α-1 glycoprotein acide, ferritine, selenium, zinc, magnesium', 'armGroupLabels': ['"Fatigued" patients who have been in intensive care units', '"Non-fatigued" patients who have been in intensive care units', 'patients who have not been in intensive care units']}, {'name': 'Maximal effort test', 'type': 'OTHER', 'description': 'The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.', 'armGroupLabels': ['"Fatigued" patients who have been in intensive care units', '"Non-fatigued" patients who have been in intensive care units', 'patients who have not been in intensive care units']}, {'name': 'actigraphy', 'type': 'DEVICE', 'description': 'assessment of sleep quality', 'armGroupLabels': ['"Fatigued" patients who have been in intensive care units', '"Non-fatigued" patients who have been in intensive care units', 'patients who have not been in intensive care units']}, {'name': 'Neuromuscular evaluation', 'type': 'DEVICE', 'description': '* The maximum isometric force produced by the knee extensors will be measured on the ergometer\n* the intensity of muscular electrical activity recorded by surface electromyography\n* Peripheral nerve stimulation\n* Transcranial magnetic stimulation\n* Magnetic resonance imaging', 'armGroupLabels': ['"Fatigued" patients who have been in intensive care units', '"Non-fatigued" patients who have been in intensive care units', 'patients who have not been in intensive care units']}, {'name': 'stool analysis', 'type': 'OTHER', 'description': 'analyze the composition of the intestinal microbiote. concerns only the patients of Saint Etienne', 'armGroupLabels': ['"Fatigued" patients who have been in intensive care units', '"Non-fatigued" patients who have been in intensive care units', 'patients who have not been in intensive care units']}, {'name': 'food diary', 'type': 'OTHER', 'description': '3 days of information to determine nutrient intakes. concerns only the patients of Saint Etienne', 'armGroupLabels': ['"Fatigued" patients who have been in intensive care units', '"Non-fatigued" patients who have been in intensive care units', 'patients who have not been in intensive care units']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Clinique de la Sauvegarde - Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Croix Rousse - HCL', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier de Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Hôpital privé de la Loire', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '42100', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Clinique Mutualiste Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '69230', 'city': 'Saint-Genis-Laval', 'country': 'France', 'facility': 'Hôpital Henry Gabrielle', 'geoPoint': {'lat': 45.69542, 'lon': 4.79316}}], 'overallOfficials': [{'name': 'Jérome MOREL, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Saint-Etienne', 'class': 'UNKNOWN'}, {'name': "Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}