Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT05855356
Status:
UNKNOWN
Last Update Posted:
2023-05-11
First Post:
2023-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Covid-19 Dysautonomia Rehabilitation Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'unblinded randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-03-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2023-05-08', 'studyFirstSubmitQcDate': '2023-05-09', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with lack of definite Dysautonomia Diagnosis', 'timeFrame': '4 months', 'description': 'Ewing Battery is a validated instrument to diagnose dysautonomia, with a definite diagnosis when 2 out of 4 heart rate tests are abnormal'}, {'measure': 'Compliance, Adverse Events and Protocol Titration to examine feasibility of the trial', 'timeFrame': '4 months', 'description': 'Process measures that will substantiate offering of the service'}], 'secondaryOutcomes': [{'measure': '10 minutes NASA Lean Test', 'timeFrame': 'checked at [0], [8] and [16] weeks', 'description': 'Validated measure to record orthostatic intolerance, recording of blood pressure and heart rate in 5 min supine position, and every minute when standing up till 10 min'}, {'measure': 'Six minute Walk Test', 'timeFrame': 'checked at [0], [8] and [16] weeks', 'description': 'Validated measure, a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.'}, {'measure': '1 minute sit to stand test', 'timeFrame': 'checked at [0], [8] and [16] weeks', 'description': 'Validated measure to record the times standing up from a chair, closely related with cardiorespiratory capacity and lower limb strength'}, {'measure': 'Fatigue Severity Scale', 'timeFrame': 'checked at [0], [8] and [16] weeks', 'description': 'Validated measure to record fatigue severity as reported by the patient, 9 statements each in a scale of 1-7, min 9 max 63'}, {'measure': 'modified Medical Research Council Dyspnea Scale', 'timeFrame': 'checked at [0], [8] and [16] weeks', 'description': 'Validated measure to record functional disability because of dyspnea as reported by the patient in a scale 0-4'}, {'measure': 'Nijmegen Questionnaire', 'timeFrame': 'checked at [0], [8] and [16] weeks', 'description': 'Validated measure to record dysfunctional breathing as recorded by the patient with each statement valued 0-4, with A score of over 23 out of 64 suggest a positive diagnosis of hyperventilation syndrome.'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': 'checked at [0], [8] and [16] weeks', 'description': 'Validated measure for rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation, with a normal score over 25/30'}, {'measure': 'International Physical Activity Questionnaire', 'timeFrame': 'checked at [0], [8] and [16] weeks', 'description': 'Validated measure with 27 item self reporting physical activity of the patient'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'checked at [0], [8] and [16] weeks', 'description': 'Validated measure, a 14-item measure designed to assess anxiety and depression symptoms in medical patients. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case'}, {'measure': 'EuroQoL 5 Dimensions 5 Levels', 'timeFrame': 'checked at [0], [8] and [16] weeks', 'description': 'Validated measure, a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression'}, {'measure': 'Cardiorespiratory exercise test', 'timeFrame': 'checked at [0], [8] and [16] weeks', 'description': 'A specialized type of stress test or exercise test that measures exercise ability'}, {'measure': 'Lower Extremity Strength', 'timeFrame': 'checked at [0], [8] and [16] weeks', 'description': 'Assessment of lower extremity strength using a dynamometer.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Long Covid', 'Post Covid-19 condition', 'Rehabilitation'], 'conditions': ['Post-Acute COVID-19 Syndrome', 'Dysautonomia']}, 'referencesModule': {'references': [{'pmid': '35853576', 'type': 'BACKGROUND', 'citation': 'Ormiston CK, Swiatkiewicz I, Taub PR. Postural orthostatic tachycardia syndrome as a sequela of COVID-19. Heart Rhythm. 2022 Nov;19(11):1880-1889. doi: 10.1016/j.hrthm.2022.07.014. Epub 2022 Jul 16.'}, {'pmid': '32145864', 'type': 'BACKGROUND', 'citation': 'Raj SR, Guzman JC, Harvey P, Richer L, Schondorf R, Seifer C, Thibodeau-Jarry N, Sheldon RS. Canadian Cardiovascular Society Position Statement on Postural Orthostatic Tachycardia Syndrome (POTS) and Related Disorders of Chronic Orthostatic Intolerance. Can J Cardiol. 2020 Mar;36(3):357-372. doi: 10.1016/j.cjca.2019.12.024.'}, {'pmid': '35743774', 'type': 'BACKGROUND', 'citation': 'Katsarou MS, Iasonidou E, Osarogue A, Kalafatis E, Stefanatou M, Pappa S, Gatzonis S, Verentzioti A, Gounopoulos P, Demponeras C, Konstantinidou E, Drakoulis N, Asimakos A, Antonoglou A, Mavronasou A, Spetsioti S, Kotanidou A, Katsaounou P. The Greek Collaborative Long COVID Study: Non-Hospitalized and Hospitalized Patients Share Similar Symptom Patterns. J Pers Med. 2022 Jun 17;12(6):987. doi: 10.3390/jpm12060987.'}]}, 'descriptionModule': {'briefSummary': 'Dysautonomia in post-covid-19 condition appears to affect a significant number of patients, with reports raising the incidence up to 61%, having an overlap with myalgic encephalomyelitis/ chronic fatigue syndrome. Quality of life and daily function is significantly impacted and conservative management interventions, despite the lack of high quality evidence up to now, are needed to ameliorate disability. 50 adults with a dysautonomia post-covid-19 diagnosis based on the Ewing battery and a NASA lean test will be enrolled in a randomized single blinded controlled trial with a crossover design. Feasibility and lack of definite dysautonomia diagnosis will be the primary out-comes, while secondary outcomes will be health-related, clinical and cardiopulmonary exercise test indicators. Safety and acceptance will also be checked, primarily excluding participants with post exertional malaise. The Long-CoViD patients Causal Diagnosis and Rehabilitation study in patients with Dysautonomia (LoCoDiRE-Dys) study intervention will consist of an educational module, breathing retraining and an individualized exercise intervention of biweekly sessions for two months with regular assessment of both groups. LoCoDiRe- Dys aims to be the first post-covid-19 randomized study in people with dysautonomia offering a multimodal intervention both in diagnosis and management'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18-65 years of age\n* WHO definition of post covid-19 condition\n* Confirmed dysautonomia diagnosis through Ewing Battery\n* Able to attend 2 times/ week for 8 weeks\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Absolute or relative contra-indications to exercise due to cardiac pathology\n* Serious mental/ cognitive impairment that will not allow systematic participation\n* Unable to regularly reach the center\n* Pregnancy\n* CFS/ME fulfilling the Canadian Consensus Criteria\n* Secondary health conditions that would explain symptoms, intervene in dysautonomia diagnosis or would impede participation in the exercise protocol (i.e. , untreated hypothyroidism and Diabetes Melitus, major psychiatric disorders, COPD, PICS, Pulmonary Fibrosis, chronic respiratory or heart failure, not ambulatory, suffering from dementia, chronically paralyzed, with paraplegia, with multiple injuries or other serious orthopedic problems that caused disability, patients suffering from very serious underlying diseases such as end-stage cancer, and those with neurological diseases causing disability)'}, 'identificationModule': {'nctId': 'NCT05855356', 'acronym': 'LoCoDiRe-Dys', 'briefTitle': 'Post Covid-19 Dysautonomia Rehabilitation Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Evangelismos Hospital'}, 'officialTitle': 'The Long-CoviD Patients Causal Diagnosis and Rehabilitation Randomized Feasibility Controlled Trial in Patients With Dysautonomia: the LoCoDiRe-Dys Study', 'orgStudyIdInfo': {'id': '22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LoCoDiRe-Dys', 'description': 'Respiratory physiotherapy, personalized aerobic and strength training in parallel with standard of care', 'interventionNames': ['Procedure: Rehabilitation', 'Procedure: Standard of Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Standard of care including behavioural and medical advice', 'interventionNames': ['Procedure: Standard of Care']}], 'interventions': [{'name': 'Rehabilitation', 'type': 'PROCEDURE', 'description': 'respiratory physiotherapy, personalized aerobic and strength training', 'armGroupLabels': ['LoCoDiRe-Dys']}, {'name': 'Standard of Care', 'type': 'PROCEDURE', 'description': 'Behavioural and Medical management', 'armGroupLabels': ['LoCoDiRe-Dys', 'Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '106 76', 'city': 'Athens', 'state': 'Attica', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Paraskevi Katsaounou, PhD', 'role': 'CONTACT', 'email': 'paraskevikatsaounou@gmail.com'}, {'name': 'Andreas Assimakos, PhD', 'role': 'CONTACT', 'email': 'silverakos@gmail.com'}], 'facility': 'First Department of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, National and Kapodistrian University of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Antonios Kontaxakis', 'role': 'CONTACT', 'email': 'akontaxakis@yahoo.gr', 'phone': '+306947468724'}, {'name': 'Dimitrios Spaggoulakis', 'role': 'CONTACT', 'email': 'dimitrisspglks@gmail.com'}], 'overallOfficials': [{'name': 'Paraskevi Katsaounou', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director of the Lond Covid Outpatient Clinic'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '3 months after completion of the study, for 5 years on', 'ipdSharing': 'YES', 'description': 'Anonymized clinical data', 'accessCriteria': 'Request reasons clearly stated- Sharing of further analysis plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evangelismos Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, {'name': 'LONG COVID GREECE', 'class': 'UNKNOWN'}, {'name': '414 Military Hospital of Special Diseases', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PM&R Consultant', 'investigatorFullName': 'Antonios Kontaxakis', 'investigatorAffiliation': 'Evangelismos Hospital'}}}}