Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT04852718
Status:
UNKNOWN
Last Update Posted:
2021-04-21
First Post:
2021-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rehabilitation Program for the Sequelae of COVID 19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-20', 'studyFirstSubmitDate': '2021-04-15', 'studyFirstSubmitQcDate': '2021-04-20', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscular function', 'timeFrame': '1 year', 'description': 'Short Physical Performance Battery (SPPB) value 0-12'}], 'secondaryOutcomes': [{'measure': 'Health-related Quality of life', 'timeFrame': '1 year', 'description': 'SF36 questionnaire, vaule 0-100'}, {'measure': 'Respiratory muscle function', 'timeFrame': '1 year', 'description': 'Maximal inspiratory pressure (MIP) Maximal expiratory pressure (MEP)'}, {'measure': 'Exercise capacity', 'timeFrame': '1 year', 'description': 'Six-minute walking Test (6MWT): meters,'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '36112577', 'type': 'DERIVED', 'citation': 'Perrot JC, Segura M, Beranuy M, Gich I, Nadal MJ, Pintor A, Terra J, Ramirez E, Paz LD, Bascunana H, Plaza V, Guell-Rous MR. Comparison of post-COVID symptoms in patients with different severity profiles of the acute disease visited at a rehabilitation unit. PLoS One. 2022 Sep 16;17(9):e0274520. doi: 10.1371/journal.pone.0274520. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'SUBPROJECT 1:\n\nDescribe the situation of post-Covid patients in terms of muscle (skeletal and respiratory), cognitive, emotional and health-related quality of life in the 1st visit of the multidisciplinary post-covid rehabilitation consultation at the Hospital.\n\nRetrospective observational study. The data collected in clinical records during the first visit in the post-covid Rehabilitation consultation will be analysed.\n\nSUBPROJECT 2:\n\nEvaluate the response to a personalized rehabilitation program in patients with post-covid sequelae in terms of muscle (skeletal and respiratory), and health-related quality of life.\n\nProspective observational study of a single cohort of patients. The data will be collected from successive clinical visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '• Patients who were diagnosed with Covid-19 pneumonia, confirmed by serological tests or molecular biology test (PCR), and who were at home at the time of the 1st visit.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients who were diagnosed with Covid-19 pneumonia, confirmed by serological tests or molecular biology test (PCR), and who were at home at the time of the 1st visit.\n\n * PCR or serological negative test or more than 28 days after diagnosis.\n * Dyspnoea in activities of daily living (mMRC ≥ 2), (Annex 5 of the clinical protocol).\n * Patients who had muscle weakness (Clinical Frailty Scale ≥ 3), (Annex 1 of the clinical protocol).\n\nExclusion Criteria:\n\n* Patients with disease activity.\n* Live outside the reference area of the Hospital de la Santa Creu i Sant Pau.\n* Patients with cognitive impairment that makes it difficult to carry out the rehabilitation program.'}, 'identificationModule': {'nctId': 'NCT04852718', 'acronym': 'ISIS', 'briefTitle': 'Rehabilitation Program for the Sequelae of COVID 19 Infection', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Evaluate a Rehabilitation Program for the Sequelae of COVID 19 Infection: Description of a Clinical Practice', 'orgStudyIdInfo': {'id': 'IIBSP-COV-2020-155'}}, 'contactsLocationsModule': {'locations': [{'zip': '08041', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria-Rosa Güell-Rous, PhD', 'role': 'CONTACT', 'email': 'mguellr@santpau.cat', 'phone': '34935565972', 'phoneExt': '5964'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Maria-Rosa Güel-Rous, PhD', 'role': 'CONTACT', 'email': 'mguellr@santpau.cat', 'phone': '34935565972', 'phoneExt': '5964'}], 'overallOfficials': [{'name': 'Maria-Rosa Güel-Rous, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}