Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-01-01 @ 2:04 AM
Study NCT ID:
NCT04896905
Status:
COMPLETED
Last Update Posted:
2021-05-21
First Post:
2021-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation After Covid19-Clinical Results and Predictive Factors
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-20', 'studyFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2021-05-20', 'lastUpdatePostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mobility', 'timeFrame': 'Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)', 'description': 'Timed Up and Go-Test TUG (Seconds; less=better, normal \\<10 Sec.)'}, {'measure': 'Functional Independence Measurement-Level (FIM)', 'timeFrame': 'Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)', 'description': 'FIM at entry and discharge (min 18, max 126 points; higher level= better functioning; )'}, {'measure': 'Promis-10 (Promis= Patient reported outcome measurement information system)', 'timeFrame': 'Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)', 'description': 'Level of patient self rated functioning in daily activities (higher level= better self related functioning)'}, {'measure': 'Quality of life', 'timeFrame': 'Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)', 'description': 'EQ5D- VAS (0-100; higher level = better quality of life)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid19', 'Sars-CoV-2', 'Rehabilitation', 'Outcome', 'Predictive factors'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to gain insight into the rehabilitation process and predictive factors for the outcome after rehabilitation in three patient groups:\n\n1. SARS-CoV-2-positive patients in the isolation ward\n2. Post-Covid-19 patients\n3. Control group; matched for gender, age and co-morbidity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients referred to rehabilitation between March and June 2020 either with active Covid19, post-Covid-State oor other indications for inpatient rehab (eg. muskuloskelettal, cancer, pulmonary diseases not related to Covid19)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients assigned to rehab\n* Written informed consent\n\nExclusion Criteria:\n\n* not able to fill in questionnaires in German'}, 'identificationModule': {'nctId': 'NCT04896905', 'briefTitle': 'Rehabilitation After Covid19-Clinical Results and Predictive Factors', 'organization': {'class': 'OTHER', 'fullName': 'Klinik Valens'}, 'officialTitle': 'Rehabilitation After Covid19-Clinical Results and Predictive Factors for Rehabilitation Outcomes', 'orgStudyIdInfo': {'id': 'Covid19_2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Isolation group with active Covid19', 'description': 'Patients assigned to rehab which had to be treated in isolation wards dur to active disease', 'interventionNames': ['Other: Rehabilitation']}, {'label': 'Post-Covid-group', 'description': 'Patients assigned to rehab after active disease, still having restrictions in activity and particiaption', 'interventionNames': ['Other: Rehabilitation']}, {'label': 'Control group', 'description': 'Pateints assigned to rehabilitation in the same time period without any signs of Sars-coV-2 infection', 'interventionNames': ['Other: Rehabilitation']}], 'interventions': [{'name': 'Rehabilitation', 'type': 'OTHER', 'description': 'Rehabilitative procedures in isolation ward', 'armGroupLabels': ['Control group', 'Isolation group with active Covid19', 'Post-Covid-group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH- 7317', 'city': 'Valens', 'state': 'Canton of St. Gallen', 'country': 'Switzerland', 'facility': 'Rehabilitationszentrum Klinik Valens', 'geoPoint': {'lat': 46.96658, 'lon': 9.47705}}], 'overallOfficials': [{'name': 'Steffi Petzold, MMed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kliniken Valens'}, {'name': 'Roisin Carney, PT, cand MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kliniken Valens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinik Valens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Medical Officer, Clinical Professor', 'investigatorFullName': 'Stefan Bachmann', 'investigatorAffiliation': 'Klinik Valens'}}}}