Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-02-21 @ 2:12 AM
Study NCT ID:
NCT04184193
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2019-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefits of Pulmonary Rehabilitation in Patients With Severe Lymphangioleiomyomatosis (LAM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018192', 'term': 'Lymphangioleiomyomatosis'}], 'ancestors': [{'id': 'D008203', 'term': 'Lymphangiomyoma'}, {'id': 'D018190', 'term': 'Neoplasm, Lymphatic Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D054973', 'term': 'Perivascular Epithelioid Cell Neoplasms'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-16', 'studyFirstSubmitDate': '2019-11-11', 'studyFirstSubmitQcDate': '2019-12-02', 'lastUpdatePostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline 6 Minute walk distance at week 4', 'timeFrame': 'baseline and week 4', 'description': 'the walked distance in meter will be the Primary outcome of the 6 Minute walk test'}, {'measure': 'Change from baseline Quality of life at week 4', 'timeFrame': 'baseline and week 4', 'description': 'the physical and mental health component summary score from the Short Form 36 Health Questionnaire will be recorded. Score range from 0 to 100 with lower scores indicating worse impairment'}], 'secondaryOutcomes': [{'measure': 'Change from baseline lung function at week 4', 'timeFrame': 'baseline and week 4', 'description': 'forced expiratory volume in 1 second and inspiratory vital capacity will be provided in Liter and percent predicted'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphangioleiomyomatosis', 'LAM', 'Pulmonary Rehabilitation']}, 'referencesModule': {'references': [{'pmid': '32962746', 'type': 'DERIVED', 'citation': 'Gloeckl R, Nell C, Schneeberger T, Jarosch I, Boensch M, Watz H, Wirtz H, Welte T, Kenn K, Koczulla AR. Benefits of pulmonary rehabilitation in patients with advanced lymphangioleiomyomatosis (LAM) compared with COPD - a retrospective analysis. Orphanet J Rare Dis. 2020 Sep 22;15(1):255. doi: 10.1186/s13023-020-01540-3.'}]}, 'descriptionModule': {'briefSummary': 'Data from patients with the orphan disease of lymphangioleiomyomatosis (LAM) which performed a pulmonary Rehabilitation program will be analyzed retrospectively. Data will be taken from the internal data base of the reference Center (Schoen Klinik Berchtesgadener Land, Schoenau, Germany) where These data were collected during clinical routine. Data will be included from the year 2000 until now. A retrospectively matched COPD cohort will be included for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with a confirmed diagnosis of Lymphangioleiomyomatosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed diagnosis of Lymphangioleiomyomatosis\n* performed a pulmonary Rehabilitation program at the reference center\n\nExclusion Criteria:\n\n* missing data\n* repeated stay for pulmonary Rehabilitation at the reference center'}, 'identificationModule': {'nctId': 'NCT04184193', 'briefTitle': 'Benefits of Pulmonary Rehabilitation in Patients With Severe Lymphangioleiomyomatosis (LAM)', 'organization': {'class': 'OTHER', 'fullName': 'Schön Klinik Berchtesgadener Land'}, 'officialTitle': 'Benefits of Pulmonary Rehabilitation in Patients With Severe Lymphangioleiomyomatosis (LAM) - a Retrospective Analysis', 'orgStudyIdInfo': {'id': 'LAM Trial'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonary Rehabilitation', 'interventionNames': ['Other: Pulmonary Rehabilitation']}], 'interventions': [{'name': 'Pulmonary Rehabilitation', 'type': 'OTHER', 'description': 'Patients will perform a comprehensive, inpatient pulmonary rehabilitation program for 4 weeks duration', 'armGroupLabels': ['Pulmonary Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Schönau am Königssee', 'country': 'Germany', 'facility': 'Schoen Klinik Berchtesgadener Land', 'geoPoint': {'lat': 47.60055, 'lon': 12.98704}}], 'overallOfficials': [{'name': 'Rembert A Koczulla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schoen Klinik Berchtesgadener Land'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schön Klinik Berchtesgadener Land', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Klaus Kenn', 'investigatorAffiliation': 'Schön Klinik Berchtesgadener Land'}}}}