Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-25 @ 5:42 PM
Study NCT ID:
NCT01772667
Status:
COMPLETED
Last Update Posted:
2020-09-04
First Post:
2013-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Effects of an Inpatient Pulmonary Rehabilitation Program in Patients With Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2013-01-17', 'studyFirstSubmitQcDate': '2013-01-18', 'lastUpdatePostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delta of 6-minute walking distance from 1 week pre rehabilitation to 3 month post rehabilitation', 'timeFrame': '1 week before rehabilitation to 3 month after finishing rehabilitation'}], 'secondaryOutcomes': [{'measure': 'Delta of physical activity level from 1 week pre rehabilitation to 3 month post rehabilitation', 'timeFrame': '1 week before rehabilitation to 3 month after finishing rehabilitation'}, {'measure': 'Delta of SF36-score (questionnaire to measure quality of life) from 1 week pre to 3 month post rehabilitation', 'timeFrame': '1 week before rehabilitation to 3 month after finishing rehabilitation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pulmonary fibrosis', 'interstitial lung disease', 'pulmonary rehabilitation', 'exercise capacity', 'physical activity', 'quality of life'], 'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'There is evidence that an inpatient pulmonary rehabilitation of 3 weeks improves exercise capacity and quality of life in patients with idiopathic pulmonary fibrosis. However, there are no data available regarding long-term effects of this multimodal program. The aim of this study is to investigate the long-term impact of a rehabilitation program 3 month after finishing on exercise capacity and physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* want to start a rehabilitation program in "Schoen Klinik Berchtesgadener Land"\n* patients with idiopathic pulmonary fibrosis (vital capacity \\> 50% pred.)\n\nExclusion Criteria:\n\n* exacerbation in the last 4 weeks'}, 'identificationModule': {'nctId': 'NCT01772667', 'briefTitle': 'Long Term Effects of an Inpatient Pulmonary Rehabilitation Program in Patients With Pulmonary Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Schön Klinik Berchtesgadener Land'}, 'officialTitle': 'Long Term Effects of a 3-week Inpatient Pulmonary Rehabilitation Program in Patients With Idiopathic Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'Fibrosis2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual care during the whole study period without pulmonary rehabilitation. The patients will perform their normal daily life.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Inpatient Rehabilitation', 'description': '3-week inpatient multimodal pulmonary rehabilitation program, including daily exercise training, breathing therapy, medical treatment and psychological support. In the following 3 month, the patients will perform their normal daily life.', 'interventionNames': ['Procedure: Inpatient Rehabilitation']}], 'interventions': [{'name': 'Inpatient Rehabilitation', 'type': 'PROCEDURE', 'description': 'Rehabilitation program in "Schoen Klinik Berchtesgadener Land"', 'armGroupLabels': ['Inpatient Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83471', 'city': 'Schönau am Königssee', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Schoen Klinik Berchtesgadener Land', 'geoPoint': {'lat': 47.60055, 'lon': 12.98704}}], 'overallOfficials': [{'name': 'Klaus Kenn, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head physician in the department of pulmology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schön Klinik Berchtesgadener Land', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head physician of the Department of Pulmology', 'investigatorFullName': 'Klaus Kenn', 'investigatorAffiliation': 'Schön Klinik Berchtesgadener Land'}}}}