Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-29 @ 10:21 AM
Study NCT ID:
NCT01418768
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2011-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of an Inpatient Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD) III/IV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-01', 'studyFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2011-08-16', 'lastUpdatePostDateStruct': {'date': '2013-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in CAT-score', 'timeFrame': 'day 1 to day 21'}], 'secondaryOutcomes': [{'measure': 'Change in 6 minutes walking distance', 'timeFrame': 'day 1 to day 21'}, {'measure': 'Change in Short-Form 36', 'timeFrame': 'day 1 to day 21'}, {'measure': 'Change in Hospital Anxiety and Depression Scale', 'timeFrame': 'day 1 to day 21'}, {'measure': 'Change in diffusing capacity', 'timeFrame': 'day 1 to day 21'}, {'measure': 'Change in forced expiratory volume in 1 second (FEV1)', 'timeFrame': 'day 1 to day 21'}, {'measure': 'Change in Body Mass index', 'timeFrame': 'day 1 to day 21'}, {'measure': 'Change in basal energy rate', 'timeFrame': 'day 1 to day 21'}, {'measure': 'Change in BODE-Index', 'timeFrame': 'day 1 to day 21'}, {'measure': "Change in St. George's Respiratory Questionaire", 'timeFrame': 'Day 1 to day 21'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'CAT', 'Rehabilitation', 'chronic obstructive pulmonary disease GOLD III/IV'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if there is a change in the CAT-score after an inpatient rehabilitation of three weeks and if it correlates with other common parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* inpatient rehabilitation in Schön Klinik Berchtesgadener Land\n* stable COPD(GOLD severity III and IV with and without respiratory insufficiency)\n\nExclusion Criteria:\n\n* severe exacerbation in the last four weeks\n* acute coronary syndrome\n* unability to cooperate'}, 'identificationModule': {'nctId': 'NCT01418768', 'briefTitle': 'Effects of an Inpatient Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD) III/IV', 'organization': {'class': 'OTHER', 'fullName': 'Schön Klinik Berchtesgadener Land'}, 'orgStudyIdInfo': {'id': 'CAT2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehabilitation', 'interventionNames': ['Other: inpatient rehabiliation']}], 'interventions': [{'name': 'inpatient rehabiliation', 'type': 'OTHER', 'description': 'inpatient, multimodal, individual workout including endurance training, strength training, coordination training etc. for three weeks.', 'armGroupLabels': ['Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83471', 'city': 'Schönau am Königssee', 'country': 'Germany', 'facility': 'Schön Klinik Berchtesgadener Land', 'geoPoint': {'lat': 47.60055, 'lon': 12.98704}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schön Klinik Berchtesgadener Land', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head physician pneumology', 'investigatorFullName': 'Klaus Kenn', 'investigatorAffiliation': 'Schön Klinik Berchtesgadener Land'}}}}