Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 1:14 PM
Study NCT ID:
NCT01480960
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2011-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Whole Body Vibration Training in Patients After Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2011-11-24', 'studyFirstSubmitQcDate': '2011-11-24', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in 6-minute walking distance', 'timeFrame': 'change from baseline to day 21'}], 'secondaryOutcomes': [{'measure': 'change in Wmax', 'timeFrame': 'change from baseline to day 21', 'description': 'maximum workload in incremental cycling test'}, {'measure': 'change in Fmax', 'timeFrame': 'change from baseline to day 21', 'description': 'maximum isometric quadriceps force'}, {'measure': 'change in fibre cross sectional area', 'timeFrame': 'change from baseline to day 21', 'description': 'cross sectional area of the M.rectus femoris, measured by ultrasound'}, {'measure': 'change in chair rise time', 'timeFrame': 'change from baseline to day 21', 'description': 'chair rise test: to get from a sitting position to a standing, measuring the time for 5 repetitions'}, {'measure': 'change in quality of life', 'timeFrame': 'change from baseline to day 21', 'description': 'SF-36 questionnaire and CRQ questionnaire'}, {'measure': 'change in body cell mass', 'timeFrame': 'change from baseline to day 21', 'description': 'measured by bio-impedance analysis'}, {'measure': 'change in IGF-1', 'timeFrame': 'change from baseline to day 21', 'description': 'IGF-1, measured in a blood sample'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lung transplantation', 'whole body vibration', 'exercise training', 'pulmonary rehabilitation'], 'conditions': ['Patients Following Lung Transplantation (Single and Double)']}, 'referencesModule': {'references': [{'pmid': '34282853', 'type': 'DERIVED', 'citation': 'Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients following lung transplantation. Exercise training has been shown to be a cornerstone of an inpatient rehabilitation program to reduce muscle dysfunction and improve exercise performance. In our study we will investigate the benefit of a whole body vibration training in addition to a standard pulmonary rehabilitation program that includes endurance and strength training. We will include a total of 140 patients (70 patients \\< 1 year after lung Transplantation and 70 patients \\> 1 year after lung Transplantation). Our hypothesis is that an addtitional whole body vibration training produces a greater benefit to exercise capacity in lung transplantat patients (LTx).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participation in an inpatient rehabilitation program\n* double or single lung transplantation due to chronic obstructive pulmonary disease, Alpha-1-antitrypsine deficiency, interstitial lung disease\n\nExclusion Criteria:\n\n* severe exacerbation in the last 4 weeks with the necessity of delivering antibiotics/ corticosteroids\n* non-compliance'}, 'identificationModule': {'nctId': 'NCT01480960', 'briefTitle': 'Effects of a Whole Body Vibration Training in Patients After Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Schön Klinik Berchtesgadener Land'}, 'officialTitle': 'Effects of a Whole Body Vibration Training on the Exercise Performance in Patients After Lung Transplantation', 'orgStudyIdInfo': {'id': 'LTX2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Whole body vibration training', 'description': 'Whole body vibration training in addition to pulmonary rehabilitation', 'interventionNames': ['Other: Pulmonary rehabilitation + whole body vibration training']}, {'type': 'NO_INTERVENTION', 'label': 'No whole body vibration training', 'description': 'Pulmonary rehabilitation without whole body vibration training'}], 'interventions': [{'name': 'Pulmonary rehabilitation + whole body vibration training', 'type': 'OTHER', 'otherNames': ['Galileo training'], 'description': 'standard inpatient rehabilitation program including endurance and strength plus squats on a vibration plate for 4x2 minutes, 3 times per week', 'armGroupLabels': ['Whole body vibration training']}]}, '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': 'Dr. med. Klaus Kenn, Head physician', 'investigatorFullName': 'Klaus Kenn', 'investigatorAffiliation': 'Schön Klinik Berchtesgadener Land'}}}}