Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-27 @ 1:11 PM
Study NCT ID:
NCT00388466
Status:
COMPLETED
Last Update Posted:
2006-10-16
First Post:
2006-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Body Vibration - a New Therapeutic Approach to Improve Muscle Function in CF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'completionDateStruct': {'date': '2006-08'}, 'lastUpdateSubmitDate': '2006-10-13', 'studyFirstSubmitDate': '2006-10-13', 'studyFirstSubmitQcDate': '2006-10-13', 'lastUpdatePostDateStruct': {'date': '2006-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'muscle force at the beginning of the study and after 3 months'}, {'measure': 'muscle power at the beginning of the study and after 3 months'}], 'secondaryOutcomes': [{'measure': 'pulmonary function testing at the beginning of the study and after 3 months'}]}, 'conditionsModule': {'keywords': ['whole body vibration', 'muscle function', 'cystic fibrosis', 'mechanography', 'chair-rising-test'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '16327004', 'type': 'BACKGROUND', 'citation': 'Fricke O, Weidler J, Tutlewski B, Schoenau E. Mechanography--a new device for the assessment of muscle function in pediatrics. Pediatr Res. 2006 Jan;59(1):46-9. doi: 10.1203/01.pdr.0000191580.07644.1c. Epub 2005 Dec 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of whole body vibration (WBV) on muscle function in adult CF-patients.', 'detailedDescription': 'Cystic Fibrosis (CF) is the most common chronic hereditary disease in Caucasians. Due to improved therapy and better understanding of the disease, life expectancy has risen to an average of 38 years and is continuing to rise. With the increased life-expectancy it becomes even more important to maintain functional activity as part of quality of life. Mechanical stimulation in form of whole body vibration (WBV) is a new type of exercise currently tested in sports, geriatrics and rehabilitation. It has recently been found to be a safe and efficient method to activate muscular activity via stretch reflexes leading to improvement of muscular performance, body balance and physical functioning.\n\n10 patients of the CF Center Cologne, Germany, took part in the Galileo study. They were provided by the vibrating platform (Galileo 2000)for whole body vibration training at home. The patients were standing in an upright position receiving vertical vibration of frequencies between 20-25 Hz. This vibration exercise evokes muscle contractions via stretch reflexes improving muscular activity. The training schedule consisted of three 3-minute sessions twice a day 5 days per week for 3 months.\n\nEvery 4 weeks the patients were seen for assessment of muscle function to evaluate the effects of this new intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of Cystic Fibrosis\n* age older than 18 years\n\nExclusion Criteria:\n\n* hypersplenic syndrome\n* acute arthritis or osteomyelitis'}, 'identificationModule': {'nctId': 'NCT00388466', 'briefTitle': 'Whole Body Vibration - a New Therapeutic Approach to Improve Muscle Function in CF', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Cystic Fibrosis: Improvement of Muscle Force and Function by Whole Body Vibration Exercise', 'orgStudyIdInfo': {'id': '05-005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GALILEO', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'facility': "CF Center Cologne, University Children's Hospital", 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Eckhard Schoenau, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Children´s Hospital Cologne, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}}}}