Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-01 @ 10:36 AM
Study NCT ID:
NCT00432692
Status:
COMPLETED
Last Update Posted:
2010-02-25
First Post:
2007-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Falls Prevention in Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-24', 'studyFirstSubmitDate': '2007-02-07', 'studyFirstSubmitQcDate': '2007-02-07', 'lastUpdatePostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fall incidence, which is measured by monthly fall registration cards'}], 'secondaryOutcomes': [{'measure': 'Obstacle avoidance performance'}, {'measure': 'Fear of falling (ABC)'}, {'measure': 'Activity level (LAPAQ)'}]}, 'conditionsModule': {'keywords': ['osteoporosis', 'falls', 'prevention', 'elderly', 'exercise', 'incidence', 'obstacle avoidance'], 'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '21044715', 'type': 'DERIVED', 'citation': 'Smulders E, Weerdesteyn V, Groen BE, Duysens J, Eijsbouts A, Laan R, van Lankveld W. Efficacy of a short multidisciplinary falls prevention program for elderly persons with osteoporosis and a fall history: a randomized controlled trial. Arch Phys Med Rehabil. 2010 Nov;91(11):1705-11. doi: 10.1016/j.apmr.2010.08.004.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine wether a falls prevention program can reduce fall incidence in people with osteoporosis.', 'detailedDescription': 'Falling is a major health problem in the elderly causing physical and psychosocial problems. People with osteoporosis are at higher risk for fractures due to falling, because of decreased bone strength. The \'Nijmegen Falls Prevention Program" (NFPP) (Weerdesteyn et al, 2006) has been shown to reduce fall incidence rates by 46% in healthy community-dwelling elderly. This program was adapted in order to meet the specific demands and constraints of people with osteoporosis.\n\nThe contents of the program are an obstacle course, walking exercises, the practice of fall techniques, adjustment of gait abnormalities, weight bearing exercises and educational sessions.\n\nThe effectiveness of the program will be evaluated in a randomized clinical trial. Primary outcome measure is fall incidence. Additionally, laboratory assessments of gait and obstacle avoidance will be conducted in conjunction with questionnaires about balance confidence and activity level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* osteoporosis (DXA T-score \\< -2.5 in hip and/or vertebrae)\n* able to walk at least 15 minutes without an helping device\n* 65 years or older\n* community dwelling\n* at least one fall in the prior year\n\nExclusion Criteria:\n\n* severe cardiac, pulmonary or musculoskeletal disorders\n* pathologies associated with increased fall risks (i.e. stroke or Parkinson's disease)\n* use of psychotropic drugs"}, 'identificationModule': {'nctId': 'NCT00432692', 'briefTitle': 'Falls Prevention in Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'Sint Maartenskliniek'}, 'officialTitle': 'Falls Prevention for People With Increased Risk of Fractures as a Result of Osteoporosis: a Randomized Controlled Study on the Effects of a Modified Program', 'orgStudyIdInfo': {'id': 'SMK001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Falls Prevention Program', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Sint Maartenskliniek', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Ellen Smulders, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sint Maartenskliniek'}, {'name': 'Vivian Weerdesteyn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sint Maartenskliniek'}, {'name': 'Wim van Lankveld, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sint Maartenskliniek'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sint Maartenskliniek', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}]}}}