Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:47 PM
Study NCT ID:
NCT01210469
Status:
COMPLETED
Last Update Posted:
2010-10-06
First Post:
2010-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-05', 'studyFirstSubmitDate': '2010-09-27', 'studyFirstSubmitQcDate': '2010-09-27', 'lastUpdatePostDateStruct': {'date': '2010-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postural Control', 'timeFrame': 'eight weeks', 'description': 'Postural control was evaluated by Modified Clinical Test of Sensory Interaction for Balance (CTSIBm) and Limits of Stability test (LOS) in Balance Master force plate'}], 'secondaryOutcomes': [{'measure': 'Postural alignment', 'timeFrame': 'eight weeks', 'description': 'Postual alignment (thoracic kyphosis and forward head) measured by PAS/SAPO (Postural Assessment Software)'}, {'measure': 'Lower limb muscle strength', 'timeFrame': 'eight weeks', 'description': 'The muscle strength in knee extension and knee flexion was evaluated by dynamometry.'}, {'measure': 'Shortening of the hamstrings', 'timeFrame': 'eight weeks', 'description': 'The shortening of the hamstrings was evaluated by goniometry.'}, {'measure': 'Berg Balance Scale', 'timeFrame': 'Eight weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['elderly', 'postural balance', 'musculoskeletal equilibrium', 'posture', 'muscle strength', 'muscle stretching exercises'], 'conditions': ['Osteoporosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.teses.usp.br/teses/disponiveis/5/5163/tde-08032010-162215/', 'label': 'Link to my thesis in portuguese'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was compare the efficacy of two exercise programs - the first consisting of balance training and muscle strength and the second consisting of balance training and muscle stretching exercises - to improve postural control in elderly women with osteoporosis.', 'detailedDescription': 'The decrease in postural control and muscle strength in lower limbs have been identified as major risk factors for falls in older people. Exercises have proven effective in decreasing risk factors in healthy elderly, but little is known about the effects of interventions with exercise in the elderly with osteoporosis.\n\nObjective: To compare the efficacy of two exercise programs - the first consisting of balance training and muscle strength and the second consisting of balance training and muscle stretching exercises - to improve postural control in elderly women with osteoporosis.\n\nMethods: Fifty elderly aged 65 or older, with a diagnosis of osteoporosis, were randomized into 3 groups: Strength Group (n = 17) performed balance training with muscle strengthening; Stretching Group (n = 17) performed balance training with stretching; and Control Group (n =16) did not do activity. The groups trained for 8 weeks, with sessions of about 60 minutes, twice a week. Postural control was evaluated by Modified Clinical Test of Sensory Interaction for Balance (CTSIBm) and Limits of Stability test (LOS) in Balance Master force plate, the functional balance by Berg Balance Scale (BBS), muscle strength by dynamometry, the shortening of the hamstrings by goniometry and posture by PAS/SAPO (Postural Assessment Software).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women from 65 to 80 yrs of age\n* diagnosis of osteoporosis classified according to the criteria of the World Health Organization, with bone mineral densitometry reduced by at least 2.5 SD when compared with young adults (region of lumbar spine)\n\nExclusion Criteria:\n\n* severe visual deficiency\n* physically incapable of participating in the tests\n* neurological disorders, amputations, or prostheses\n* individuals with regular physical activity (twice or more per week) or who had recently participated in exercise programs for muscular strength or balance'}, 'identificationModule': {'nctId': 'NCT01210469', 'briefTitle': 'Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '787/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Strengthening Group', 'description': 'Performed balance training with lower limbs muscle strengthening.', 'interventionNames': ['Other: Strengthening and balance exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Stretching Group', 'description': 'Performed balance training with stretching', 'interventionNames': ['Other: Stretching and balance exercises']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Strengthening and balance exercises', 'type': 'OTHER', 'otherNames': ['Force Platform', 'Balance Master'], 'description': 'The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.', 'armGroupLabels': ['Strengthening Group']}, {'name': 'Stretching and balance exercises', 'type': 'OTHER', 'otherNames': ['Force Platform', 'Balance Master'], 'description': 'The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.', 'armGroupLabels': ['Stretching Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of Sao Paulo General Hospital', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Thomaz N Burke, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Thomaz Nogueira Burke, Ms', 'oldOrganization': 'University of São Paulo'}}}}