Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT01830634
Status:
COMPLETED
Last Update Posted:
2020-01-31
First Post:
2013-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower-limb Strength and Flexibility Program on Prevention of Falls in the Community-dwelling Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-29', 'studyFirstSubmitDate': '2013-04-10', 'studyFirstSubmitQcDate': '2013-04-11', 'lastUpdatePostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Computerized balance evaluation', 'timeFrame': 'after 3 months intervention', 'description': 'computerized balance and gait evaluation by a posturography and gait analysis system'}], 'secondaryOutcomes': [{'measure': 'improve in functional activity', 'timeFrame': 'after 3 months intervention', 'description': 'functional reach and timed up-and-go test'}]}, 'conditionsModule': {'keywords': ['Community-dwelling elderly', 'Rehabilitation', 'Theraband', 'Strengthening and stretching exercise'], 'conditions': ['Accidental Falls']}, 'descriptionModule': {'briefSummary': 'Accidental falls result in major physical and psychological morbidity in the elderly. The aim of this study was to evaluate the effects of lower-limb strength and flexibility program, which is analyzed under the control of other risk factors, on preventing falls and fall-related injuries in the community-dwelling elderly.', 'detailedDescription': 'To estimate the effect of strength and flexibility training with elastic band on community-dwelling elderly gait, balance, and functional performance. All subjects received a home exercise program with low resistance elastic band training. All subjects were assessed for functional assessment, balance and gait analysis at initial and after training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elder living in community\n* age \\> 65 years old\n\nExclusion Criteria:\n\n* no walking ability before fall\n* conscious change or disease induce fall\n* impaired cognition'}, 'identificationModule': {'nctId': 'NCT01830634', 'briefTitle': 'Lower-limb Strength and Flexibility Program on Prevention of Falls in the Community-dwelling Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Changhua Christian Hospital'}, 'officialTitle': 'Effect of Strength and Flexibility Training With Elastic Band on Gait Pattern and Functional Ability in the Elderly', 'orgStudyIdInfo': {'id': 'I050507'}, 'secondaryIdInfos': [{'id': 'NSC-93-2314-B-371-002', 'type': 'OTHER', 'domain': 'National Science Council'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Theraband with strengthening and stretching exercise', 'description': 'All subjects were received theraband exercises (strengthening and stretching), and then compare the measured outcomes between groups.', 'interventionNames': ['Behavioral: Theraband with strengthening and stretching exercise']}], 'interventions': [{'name': 'Theraband with strengthening and stretching exercise', 'type': 'BEHAVIORAL', 'description': 'Using the theraband for strengthening and stretching the upper and lower extremity muscles.\n\nAll exercises were performed by using a Theraband in the following movements: shoulder elevating and abducting, horizontal and oblique direction, plantar flexion, dorsi-flexion, inversion and eversion of ankle, knee extension and hip abduction. The stretching exercises were focused on the hamstring muscle and heel cord. Each movement was held for 5 seconds. The participants were instructed to perform 5-10 repetitions of each movements twice per day.', 'armGroupLabels': ['Theraband with strengthening and stretching exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500', 'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Changhua Christian Hospital Taiwan', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}], 'overallOfficials': [{'name': 'TaSen Wei', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhua Christian Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhua Christian Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Ta-Sen Wei,MD', 'investigatorAffiliation': 'Changhua Christian Hospital'}}}}