Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT01733303
Status:
UNKNOWN
Last Update Posted:
2012-11-27
First Post:
2012-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fracture and Fall Prevention in Elderly 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': {'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-11-20', 'studyFirstSubmitDate': '2012-10-05', 'studyFirstSubmitQcDate': '2012-11-20', 'lastUpdatePostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of torque demand to capacity ratio 6 months', 'timeFrame': 'Change from Baseline intorque demand to capacity ratio at 6 months'}, {'measure': 'Changes of torque demand to capacity ratio at 3 months', 'timeFrame': 'Change from Baseline in torque demand to capacity ratio at 3 months'}, {'measure': 'Change of torque demand to capacity ratio at 12months', 'timeFrame': 'Change from Baseline in torque demand to capacity ratio at 12 months'}]}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'Osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury or mortality. Identifying the factors related to falls occurring within this population is essential for the development of effective regimes for fall prevention. Studies have shown that muscle quality and good posture alignments are critical for balance control in older adults. People are diagnosed with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading vertebral, fractures and poor balance control, even falls. Therefore, improving muscle quality, strengthening weak muscles and correcting postural alignment are essential elements for fracture and fall prevention in older adults with osteoporosis. The long-term objectives of this work are to prevent fracture and fall in older adults with osteoporosis by improving the function of degenerative muscles using exercise training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The inclusion criteria for osteopenia or osteoporosis group:\n\n1. able to stand and walk for 5 minutes independently;\n2. having normal or corrected to normal vision;\n3. having age between \\> 50 years\n4. with osteopenia (-2.5 \\< t-score \\< -1.0) or osteoporosis (t-score \\<-2.5).\n\nThe exclusion criteria for osteopenia or osteoporosis group:\n\n1. being pregnant;\n2. sensory-motor deficits;\n3. inability of communication\n4. lack of access to a telephone.\n\nThe inclusion criteria for control age-matched group:\n\n1. able to stand and walk for 5 minutes independently;\n2. having normal or corrected to normal vision;\n3. having age between \\> 50 years\n4. without osteopenia or osteoporosis (t-score \\> -1.0).\n\nThe exclusion criteria for control age-matched group:\n\n1. being pregnant;\n2. sensory-motor deficits;\n3. inability of communication\n4. lack of access to a telephone.'}, 'identificationModule': {'nctId': 'NCT01733303', 'briefTitle': 'Fracture and Fall Prevention in Elderly With Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Fracture and Fall Prevention in Elderly With Osteoporosis', 'orgStudyIdInfo': {'id': '201003065R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'Participants are allocated to the exercise group will commence the personalized core training exercise with EMG biofeedback based on their testing results in muscle quality.', 'interventionNames': ['Behavioral: personalized core muscle training program']}], 'interventions': [{'name': 'personalized core muscle training program', 'type': 'BEHAVIORAL', 'description': 'Participants are allocated to the exercise group will commence the personalized core training exercise with EMG biofeedback based on their testing results in muscle quality. The program will run for 3 months with patients attending for one hour three times a week. The age-matched control group will maintain their usual daily life activities without any specific instruction. The exercise training will be run by an experienced physiotherapist, who will encourage patients individually to progress at their own pace.', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10055', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Weili Hsu, PhD', 'role': 'CONTACT', 'email': 'wlhsu@ntu.edu.tw', 'phone': '886-2-3366-8127'}], 'facility': 'Physical Therapy Center or the Orthopedic Center in the National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Weili Hsu, PhD', 'role': 'CONTACT', 'email': 'wlhsu@ntu.edu.tw', 'phone': '886-2-3366-8127'}], 'overallOfficials': [{'name': 'Weili Hsu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}