Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-17 @ 7:52 PM
Study NCT ID:
NCT02762305
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2016-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of the RSVP Bone Builders Program on Strength, Balance, Fall Risk and Life Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-21', 'studyFirstSubmitDate': '2016-05-03', 'studyFirstSubmitQcDate': '2016-05-03', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '10 Meter Walking Test', 'timeFrame': '12 weeks', 'description': 'Measures gait speed'}, {'measure': 'Timed Up and Go Test', 'timeFrame': '12 weeks', 'description': 'Measures gait speed \\& fall risk'}, {'measure': 'Five Time Sit to Stand Test', 'timeFrame': '12 weeks', 'description': 'Measures leg strength \\& fall risk'}, {'measure': 'Computerized Dynamic Posturography with NeuroCom Smart Equitest', 'timeFrame': '12 weeks', 'description': 'Measures balance abilities \\& fall risk'}, {'measure': 'Berg Balance Scale', 'timeFrame': '12 weeks', 'description': 'Measures balance abilities \\& fall risk'}, {'measure': 'Activities-specific Balance Confidence (ABC) Scale', 'timeFrame': '12 weeks', 'description': 'Measures balance confidence \\& fall risk'}, {'measure': 'Satisfaction with Life Scale', 'timeFrame': '12 weeks', 'description': 'Measures life satisfaction'}]}, 'conditionsModule': {'keywords': ['fall risk', 'RSVP bone builders', 'group exercise', 'older adults', 'balance confidence', 'life satisfaction', 'balance', 'walking speed'], 'conditions': ['Exercise']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that participation in the Retired and Senior Volunteer Program (RSVP) Bone Builders program 1 hour, twice per week, for 12 weeks may result in significant positive changes to the health status of older adult participants as demonstrated by increased leg strength and walking speed, improved balance and balance confidence, and enhanced life satisfaction. These improvements may lead to a reduction in risk of falls.', 'detailedDescription': 'The purpose of this study was to examine the efficacy of the RSVP Bone Builders program, to document benefits this program may have for older adults and also provide additional evidence that further confirms the importance of exercise for the older adult population. Exercise has the potential to reduce falls, injuries, emergency room visits, surgeries, insurance costs, and improve the overall quality of life in the older adult population. If the RSVP Bone Builders proves to be beneficial for older adults, the program could be recommended by healthcare and exercise professionals for their patients and clients who are at risk for falls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* able to walk independently with or without a cane or walker,\n* not currently participating in the RSVP Bone Builders program,\n* scoring at least 24/30 on the Mini-Mental State Examination (MMSE) and clearance of Physical Activity Readiness Questionnaire (Par-Q)\n\nExclusion Criteria:\n\n* if they use a wheelchair in the community for mobility,\n* have any known neurological, musculoskeletal, cardiopulmonary, or other medical condition that will not allow full participation in the RSVP Bone Builders program, and\n* if the subjects score less than 24/30 on the MMSE'}, 'identificationModule': {'nctId': 'NCT02762305', 'briefTitle': 'The Effects of the RSVP Bone Builders Program on Strength, Balance, Fall Risk and Life Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'California State University, Northridge'}, 'officialTitle': 'The Effects of the RSVP Bone Builders Program on Intrinsic Fall Risk Factors & Life Satisfaction', 'orgStudyIdInfo': {'id': '1516-091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RSVP Bone Builder group exercise', 'description': 'A group of older adults who are participating in the RSVP Bone Builder group exercise.', 'interventionNames': ['Other: RSVP Bone Builders Group Exercise']}], 'interventions': [{'name': 'RSVP Bone Builders Group Exercise', 'type': 'OTHER', 'armGroupLabels': ['RSVP Bone Builder group exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Equilibrium Balance Performance Center', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}], 'overallOfficials': [{'name': 'Jillian Giannini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'California State University, Northridge'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California State University, Northridge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}