Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-31 @ 2:38 AM
Study NCT ID:
NCT04988334
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2021-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Capacity to Reduce Fall-Related Injury Risk in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'wait list control to intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'physical activity', 'timeFrame': '12 weeks', 'description': 'physical activity scale for the elderly'}, {'measure': 'fall history', 'timeFrame': '12 weeks', 'description': 'questionnaire'}], 'primaryOutcomes': [{'measure': 'Muscle strength dynamic', 'timeFrame': '12 weeks', 'description': 'concentric and eccentric isokinetic dynamometry'}, {'measure': 'Muscle Strength isometric', 'timeFrame': '12 weeks', 'description': 'Hand held dynamometry'}, {'measure': 'Muscle Strength isometric', 'timeFrame': '12 weeks', 'description': 'grip strength'}, {'measure': 'Muscle strength isometric', 'timeFrame': '12 weeks', 'description': 'push off test'}, {'measure': 'response time', 'timeFrame': '12 weeks', 'description': 'signal to touch on force plate'}, {'measure': 'Balance', 'timeFrame': '12 weeks', 'description': 'one leg stand'}, {'measure': 'Balance', 'timeFrame': '12 weeks', 'description': 'tandem stand'}, {'measure': 'Balance', 'timeFrame': '12 weeks', 'description': 'modified clinical test of sensory interaction and balancer'}, {'measure': 'Balance Confidence', 'timeFrame': '12 weeks', 'description': 'Activities balance confidence scale'}, {'measure': 'Fall Risk', 'timeFrame': '12 weeks', 'description': 'Fall Risk for older people in the community-screen'}, {'measure': 'timed up and go test', 'timeFrame': '12 weeks', 'description': 'stand, walk 3 meters, turn and return to sit'}, {'measure': 'chair stand', 'timeFrame': '12 weeks', 'description': '30-second chair stand test'}, {'measure': 'gait velocity', 'timeFrame': '12 weeks', 'description': 'timed 6 meters within 10 meter walk'}, {'measure': 'fall landing capacity', 'timeFrame': '12 weeks', 'description': 'energy absorption, force, elbow range of motion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fall Injury']}, 'descriptionModule': {'briefSummary': "Fall Arrest Strategy Training (FAST) is a unique, simple exercise program designed to improve one's ability to prevent injury when a fall is unavoidable. Women are more likely to participate in fall prevention programming than men despite risk of serious fall related injuries such as head injury similar in both men and women. The purpose of this project is to test differences between men and women's physical capacity to control the downward descent of a forward fall and prevent injury and to understand factors that influence participation of women and men in fall prevention programming. A total of 60 seniors (30 men and 30 women) age 60 years or older will do their regular activities for 12 weeks followed by 12 weeks of FAST training. They will be tested before and after for muscle strength, balance and their ability to land and descend in a simulated forward fall using a safe protocol in our lab. Group discussions among women and men after FAST will help us determine facilitators and barriers to exercise participation.", 'detailedDescription': 'The purpose of this proposed study is to advance our knowledge of this innovative and simple training program, FAST, to determine if it has potential to improve the physical capacity to arrest a fall and reduce injury risk in older community-dwelling women and men. Using our novel lab-based energy absorption and strength measures, we will be able to compare fall-arrest capacity changes in older men and women.This study will also help to inform strategies to engage older men in exercise programming.\n\nResearch Goals and Objectives: The principal research questions of this study are:\n\n1. Does the FAST improve fall arrest capacity in older women and men as compared to usual activity (wait control period)?,\n2. Does FAST increase arm muscle strength, response time, mobility and balance control compared to usual activity? ,\n3. Are there sex differences in fall risk changes, fall arrest capacity, and chance of head impact? and\n4. Do men differ from women in their perceptions of the barriers and facilitators to participating in FAST? The hypotheses are that: 1) FAST will result in greater improvements in energy absorption, UE strength, response time and mobility compared to usual activity for both older men and women; however 2) men will demonstrate enhanced fall arrest capacity and 3) will identify unique barriers and facilitators to participation compared to women.\n\nThe study is a quasi-experimental pre-post design with a wait list control period where 60 men and women, age 60 years or older will be recruited to participate in FAST.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 60 years living in the community\n\nExclusion Criteria:\n\n* recent upper body injury or pain,\n* recent or history of more than one distal radial fracture,\n* history of upper extremity neurological conditions or conditions contradicting upper extremity strength testing or training,\n* signs of severe cognitive impairment identified with the mini-Cog\n* unable to safely ambulate independently in the community'}, 'identificationModule': {'nctId': 'NCT04988334', 'acronym': 'FAST2', 'briefTitle': 'Improving Capacity to Reduce Fall-Related Injury Risk in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Improving Capacity to Reduce Fall-Related Injury Risk in Older Adults', 'orgStudyIdInfo': {'id': 'University of Saskatchewan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FAST', 'description': '12 weeks of FAST, 2/week 45 minute sessions with half hour per week of education, same group of men and women', 'interventionNames': ['Other: Wait Control']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'wait control', 'description': '12 weeks of usual activity prior to intervention, same group of men and women', 'interventionNames': ['Other: Wait Control']}], 'interventions': [{'name': 'Wait Control', 'type': 'OTHER', 'description': 'usual activities', 'armGroupLabels': ['FAST', 'wait control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N 2Z4', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Cathy o Arnold', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Physical Therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'de-identified group data to be shared via peer review publication and on request to corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Saskatchewan Health Research Foundation', 'class': 'OTHER'}, {'name': 'Saskatchewan Centre for Patient-Oriented Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Cathy Arnold', 'investigatorAffiliation': 'University of Saskatchewan'}}}}