Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT06931067
Status:
RECRUITING
Last Update Posted:
2025-04-16
First Post:
2025-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OTAGO Exercise Program and Motivational Interviewing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-09', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OTAGO exercise adherence', 'timeFrame': 'Baseline, 6-months & 12 months', 'description': 'Number of instructed OTAGO exercises completed in a week'}], 'secondaryOutcomes': [{'measure': '4-stage balance test', 'timeFrame': 'Baseline & 6-months', 'description': 'Participants are asked to hold four standing positions that get progressively harder to maintain.\n\n1. Stand with your feet side-by-side\n2. Place the instep of one foot so it is touching the big toe of the other foot.\n3. Tandem stance Place one foot in front of the other, heel touching toes\n4. Stand on one foot.'}, {'measure': 'Sit-to-stand test', 'timeFrame': 'Baseline & 6-months', 'description': 'Participants are asked to stand from a seated position. We count the number of sit-stand-sit repetitions completed during 30 seconds'}, {'measure': 'Falls Efficacy Scale Short International', 'timeFrame': 'Baseline, 6-months, and 12-months', 'description': 'Measures levels of concern about falls. 7-item, 4-point Likert-type scale; 28: highest concern'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OTAGO', 'OEP', 'Motivational interviewing', 'behavior change'], 'conditions': ['Fall Risk Factors', 'Physical Activity', 'Engagement, Patient', 'Community-dwelling Older Adults']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to see if OTAGO instructors, who have been trained in a special communication method called motivational interviewing, can help older adults start and stick with the OTAGO exercise program. The results will help guide future research on how behavior change techniques can support other fall prevention strategies.', 'detailedDescription': "The objective of this study is to evaluate the feasibility and impact of OTAGO instructors who are trained in motivational interviewing communication approach to facilitate older adult's uptake of the OTAGO exercises. This study will create the basis for future trials that will explore the impact of behavior change interventions on other fall prevention strategies.\n\nWe propose a single-arm quasi-experimental trial with older adults with high fall risks. The study intervention consists of OTAGO visits by study staff (MI-trained OTAGO instructor) over 6 months to improve older adults' engagement in fall prevention behaviors with a focus on OTAGO exercises. Participants will be followed for additional 6 months for the total study duration of 12 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥60\n* At high fall risk: At least one "Yes" to 1) had a fall in the past year; 2) answer "difficult" to the question "do you find it hard to stand without using your hands"; 3) worry about falling\n* Able to converse audibly and coherently in English\n* Ambulatory with or without assistive device use\n* Self-report challenges navigating the environment outside of the home\n* At least one "some or much difficulty" or "unable to do" to:Walking one block?; Stepping up onto a curb?; Getting out of a straight back chair? Climbing one flight of stairs? Getting out of the house\n\nExclusion Criteria:\n\n* o Receiving ongoing physical therapy with a primary focus on improving balance and strength of lower extremities\n\n * Experiencing acute health issues such as fracture, pain, or infection that prohibits them from participating in exercises\n * Able to stand on one foot for more than 10 seconds without holding onto something\n * 6-item Callahan cognitive assessment over the phone: Patients with scores of 2 or less, positive for dementia criteria, will be excluded.\n * Patients participating in other studies that may impact fall-related behavior change.\n * Participants engaged in routine moderate or vigorous physical activities that require lower extremity balance and strength (e.g., \\>100 minutes/week for more than 3 months)'}, 'identificationModule': {'nctId': 'NCT06931067', 'briefTitle': 'OTAGO Exercise Program and Motivational Interviewing', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Health Behavior Change for Fall Prevention', 'orgStudyIdInfo': {'id': '27787'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'OTAGO exercise home visits will be offered 7 times with 2 phone-based check-ins during the 6-month period. As part of OTAGO home visits, participants will receive OTAGO exercise instruction and MI. Each home visit will be approximately an hour.', 'interventionNames': ['Behavioral: OTAGO Exercise Program with motivational interviewing']}], 'interventions': [{'name': 'OTAGO Exercise Program with motivational interviewing', 'type': 'BEHAVIORAL', 'description': 'OTAGO exercise home visits will be offered 7 times with 2 phone-based check-ins during the 6-month period. As part of OTAGO home visits, participants will receive OTAGO exercise instruction and MI. Each home visit will be approximately an hour.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Hiroko Kiyoshi-Teo, PhD, RN', 'role': 'CONTACT', 'email': 'kiyoshi@ohsu.edu', 'phone': '5034943858'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After the completion of all study data collection, analysis, and publication. IPD will be available for 5 years.', 'ipdSharing': 'YES', 'description': 'De-identified study IPD may be shared upon request.', 'accessCriteria': 'Individuals interested in IPD must contact the PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon Wellness Network', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hiroko Kiyoshi-Teo', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}