Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 12:33 PM
Study NCT ID:
NCT06462560
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Live and Interactive Fitness Training Program (Vivo Knee OA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 334}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-06-12', 'lastUpdatePostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoint 1', 'timeFrame': '6 months post intervention', 'description': 'Changes from baseline in number of chair stands done in 30-seconds at 3 and 6 months.'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoint 1', 'timeFrame': '6 months post intervention', 'description': 'Changes from baseline in WOMAC score at 3 and 6 months.'}, {'measure': 'Secondary Endpoint 2', 'timeFrame': '6 months post intervention', 'description': 'Changes from baseline in length of time (seconds) to do 1-leg balance stance at 3 and 6 months.'}, {'measure': 'Secondary Endpoint 3', 'timeFrame': '6 months post intervention', 'description': 'Changes from baseline in seconds to complete the 8-foot up and go at 3 and 6 months.'}, {'measure': 'Secondary Endpoint 4', 'timeFrame': '6 months post intervention', 'description': 'Changes from baseline in number of knee raises completed in 2-minute knee raise at 3 and 6 months'}, {'measure': 'Secondary Endpoint 5', 'timeFrame': '6 months post intervention', 'description': 'Changes from baseline in number of arm-curls done in 30 seconds at 3 and 6 months'}, {'measure': 'Secondary Endpoint 6', 'timeFrame': '6 months post intervention', 'description': 'Changes from baseline in PROMIS-Plus-Osteoarthritis of the Knee (OAK) score at 3 and 6 months'}, {'measure': 'Secondary Endpoint 7', 'timeFrame': '6 months post intervention', 'description': 'Changes from baseline in exercise self-efficacy scale score at 3 and 6 months'}, {'measure': 'Secondary Endpoint 8', 'timeFrame': '6 months post intervention', 'description': 'Changes from baseline in quality of life (SF-36 score) at 3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Potential participants will be screened at clinic. Patients who meet eligibility criteria will be considered for study. After written informed consent is obtained, participants will complete baseline testing and participants who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Vivo Arm: Vivo twice a week for 6 months and Usual Care Arm: meet with ATC and given Medbridge home exercise program for 6 months. All participants will be followed for 12 months, and will be assessed at 3-,6-, and 12-months. All participants will complete functional assessments, OA patient reported outcomes measures, quality of life, exercise self-efficacy, and fall risk questionnaires, and health care utilization report at each testing visit. A subset of Vivo participants will be asked satisfaction questions at the 3 and 6 month time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 55-85 years of age\n* Diagnosis of Osteoarthritis within the prior 6 months\n* Symptomatic OA defined as self-report:\n\n * Pain in the knee(s) on most days of the month\n * Difficulty with at least one of the following because of knee pain:\n\n * walking ¼ of a mile\n * climbing stairs\n * getting in and out of a car, bath, or bed\n * rising from a chair\n * or performing shopping, cleaning, or self-care activities\n* Radiographic KL grade II-III (using Kellgren and Lawrence criteria) of one or both knees\n* Physically able to participate in strength training - able to do one chair stand unassisted in order to test change in 30-second chair stand\n* Ambulatory and community-dwelling\n* Sedentary or insufficiently active as measured by the PAVS\n* Access to Wi-Fi in defined exercise space\n* BMI of 20-34.9 kg/m2\n* Document medication specific to OA and knee pain\n* Willing and able to provide consent\n\nExclusion Criteria:\n\n* Neurological conditions causing functional impairments (Parkinson's disease, MS, ALS)\n* Diagnosis of dementia\n* Inability to complete ≥1 ADLs without assistance.\n* Knee surgery in the past 6 months\n* Severe osteoporosis T-score \\< -3.5\n* No concurrent enrollment in physical therapy for knee pain\n* No concurrent enrollment in the Intermountain Arthrofit program\n* Under the age of 55 or ≥85\n* Asymptomatic OA\n* Not having knee pain or having significant knee pain (WOMAC Pain score of ≤3 or ≥18)\n* KL Grade 1 or 4\n* BMI above 34.9 kg/m2 or ≤20 kg/m2\n* Participation in formal strength training more than 30 minutes a week in the past 6 months.\n* PAVS - Participating in 150 minutes per week of moderate intensity physical activity or 75 minutes of vigorous intensity activity, or an equivalent combination of moderate and vigorous intensity physical activity.\n* Co-morbid disease that would threaten safety or impair ability to participate in a live and interactive strength training program\n* Symptomatic or severe coronary artery disease; peripheral vascular disease\n* Untreated hypertension\n* Active cancer other than skin cancer"}, 'identificationModule': {'nctId': 'NCT06462560', 'acronym': 'LIFT-OA', 'briefTitle': 'Live and Interactive Fitness Training Program (Vivo Knee OA)', 'organization': {'class': 'OTHER', 'fullName': 'Intermountain Health Care, Inc.'}, 'officialTitle': 'Improving Physical Function and Quality of Life in Adults With Knee Osteoarthritis Utilizing an Online Live and Interactive Fitness Training Program (Vivo Knee OA)', 'orgStudyIdInfo': {'id': '1052693'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vivo Online Exercise program', 'interventionNames': ['Other: Vivo Online Exercise Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medbridge Home Exercise Program', 'interventionNames': ['Other: Medbridge Home program']}], 'interventions': [{'name': 'Vivo Online Exercise Program', 'type': 'OTHER', 'description': 'Virtual online exercise programs conducted by the Vivo team consisting of multiple time a week group live programs', 'armGroupLabels': ['Vivo Online Exercise program']}, {'name': 'Medbridge Home program', 'type': 'OTHER', 'description': 'At home exercise program accessed through exercise descriptions and short vidoes', 'armGroupLabels': ['Medbridge Home Exercise Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amelia Millward', 'role': 'CONTACT', 'email': 'amelia.millward@imail.org', 'phone': '801-507-8095'}, {'name': 'Anthony Beutler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Intermountain Health', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}], 'centralContacts': [{'name': 'Amelia Millward', 'role': 'CONTACT', 'email': 'amelia.millward@imail.org', 'phone': '801-507-8095'}], 'overallOfficials': [{'name': 'Anthony Beutler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intermountain Health Care, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Impactiv, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}