Live and Interactive Fitness Training Program (Vivo Knee OA)

NCT ID: NCT06462560

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-28
• Study Completion Date: 2026-04-30

Brief Summary

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vivo Online Exercise program

Group Type: EXPERIMENTAL

Vivo Online Exercise Program

Intervention Type: OTHER

Virtual online exercise programs conducted by the Vivo team consisting of multiple time a week group live programs

Medbridge Home Exercise Program

Group Type: ACTIVE_COMPARATOR

Medbridge Home program

Intervention Type: OTHER

At home exercise program accessed through exercise descriptions and short vidoes

Interventions

Vivo Online Exercise Program

Virtual online exercise programs conducted by the Vivo team consisting of multiple time a week group live programs

Intervention Type: OTHER

Medbridge Home program

At home exercise program accessed through exercise descriptions and short vidoes

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 55-85 years of age
• Diagnosis of Osteoarthritis within the prior 6 months
• Symptomatic OA defined as self-report:

• Pain in the knee(s) on most days of the month
• Difficulty with at least one of the following because of knee pain:

• walking ¼ of a mile
• climbing stairs
• getting in and out of a car, bath, or bed
• rising from a chair
• or performing shopping, cleaning, or self-care activities
• Radiographic KL grade II-III (using Kellgren and Lawrence criteria) of one or both knees
• Physically able to participate in strength training - able to do one chair stand unassisted in order to test change in 30-second chair stand
• Ambulatory and community-dwelling
• Sedentary or insufficiently active as measured by the PAVS
• Access to Wi-Fi in defined exercise space
• BMI of 20-34.9 kg/m2
• Document medication specific to OA and knee pain
• Willing and able to provide consent

Exclusion Criteria

• Neurological conditions causing functional impairments (Parkinson's disease, MS, ALS)
• Diagnosis of dementia
• Inability to complete ≥1 ADLs without assistance.
• Knee surgery in the past 6 months
• Severe osteoporosis T-score < -3.5
• No concurrent enrollment in physical therapy for knee pain
• No concurrent enrollment in the Intermountain Arthrofit program
• Under the age of 55 or ≥85
• Asymptomatic OA
• Not having knee pain or having significant knee pain (WOMAC Pain score of ≤3 or ≥18)
• KL Grade 1 or 4
• BMI above 34.9 kg/m2 or ≤20 kg/m2
• Participation in formal strength training more than 30 minutes a week in the past 6 months.
• 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.
• Co-morbid disease that would threaten safety or impair ability to participate in a live and interactive strength training program
• Symptomatic or severe coronary artery disease; peripheral vascular disease
• Untreated hypertension
• Active cancer other than skin cancer

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Impactiv, Inc.

INDUSTRY

Sponsor Role: collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Beutler, MD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Health

Locations

Intermountain Health

Murray, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amelia Millward

Role: CONTACT

amelia.millward@imail.org

801-507-8095

Facility Contacts

Amelia Millward

Role: primary

amelia.millward@imail.org

801-507-8095

Other Identifiers

1052693

Identifier Type: -

Identifier Source: org_study_id