Live and Interactive Fitness Training Program (Vivo Knee OA) (LIFT-OA)

Improving Physical Function and Quality of Life in Adults With Knee Osteoarthritis Utilizing an Online Live and Interactive Fitness Training Program (Vivo Knee OA)

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Vivo Online Exercise Program; Other: Medbridge Home program

• Study Type: Interventional
• Enrollment (Estimated): 334
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amelia Millward; Phone Number: 801-507-8095; Email: amelia.millward@imail.org

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Intermountain Health
      • Contact: Amelia Millward; Phone Number: 801-507-8095; Email: amelia.millward@imail.org
      • Principal Investigator: Anthony Beutler, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vivo Online Exercise program	Other: Vivo Online Exercise Program; Virtual online exercise programs conducted by the Vivo team consisting of multiple time a week group live programs
Active Comparator: Medbridge Home Exercise Program	Other: Medbridge Home program; At home exercise program accessed through exercise descriptions and short vidoes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint 1	Changes from baseline in number of chair stands done in 30-seconds at 3 and 6 months.	6 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint 1	Changes from baseline in WOMAC score at 3 and 6 months.	6 months post intervention
Secondary Endpoint 2	Changes from baseline in length of time (seconds) to do 1-leg balance stance at 3 and 6 months.	6 months post intervention
Secondary Endpoint 3	Changes from baseline in seconds to complete the 8-foot up and go at 3 and 6 months.	6 months post intervention
Secondary Endpoint 4	Changes from baseline in number of knee raises completed in 2-minute knee raise at 3 and 6 months	6 months post intervention
Secondary Endpoint 5	Changes from baseline in number of arm-curls done in 30 seconds at 3 and 6 months	6 months post intervention
Secondary Endpoint 6	Changes from baseline in PROMIS-Plus-Osteoarthritis of the Knee (OAK) score at 3 and 6 months	6 months post intervention
Secondary Endpoint 7	Changes from baseline in exercise self-efficacy scale score at 3 and 6 months	6 months post intervention
Secondary Endpoint 8	Changes from baseline in quality of life (SF-36 score) at 3 and 6 months	6 months post intervention

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: Impactiv, Inc.
• Investigators: Principal Investigator: Anthony Beutler, MD, Intermountain Health

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 1052693

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No