Recruiting

Vivo Knee OA

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT06462560

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Vivo Online Exercise Program

Medbridge Home program

Study Details

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 ID

NCT06462560

Start date

Apr 28, 2024

Status verified date

Jun, 2024

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

334 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vivo Online Exercise program

active comparator: Medbridge Home Exercise Program

Interventions

Vivo Online Exercise Program

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

Medbridge Home program

At home exercise program accessed through exercise descriptions and short vidoes

Primary outcome measure

  • Primary Endpoint 1 [ Time Frame: 6 months post intervention ]

Central Contacts and Locations

Central contacts

Amelia Millward

801-507-8095amelia.millward@imail.org

Locations

Intermountain Health

Recruiting

Murray, Utah, United States, 84107

Contacts

Amelia Millward

801-507-8095amelia.millward@imail.org

Principal Investigator:

Anthony Beutler, MD

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Jun 17, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2024-06-17.