Live and Interactive Fitness Training Program (Vivo Knee OA)

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Other: Vivo Online Exercise Program; Other: Medbridge Home program

• Registration Number: NCT06462560
• Lead Sponsor: Intermountain Health Care, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-28
• Status Verified: 2024-06
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-17
• Last Update Posted: 2024-06-17
• Primary Completion: 2025-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 334

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vivo Online Exercise program	Vivo Online Exercise Program	-
Medbridge Home Exercise Program	Medbridge Home program	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Intermountain Health; 🇺🇸 Murray, Utah, United States