Clinical trial NCT06462560: Live and Interactive Fitness Training Program (Vivo Knee OA)
Official title: Improving Physical Function and Quality of Life in Adults With Knee Osteoarthritis Utilizing an Online Live and Interactive Fitness Training Program (Vivo Knee OA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Impactiv, Inc.
First posted: 2024-06-17
Enrollment: 334
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Primary Endpoint 1
timeFrame: 6 months post intervention
Secondary outcomes:
measure: Secondary Endpoint 1
timeFrame: 6 months post intervention
measure: Secondary Endpoint 2
timeFrame: 6 months post intervention
measure: Secondary Endpoint 3
timeFrame: 6 months post intervention
measure: Secondary Endpoint 4
timeFrame: 6 months post intervention
measure: Secondary Endpoint 5
timeFrame: 6 months post intervention
measure: Secondary Endpoint 6
timeFrame: 6 months post intervention
measure: Secondary Endpoint 7
timeFrame: 6 months post intervention
measure: Secondary Endpoint 8
timeFrame: 6 months post intervention
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Health
state: Utah
Study officials:
affiliation: Intermountain Health
name: Anthony Beutler, MD
role: PRINCIPAL_INVESTIGATOR
References: