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Clinical Trials/NCT06462560
NCT06462560
Recruiting
Not Applicable

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

Intermountain Health Care, Inc.1 site in 1 country334 target enrollmentApril 28, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Intermountain Health Care, Inc.
Enrollment
334
Locations
1
Primary Endpoint
Primary Endpoint 1
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 28, 2024
End Date
April 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

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)

Outcomes

Primary Outcomes

Primary Endpoint 1

Time Frame: 6 months post intervention

Changes from baseline in number of chair stands done in 30-seconds at 3 and 6 months.

Secondary Outcomes

  • Secondary Endpoint 4(6 months post intervention)
  • Secondary Endpoint 1(6 months post intervention)
  • Secondary Endpoint 5(6 months post intervention)
  • Secondary Endpoint 7(6 months post intervention)
  • Secondary Endpoint 8(6 months post intervention)
  • Secondary Endpoint 3(6 months post intervention)
  • Secondary Endpoint 2(6 months post intervention)
  • Secondary Endpoint 6(6 months post intervention)

Study Sites (1)

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