Live and Interactive Fitness Training Program (Vivo Knee OA)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 55 Years - 85 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06462560
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Intermountain Health Care, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Anthony Beutler, MD
Principal Investigator Affiliation Intermountain Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis
Arms & Interventions

Arms

Experimental: Vivo Online Exercise program

Active Comparator: Medbridge Home Exercise Program

Interventions

Other: - Vivo Online Exercise Program

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

Other: - Medbridge Home program

At home exercise program accessed through exercise descriptions and short vidoes

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Intermountain Health, Murray, Utah

Status

Recruiting

Address

Intermountain Health

Murray, Utah, 84107

Site Contact

Amelia Millward

[email protected]

801-507-8095