Live and Interactive Fitness Training Program (Vivo Knee OA)

NCT06462560 | Recruiting

• 1 other identifier: 1052693
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint 1

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

  6 months post intervention

Secondary Outcomes (8)

• Secondary Endpoint 1

  6 months post intervention

• Secondary Endpoint 2

  6 months post intervention

• Secondary Endpoint 3

  6 months post intervention

• Secondary Endpoint 4

  6 months post intervention

• Secondary Endpoint 5

  6 months post intervention

Study Arms (2)

Vivo Online Exercise program

EXPERIMENTAL

Other: Vivo Online Exercise Program

Medbridge Home Exercise Program

ACTIVE COMPARATOR

Other: Medbridge Home program

Interventions

Vivo Online Exercise Program OTHER

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

Vivo Online Exercise program

Medbridge Home program OTHER

At home exercise program accessed through exercise descriptions and short vidoes

Medbridge Home Exercise Program

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Impactiv, Inc.: collaborator

Study Sites (1)

Intermountain Health

Murray, Utah, 84107, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Anthony Beutler, MD

  Intermountain Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amelia Millward

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: April 28, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)