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| Name | Class |
|---|---|
| Impactiv, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivo Online Exercise program | Experimental |
| |
| Medbridge Home Exercise Program | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivo Online Exercise Program | Other | Virtual online exercise programs conducted by the Vivo team consisting of multiple time a week group live programs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint 1 | Changes from baseline in number of chair stands done in 30-seconds at 3 and 6 months. | 6 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint 1 | Changes from baseline in WOMAC score at 3 and 6 months. | 6 months post intervention |
| Secondary Endpoint 2 | Changes from baseline in length of time (seconds) to do 1-leg balance stance at 3 and 6 months. |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amelia Millward | Contact | 801-507-8095 | amelia.millward@imail.org |
| Name | Affiliation | Role |
|---|---|---|
| Anthony Beutler, MD | Intermountain Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Health | Recruiting | Murray | Utah | 84107 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Medbridge Home program | Other | At home exercise program accessed through exercise descriptions and short vidoes |
|
| 6 months post intervention |
| Secondary Endpoint 3 | Changes from baseline in seconds to complete the 8-foot up and go at 3 and 6 months. | 6 months post intervention |
| Secondary Endpoint 4 | Changes from baseline in number of knee raises completed in 2-minute knee raise at 3 and 6 months | 6 months post intervention |
| Secondary Endpoint 5 | Changes from baseline in number of arm-curls done in 30 seconds at 3 and 6 months | 6 months post intervention |
| Secondary Endpoint 6 | Changes from baseline in PROMIS-Plus-Osteoarthritis of the Knee (OAK) score at 3 and 6 months | 6 months post intervention |
| Secondary Endpoint 7 | Changes from baseline in exercise self-efficacy scale score at 3 and 6 months | 6 months post intervention |
| Secondary Endpoint 8 | Changes from baseline in quality of life (SF-36 score) at 3 and 6 months | 6 months post intervention |
| D012216 |
| Rheumatic Diseases |