Live and Interactive Fitness Training Program (Vivo Knee OA)
ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-85
SponsorIntermountain Health Care, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
55-85 years of age
Diagnosis of Osteoarthritis within the prior 6 months
Pain in the knee(s) on most days of the month
walking ¼ of a mile
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Vivo Online Exercise Program
Other interventionVirtual online exercise programs conducted by the Vivo team consisting of multiple time a week group live programs
Medbridge Home program
Other interventionAt home exercise program accessed through exercise descriptions and short vidoes
Treatment groups
334 Participants
are divided into 2 treatment groupsGroup A: Vivo Online Exercise programExperimental treatment 1 intervention
Group B: Medbridge Home Exercise ProgramActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Endpoint 1
Changes from baseline in number of chair stands done in 30-seconds at 3 and 6 months.
Time frame
6 months post interventionSecondary outcomes
1
Secondary Endpoint 1
Changes from baseline in WOMAC score at 3 and 6 months.
Time frame
6 months post intervention2
Secondary Endpoint 2
Changes from baseline in length of time (seconds) to do 1-leg balance stance at 3 and 6 months.
Time frame
6 months post intervention3
Secondary Endpoint 3
Changes from baseline in seconds to complete the 8-foot up and go at 3 and 6 months.
Time frame
6 months post intervention4
Secondary Endpoint 4
Changes from baseline in number of knee raises completed in 2-minute knee raise at 3 and 6 months
Time frame
6 months post interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Intermountain Health Care, Inc.
Lead sponsor
Impactiv, Inc.
Collaborator
Source ClinicalTrials.gov