Exercise Support for Knee Osteoarthritis in Veterans
Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans
Recruiting
Phase 3Interventional Study
Osteoarthritis, Knee
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 90
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
254 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for veterans with knee osteoarthritis who are starting physical therapy. Participants will receive support and encouragement to maintain their exercise routine over two years with follow-up visits.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with chronic knee osteoarthritis.
I am between 40 and 90 years old.
I am starting physical therapy for knee osteoarthritis within the next month.
I have completed at least 4 appointments with my physical therapist.
I can safely participate in ongoing exercise.
I can sync my Fitbit at least monthly.
You may not be able to join if
I do not have a smartphone that can interact with the program.
I cannot walk 2 blocks without assistance.
I have poorly controlled inflammatory arthritis.
My doctor believes my life expectancy is less than 1 year.
I have severe heart failure or unstable angina.
I have severe pain in an area other than my knee that limits daily function.
I do not speak English well enough to understand messages.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The aims are to determine whether 1) an incentive based on behaviorally-enhanced gamification and social incentives and 2) health coaching can promote adherence to exercise and physical activity after physical therapy for osteoarthritis of the knee (KOA). The research design is a randomized clinical trial with factorial design
This randomized clinical trial of 254 patients using a factorial desig…
The aims are to determine whether 1) an incentive based on behaviorally-enhanced gamification and social incentives and 2) health coaching can promote adherence to exercise and physical activity after physical therapy for osteoarthritis of the knee (KOA). The research design is a randomized clinical trial with factorial design
This randomized clinical trial of 254 patients using a factorial design will leverage a clinical trial platform developed through the University of Pennsylvania that allows for the remotely capture important patient-reported outcomes and other interaction through a participant's smart phone. The investigators will randomize participants to receive social incentives with gamification to promote adherence to prescribed exercises as well as maintenance of greater levels of physical activity and compare to controls that receive a Fitbit but no additional incentive. Participants may also be randomized to receive a health coach. The investigators will utilize mobile applications for smart phones and wearable activity trackers through the Way-to-Health platform and assess, in real time, the impact of the interventions on patient-reported function and pain (as measured by the Knee Osteoarthritis Outcome Score) as well as physical activity. Participants will be followed for 2 years, with a total of 5 in-person visits.
Knee osteoarthritis (KOA) is one of the most prevalent and disabling conditions among Veterans and accounts for high morbidity and high costs for the VA. Importantly, while physical therapy is valuable for patients with KOA, lack of adherence to home exercises and low overall physical activity limit the durability of response. The current proposal aims to address two important knowledge gaps in the management of KOA in order to improve pain and function.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Clinical diagnosis or chronic knee osteoarthritis.
* Age between 40-90 years
* Initiating physical therapy for KOA (has initial appointment within the next month or had first PT visit within the last 7 days)
* To be randomized: PT feels that they are able to safely and reliabl…
Inclusion Criteria:
* Clinical diagnosis or chronic knee osteoarthritis.
* Age between 40-90 years
* Initiating physical therapy for KOA (has initial appointment within the next month or had first PT visit within the last 7 days)
* To be randomized: PT feels that they are able to safely and reliably participate in ongoing exercise.
* To be randomized: must have completed at least 4 virtual or in-person appointments with PT
* To be randomized: must sync their Fitbit at least monthly.
Exclusion Criteria:
* Lack of a smart phone allowing interaction with the WTH platform
* Inability to walk 2 blocks without assistance
* Poorly controlled crystalline arthritis or other diagnosis of inflammatory arthritis.
* Treating provider or LSI believes life-expectancy is \<1 year
* Based on LSI or treating provider discretion: exclusions may occur for severe heart failure, unstable angina, end stage renal disease, severe chronic obstructive or other pulmonary disease, or other chronic illness felt to limit participants ability to participate in exercise or resulting in potential safety risk
* Severe pain in a non-knee area limiting daily function
* Non-English speakers or poor reading ability limiting ability to interact with text messages.
* Pregnancy
* Receiving physical therapy outside of the VA.
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