STepped exercise program for patients with knee OsteoArthritis (STEP-KOA): protocol for a randomized controlled trial

ECU Author/Contributor (non-ECU co-authors, if there are any, appear on document)
Kelli D Allen (Creator)
Dennis Bongiorni (Creator)
Kevin Caves (Creator)
Cynthia J Coffman (Creator)
Theresa A Floegel (Creator)
Heather M Greysen (Creator)
Katherine S Hall (Creator)
Bryan Heiderscheit (Creator)
Helen M Hoenig (Creator)
Kim M Huffman (Creator)
Miriam C Morey (Creator)
Shalini Ramasunder (Creator)
Herbert Severson (Creator)
Battista Smith (Creator)
Courtney Van Houtven (Creator)
Sandra Woolson (Creator)
Institution
East Carolina University (ECU )
Web Site: http://www.ecu.edu/lib/

Abstract: Abstract Background Physical therapy (PT) and other exercise-based interventions are core components of care for knee osteoarthritis (OA) , but both are underutilized , and some patients have limited access to PT services. This clinical trial is examining a STepped Exercise Program for patients with Knee OsteoArthritis (STEP-KOA). This model of care can help to tailor exercise-based interventions to patient needs and also conserve higher resource services (such as PT) for patients who do not make clinically relevant improvements after receiving less costly interventions. Methods / Design Step-KOA is a randomized trial of 345 patients with symptomatic knee OA from two Department of Veterans Affairs sites. Participants are randomized to STEP-KOA and Arthritis Education (AE) Control groups with a 2:1 ratio , respectively. STEP-KOA begins with 3 months of access to an internet-based exercise program (Step 1). Participants not meeting response criteria for clinically meaningful improvement in pain and function after Step 1 progress to Step 2 , which involves bi-weekly physical activity coaching calls for 3€‰months. Participants not meeting response criteria after Step 2 progress to in-person PT visits (Step 3). Outcomes will be assessed at baseline , 3 , 6 and 9€‰months (primary outcome time point). The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) , and secondary outcomes are objective measures of physical function. Linear mixed models will compare outcomes between the STEP-KOA and AE control groups at follow-up. We will also evaluate patient characteristics associated with treatment response and conduct a cost-effectiveness analysis of STEP-KOA. Discussion STEP-KOA is a novel , efficient and patient-centered approach to delivering exercise-based interventions to patients with knee OA , one of the most prevalent and disabling health conditions. This trial will provide information on the effectiveness of STEP-KOA as a novel potential model of care for treatment of OA. Trial Registration Clinicaltrials.gov , NCT02653768 (STepped Exercise Program for Knee OsteoArthritis (STEP-KOA)) , Registered January 12 , 2016.

Additional Information

Publication
Other
Allen et al. 2019. STepped exercise program for patients with knee OsteoArthritis (STEP-KOA): protocol for a randomized controlled trial. BMC Musculoskeletal Disorders. 20:254 https://doi.org/10.1186/s12891-019-2627-8
Language: English
Date: 2019
Keywords
Osteoarthritis, Physical therapy, knee, Exercise
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STepped exercise program for patients with knee OsteoArthritis (STEP-KOA): protocol for a randomized controlled trialhttp://hdl.handle.net/10342/7179The described resource references, cites, or otherwise points to the related resource.