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. 2019 May 28;20(1):254.
doi: 10.1186/s12891-019-2627-8.

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

Kelli D Allen  1   2 , Dennis Bongiorni  3 , Kevin Caves  4 , Cynthia J Coffman  5   6 , Theresa A Floegel  7 , Heather M Greysen  8 , Katherine S Hall  9   10   11 , Bryan Heiderscheit  12 , Helen M Hoenig  3   9   10 , Kim M Huffman  3   13 , Miriam C Morey  9   10   11 , Shalini Ramasunder  14 , Herbert Severson  15 , Battista Smith  5 , Courtney Van Houtven  5   16 , Sandra Woolson  5
Affiliations

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

Kelli D Allen et al. BMC Musculoskelet Disord. .

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.

Keywords: Exercise; Knee; Osteoarthritis; Physical therapy.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study Design
Fig. 2
Fig. 2
Sample Screen Shots from the Internet-Based Exercise Training Program (Used with permission from Visual Health Information (VHI)
See this image and copyright information in PMC

References

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