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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2019

Open Access 01-12-2019 | Knee Osteoarthritis | Study protocol

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

Authors: Kelli D. Allen, Dennis Bongiorni, Kevin Caves, Cynthia J. Coffman, Theresa A. Floegel, Heather M. Greysen, Katherine S. Hall, Bryan Heiderscheit, Helen M. Hoenig, Kim M. Huffman, Miriam C. Morey, Shalini Ramasunder, Herbert Severson, Battista Smith, Courtney Van Houtven, Sandra Woolson

Published in: BMC Musculoskeletal Disorders | Issue 1/2019

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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.
Appendix
Available only for authorised users
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Metadata
Title
STepped exercise program for patients with knee OsteoArthritis (STEP-KOA): protocol for a randomized controlled trial
Authors
Kelli D. Allen
Dennis Bongiorni
Kevin Caves
Cynthia J. Coffman
Theresa A. Floegel
Heather M. Greysen
Katherine S. Hall
Bryan Heiderscheit
Helen M. Hoenig
Kim M. Huffman
Miriam C. Morey
Shalini Ramasunder
Herbert Severson
Battista Smith
Courtney Van Houtven
Sandra Woolson
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2019
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-019-2627-8

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