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

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

doi:10.1186/s12891-019-2627-8

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

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

Authors

Kelli D Allen^{1

2}, Dennis Bongiorni³, Kevin Caves⁴, Cynthia J Coffman^{5

6}, Theresa A Floegel⁷, Heather M Greysen⁸, Katherine S Hall^{9

10

11}, Bryan Heiderscheit¹², Helen M Hoenig^{3

9

10}, Kim M Huffman^{3

13}, Miriam C Morey^{9

10

11}, Shalini Ramasunder¹⁴, Herbert Severson¹⁵, Battista Smith⁵, Courtney Van Houtven^{5

16}, Sandra Woolson⁵

Affiliations

¹ Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Healthcare System HSRD (152), 508 Fulton Street, Durham, NC, 27705, USA. kdallen@email.unc.edu.
² Department of Medicine & Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, USA. kdallen@email.unc.edu.
³ Physical Medicine & Rehabilitation Service, Durham VA Healthcare System, Durham, USA.
⁴ Department of Biomedical Engineering, Duke University, Durham, USA.
⁵ Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Healthcare System HSRD (152), 508 Fulton Street, Durham, NC, 27705, USA.
⁶ Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, USA.
⁷ College of Nursing, East Carolina University, Greenville, USA.
⁸ University of Pennsylvania, School of Nursing, Philadelphia, PA, USA.
⁹ Department of Medicine, Division of Geriatrics, Duke University, Durham, USA.
¹⁰ Claude D Pepper Older Americans Independence Center, Duke University, Durham, USA.
¹¹ Geriatric Research, Education and Clinical Center, Durham VA Healthcare System, Durham, USA.
¹² Department of Orthopedics and Rehabilitation, University of Wisconsin, Madison, USA.
¹³ Department of Medicine, Division of Rheumatology, Duke University, Durham, USA.
¹⁴ Orthopedic Surgery Service, Durham VA Healthcare System, Durham, USA.
¹⁵ Oregon Research Institute, Eugene, OR, USA.
¹⁶ Department of Population Health Sciences, Duke University School of Medicine, Durham, USA.

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.

Publication types

Clinical Trial Protocol

MeSH terms

Adult
Cost-Benefit Analysis
Exercise Therapy / economics
Exercise Therapy / methods*
Female
Humans
Male
Osteoarthritis, Knee / diagnosis
Osteoarthritis, Knee / therapy*
Patient-Centered Care / economics
Patient-Centered Care / methods*
Quality-Adjusted Life Years
Randomized Controlled Trials as Topic
Severity of Illness Index
Treatment Outcome
United States
United States Department of Veterans Affairs
Veterans
Young Adult

Associated data

ClinicalTrials.gov/NCT02653768

Abstract

Publication types

MeSH terms

Associated data

Grants and funding