# STepped Exercise Program for Knee Osteoarthritis: The STEP-KOA Study

> **NIH NIH R34** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2024 · $284,709

## Abstract

Knee osteoarthritis (OA) is a leading cause of pain and disability. Exercise is a first-line component of care for
knee OA. However, the majority of individuals with knee OA are inactive, and exercise-based physical therapy
(PT) is underutilized across health care systems. There are no established processes or pathways for
systematically integrating exercise-based therapies into clinical care for knee OA; this is a major contributor to
underutilization. We recently developed and tested a STepped Exercise Program for Knee OA (STEP-KOA) as
a systematic approach to delivering exercise-based therapies. STEP-KOA begins with a home-based exercise
program, supported by evidence-based and behaviorally informed tools (Step 1). After 3 months, patients are
evaluated for clinically meaningful improvement in pain and function; patients not meeting criteria for
improvement “step up” to telephone-based coaching (Step 2). After an additional 3 months, patients still not
meeting criteria for clinically relevant improvement progress to PT visits (Step 3). Patient-centeredness and
efficiency are hallmarks of STEP-KOA, as the interventions are based on patient needs and improvement, and
the more resource-intensive interventions (particularly PT) are reserved for later stages. In our randomized
controlled trial conducted within the Department of Veterans Affairs Healthcare System, STEP-KOA resulted in
significant improvements in self-reported pain and function compared with an Arthritis Education control group.
We are preparing to conduct a multi-site hybrid type 1 effectiveness-implementation randomized controlled trial
(RCT) that will take important steps toward enhancing and implementing STEP-KOA in different health
systems. We will add physical activity monitoring, behavioral messaging and tailored exercise prescriptions
(that emphasize progression to ensure a sufficient training response) to STEP-KOA. We specifically plan for a
2-site RCT in which individuals with symptomatic knee OA are randomized to STEP-KOA or a usual care / wait
list control group., with outcomes collected at baseline, 9 months (end of intervention period) and 15 months
(6-month maintenance period). In this planning period, we will: 1) Finalize the scientific details and
intervention tools for the multi-site STEP-KOA RCT; this will include enhancing the STEP-KOA patient tools
to incorporate the new components, refining tools for STEP-KOA coaches and physical therapists, finalizing
training materials and fidelity assessment plans, establishing procedures for telehealth delivery of PT visits,
finalizing assessment plans, and establishing the randomization scheme and statistical analysis plan. 2)
Finalize the logistical and practical aspects of the multi-site STEP-KOA RCT; this will include identifying
referring clinics and PT clinics, addressing regulatory and logistical details, building the study database and
developing data management plans, finalizing recruitment and enrollment processes,...

## Key facts

- **NIH application ID:** 10876781
- **Project number:** 1R34AR083077-01A1
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Kelli D. Allen
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $284,709
- **Award type:** 1
- **Project period:** 2024-04-01 → 2025-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10876781

## Citation

> US National Institutes of Health, RePORTER application 10876781, STepped Exercise Program for Knee Osteoarthritis: The STEP-KOA Study (1R34AR083077-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10876781. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*