Comparing an Expanded Versus Brief Telehealth Physical Therapist Intervention for Knee Osteoarthritis: Study Protocol for the Delaware PEAK Randomized Controlled Trial

Abstract Objective The purpose of this study is to investigate whether a remotely delivered physical therapist intervention increases physical activity (PA) over 12 weeks, compared with existing web-based resources, in adults with knee osteoarthritis (OA). Methods This will be a single-center, randomized controlled trial with 2 parallel arms: (1) the Expanded Intervention (Delaware PEAK [Physical Exercise and Activity for Knee osteoarthritis]), which includes five 45- to 60-minute video conference-based sessions of supervised exercise (strengthening exercises, step goals) that are remotely delivered over 12 weeks by a physical therapist; or (2) the Brief Intervention (control group), a website that includes prerecorded videos directing participants to web-based resources for strengthening, PA, and pain management for knee OA that are freely available. The trial will enroll 100 participants who meet the National Institute for Health and Care Excellence OA clinical criteria (≥45 years old, have activity-related knee pain, and have no morning stiffness or it lasts ≤30 minutes), reside in the contiguous United States (excluding Alaska and Hawaii), and are seeking to be more physically active. Outcomes include PA (time in moderate-to-vigorous and light PA, steps per day), sedentary behaviors, treatment beliefs, and self-efficacy for exercise. Our primary outcome is moderate-to-vigorous PA. Outcomes will be measured at baseline, 12 weeks, and 24 weeks. Impact This protocol focuses on the remote delivery of physical therapy via telehealth to adults with knee OA and comes at a critical time, because the burden of inactivity is of particular concern in this population. If successful, the findings of this work will provide strong support for the broad implementation of Delaware PEAK, highlight the utility of telehealth in physical therapy, and address the critical need to utilize exercise to manage adults with knee OA through physical therapists.