Remote and In-person Supervised Exercise in Patients with Knee Osteoarthritis (RISE-KOA): study protocol for a non-inferiority randomized controlled trial.

Abstract

Background: Knee Osteoarthritis is a prevalent joint condition resulting in years lived with disability. A first-line treatment recommended by clinical guidelines is the therapeutic exercise to control pain and improve physical function. One possible approach for exercise supervision is telehealth using video calls, as it can be an effective alternative to in-person physical therapy for treating musculoskeletal conditions, expanding community access to physical rehabilitation. In this scenario, this study will investigate whether a muscle-strengthening exercise program for the lower limbs supervised remotely via video calls is as effective as the same exercise applied in person for improving condition-specific patient-reported outcomes (PROMs), psychological well-being, sleep quality, functional performance, and quadriceps muscle architecture. Methods: A RISE-KOA study is a parallel, two-armed, single-blinded protocol for a non-inferiority randomized controlled trial. Sixty-eight participants aged 45 years or more, with a symptomatic and radiographic diagnosis of unilateral or bilateral knee OA (grade II or III according to Kellgren & Lawerence) will be randomly assigned to a remote exercise group supervised by video calls or in-person exercise group supervised at a physiotherapy clinic. Both groups will receive the same muscle-strengthening exercises for the lower extremities for 12 weeks. Follow-ups will be conducted during treatment (6 weeks), after treatment (12 weeks), and 18 weeks after randomization. The primary outcomes will be pain intensity and physical function during (6 weeks) and after treatment (12 weeks). Secondary outcomes will be condition-specific PROMs, psychological well-being, sleep quality, functional performance, and quadriceps muscle architecture. Discussion: We hypothesize that muscle strengthening exercise supervised remotely via videocalls willnot be inferior to in-person exercise at a physiotherapy clinic on primary and secondary outcomes in patients with knee OA. Trial registration: The study was prospectively registered at ClinicalTrials.gov (NCT06101797. Registered on Oct 26, 2023).