PETKO: Pilates Exercise Training before Knee arthroplasty in patients with Osteoarthritis A two-arm, randomized, open-label assessor blinded phase II clinical trial

Abstract

Background and Aim: Osteoarthritis (OA) is as a degenerative inflammatory disease of the hyaline cartilage of the synovial joints; currently it is the most common joint disease in the world and mainly affects the knee. Total knee arthroplasty (TKA) is one of the treatment choices in the management of severe cases of OA. Pilates is a fitness system that combines different exercises with the aim for increasing flexibility, joint and core strength. It has not been reported the effects, of a pre-surgical Pilates intervention, on the post-operative evaluation of the quality of life, in patients with a TKA. Therefore, we present a study protocol designed to evaluate the effects, on the activities of daily living (ADL), of a Pilates routine done prior to a TKA, in patients over 60 years of age with severe OA; compared to a pre-surgical intervention of educational sessions. Methods: The PETKO trial is designed to be a single center, two-arm, open-label assessor blinded, randomized controlled trial. A total of 86 patients with an indication for TKA will be randomized in a 1:1 allocation ratio. The experimental arm will receive 18 preoperative sessions of Pilates and educational sessions in a six-week period; while the comparator arm will only receive the educational sessions during the same period. The primary outcome will be the ADL measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS) ADL subscale at the 90 th day post surgery. For secondary outcomes we will evaluate the rest of the KOOS subscales, functional exercise capacity, range of motion and hospital length of stay. Discussion: There is a direct relationship between functional status and morbidity and mortality in geriatric patients. The effect of Pilates has been studied in elderly patients in observational studies and has shown improvements in flexibility and strength; that is why we hypothesized that an improvement in the baseline condition of the patients with knee OA, prior to the surgical intervention, may have a direct benefit in the recovery time and on their quality of life, in a long term. The PETKO trial has de advantage that is a well designed RCT that will evaluate a non-common intervention in a way that has not been evaluated yet.