Exercise-therapy and education for knee osteoarthritis: comparison of telerehabilitation with face-to-face delivery

This RCT aligns with the SPIRIT (Chan et al, 2013; Calvert et al, 2018), and Australian Good Clinical Practice guidelines. Participants with knee OA will be recruited via the Musculoskeletal Australia help line (https://www.msk.org.au/) (project partner) or other social media channels. Eligibility will be determined via telephone and online screening. 110 eligible participants will be randomised on a 1:1 basis (computer random number generator) to either a face-to-face (Active control group; delivered at one of more than 35 sites in Victoria) or telerehabilitation (Intervention group; delivered remotely from La Trobe University) GLA:DTM Australia exercise-therapy and education program. The telerehabilitation intervention will be delivered via the eHAB® telerehabilitation platform (NeoRehab, Brisbane, Australia), a clinically validated system that allows clinicians to provide services to their patients via real time video-conferencing into the home. GLA:DTM (Good Life with Arthritis from Denmark) Australia is an 8-week exercise-therapy and education program for people with OA, supported by evidence and clinical guidelines. Prior to study enrolment, screening and baseline assessment, including all outcome measures will occur at La Trobe University, Bundoora. Follow up assessment will involve repeat of the same outcomes measures three months following enrolment, completed again at La Trobe University, Bundoora. The program Education: Two education sessions (60-90 minutes) will focus on the latest research on OA and explain the neuromuscular exercises involved in GLA:D™ Australia. These education sessions are held at different times to the exercise-therapy sessions and typically occur prior to commencing the exercise-therapy program. However, in some instances they may occur once the exercise therapy-program has commenced (but still within the first 4 weeks), depending on time availability of the patient and actual education sessions. Education session occur on different days, typically 1 week apart. They can occur on the same day, or separate day to an exercise session dependingon time availability. Exercise-therapy: Participants attend group neuromuscular exercise therapy sessions (60 minutes) twice a week for six weeks. The exercise program is standardised but individualised and progressive. Exercises (standing up from sitting, stepping onto a step, lunging, moving leg against a resistance band, etc.) are designed to be moderately hard and ensure they do not flare any pain after the exercise session, although some pain is allowed during the session. The level of training and progression is guided by the patient's neuromuscular function (control) and pain responses during and after sessions. Further details about the program can be found here: http://nemex.trekeducation.org/ To minimise participant burden, study physiotherapists will be located at clinics across greater Melbourne. Eligibility will require participants to live within a 10km radius of a clinical site offering GLA:D Australia. Treating physiotherapists in both arms of the trial will undergo a GLA:DTM Australia Training (16-hour training session) provided by the research team. Further implementation support is provided via treatment manuals and online suppliments that have been designed by the researchers with input from experienced clinicians. To ensure fidelity of the face-to-face GLA:DTM Australia program, a clinical RA familiar with the program (but not a provider for this study) will conduct four direct observations at each physiotherapy clinic providing GLA:DTM Australia to participants over the course of the study – evaluating treatment fidelity and clinical processes based on a priori criteria developed by Davis et al. who have implemented the GLA:D® program in Canada. Our initiatives to optimise standardisation include examples of exercise videos, frequently asked questions, and being available to address queries promptly via phone/e-mail. The treating physiotherapists will record per protocol treatment and any co-interventions in a log book. REFERENCES Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ : British Medical Journal. 2013;346. Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan A-W, King MT, et al. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension. Jama. 2018;319(5):483-94