Michelle D Smith, Viana Vuvan, Natalie J Collins, David J Hunter, Nathalia Costa, Melinda M Franettovich Smith, Bill Vicenzino
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引用次数: 0
Abstract
Background: Ankle osteoarthritis (OA) is a serious problem with high associated pain and disability. While education and exercise are recommended for the initial management of OA, this has not been investigated in ankle OA. The primary aim of this study is to establish the feasibility of running a full-scale randomised controlled trial (RCT) investigating a combined education and exercise program compared to a general advice program for people with ankle OA. The secondary aims are to collect preliminary data which will inform sample size calculations, and understand the perspectives of people with ankle OA on their participation in the trial.
Methods: Thirty individuals aged 35 years or older with symptomatic radiographic ankle OA will be recruited from the community and randomised to receive either a combined education and exercise program or a general advice program, both of which will be delivered by a physiotherapist in a group setting. Primary outcomes of feasibility include responses to study advertisements, number of eligible participants, recruitment rate, adherence with the intervention, fidelity of the intervention, adverse events, drop-out rate, and credibility and expectancy of the intervention. Secondary participant-reported outcomes will include global rating of change, patient acceptable symptom state, severity of ankle pain and stiffness, self-reported function, quality of life, satisfaction with treatment, and use of co-interventions. Follow up will be at 8 weeks and 3 months. Physical measures of 40 m walking speed, timed stairs descent, heel raise endurance and ankle dorsiflexion range of motion will be collected at baseline and 8 weeks. Primary feasibility outcomes will be reported descriptively, and estimates of the variability of secondary participant-reported and physical outcomes will be calculated. Semi-structured interviews will be conducted with participants to understand perspectives about the intervention and participation in the trial, with data analyzed thematically.
Discussion: Study findings will establish the feasibility of running a full-scale RCT to investigate a combined education and exercise program compared to a general advice program for people with ankle OA. This study is a necessary first step to advance the international research agenda of evaluating the efficacy of exercise in the management of ankle OA.
Trial registration: ACTRN12623000017628. Registered 10 January 2023, https://www.anzctr.org.au/ACTRN12623000017628.aspx .
期刊介绍：
Journal of Foot and Ankle Research, the official journal of the Australian Podiatry Association and The College of Podiatry (UK), is an open access journal that encompasses all aspects of policy, organisation, delivery and clinical practice related to the assessment, diagnosis, prevention and management of foot and ankle disorders.
Journal of Foot and Ankle Research covers a wide range of clinical subject areas, including diabetology, paediatrics, sports medicine, gerontology and geriatrics, foot surgery, physical therapy, dermatology, wound management, radiology, biomechanics and bioengineering, orthotics and prosthetics, as well the broad areas of epidemiology, policy, organisation and delivery of services related to foot and ankle care.
The journal encourages submissions from all health professionals who manage lower limb conditions, including podiatrists, nurses, physical therapists and physiotherapists, orthopaedists, manual therapists, medical specialists and general medical practitioners, as well as health service researchers concerned with foot and ankle care.
The Australian Podiatry Association and the College of Podiatry (UK) have reserve funds to cover the article-processing charge for manuscripts submitted by its members. Society members can email the appropriate contact at Australian Podiatry Association or The College of Podiatry to obtain the corresponding code to enter on submission.
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