Add like
Add dislike
Add to saved papers

Protocol for a randomised feasibility trial comparing a combined program of education and exercise versus general advice for ankle osteoarthritis.

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 .

Full text links

We have located links that may give you full text access.
Can't access the paper?
Try logging in through your university/institutional subscription. For a smoother one-click institutional access experience, please use our mobile app.

Related Resources

For the best experience, use the Read mobile app

Mobile app image

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app

All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.

By using this service, you agree to our terms of use and privacy policy.

Your Privacy Choices Toggle icon

You can now claim free CME credits for this literature searchClaim now

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app