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 f...

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Autores principales: Smith, Michelle D., Vuvan, Viana, Collins, Natalie J., Hunter, David J., Costa, Nathalia, Smith, Melinda M. Franettovich, Vicenzino, Bill
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10588035/
https://www.ncbi.nlm.nih.gov/pubmed/37858226
http://dx.doi.org/10.1186/s13047-023-00669-1
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author Smith, Michelle D.
Vuvan, Viana
Collins, Natalie J.
Hunter, David J.
Costa, Nathalia
Smith, Melinda M. Franettovich
Vicenzino, Bill
author_facet Smith, Michelle D.
Vuvan, Viana
Collins, Natalie J.
Hunter, David J.
Costa, Nathalia
Smith, Melinda M. Franettovich
Vicenzino, Bill
author_sort Smith, Michelle D.
collection PubMed
description 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13047-023-00669-1.
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spelling pubmed-105880352023-10-21 Protocol for a randomised feasibility trial comparing a combined program of education and exercise versus general advice for ankle osteoarthritis Smith, Michelle D. Vuvan, Viana Collins, Natalie J. Hunter, David J. Costa, Nathalia Smith, Melinda M. Franettovich Vicenzino, Bill J Foot Ankle Res Study Protocol 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13047-023-00669-1. BioMed Central 2023-10-20 /pmc/articles/PMC10588035/ /pubmed/37858226 http://dx.doi.org/10.1186/s13047-023-00669-1 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Smith, Michelle D.
Vuvan, Viana
Collins, Natalie J.
Hunter, David J.
Costa, Nathalia
Smith, Melinda M. Franettovich
Vicenzino, Bill
Protocol for a randomised feasibility trial comparing a combined program of education and exercise versus general advice for ankle osteoarthritis
title Protocol for a randomised feasibility trial comparing a combined program of education and exercise versus general advice for ankle osteoarthritis
title_full Protocol for a randomised feasibility trial comparing a combined program of education and exercise versus general advice for ankle osteoarthritis
title_fullStr Protocol for a randomised feasibility trial comparing a combined program of education and exercise versus general advice for ankle osteoarthritis
title_full_unstemmed Protocol for a randomised feasibility trial comparing a combined program of education and exercise versus general advice for ankle osteoarthritis
title_short Protocol for a randomised feasibility trial comparing a combined program of education and exercise versus general advice for ankle osteoarthritis
title_sort protocol for a randomised feasibility trial comparing a combined program of education and exercise versus general advice for ankle osteoarthritis
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10588035/
https://www.ncbi.nlm.nih.gov/pubmed/37858226
http://dx.doi.org/10.1186/s13047-023-00669-1
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