Introduction Knee osteoarthritis (OA) is the most common chronic illness among older adults. Up to the submission date of this protocol, there are no published UK studies reporting the efficacy of a combined intervention programme of physical activity and dietary restriction on the musculoskeletal function of obese older adults with knee OA in spite of the clinical recommendation for exercise and diet for people with knee OA. The aim of this study is to assess the feasibility and acceptability of a combined dietary restriction and physical activity intervention programme and collect preliminary data.
Method and analysis This single-arm intervention study is scheduled to begin in September 2017 and conclude in November 2018. It will take place at the Royal Orthopaedic Hospital (ROH), Birmingham and the School of Sport, Exercise and Rehabilitation Sciences (SportExR), University of Birmingham. Participants will receive a physiotherapy usual care programme for knee OA for 1 month, after which they will continue to exercise in their local gym/leisure facility for 3 months. Participants will also follow dietary restriction throughout the 4-month intervention. Mixed analysis techniques will be used to analyse the quantitative and qualitative outcome measures.
Ethics and dissemination It is approved by ROH R&D Foundation Trust and the Health Research Authority. The Consort Guidelines and checklist will be reviewed prior to generating any publications for the trial to ensure they meet the standards required for submission to high-quality peer-reviewed journals.
Trial registration number ISRCTN12906938.
- knee osteoarthritis
- older adults
- feasibility trials
- usual care
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
Contributors ASA prepared the first draft of the manuscript that has been reviewed and approved by CAG before circulating it to all coauthors. ABR, GB and FP had critically revised the manuscript and provided their input before submission for publication. All the coauthors have been involved in the study design and developing the protocol.
Funding This work is supported by the UoB which is part of a PhD studentship award to Ms Alrushud PhD who is funded by the Saudi Arabian Cultural Bureau, London and King Saud University, Saudi Arabia.
Competing interests None declared.
Patient consent Obtained.
Ethics approval The study is approved by the West Midlands-Solihull Research Ethics Committee, REC ref: 17/WM/0122, protocol number ERN_16-1432; RG_17-024, and V.6.0 approved on 10 January 2018 by HRA and the ROH R&D Foundation Trust.
Provenance and peer review Not commissioned; externally peer reviewed.
Author note The protocol was developed by the CI and her supervisor and reviewed by the coinvestigators which include qualified medical staff at ROH. This is a low-risk study which has received peer review from the student supervisors plus independent peer review by ROH R&D Dept and an academic colleague (Dr Leigh Breen, SportExR).
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.