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Behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement (PEP-TALK): study protocol for a pragmatic randomised controlled trial
  1. Toby O Smith1,2,
  2. Scott Parsons1,
  3. Beth Fordham1,
  4. Alexander Ooms1,3,
  5. Susan Dutton1,3,4,
  6. Caroline Hing5,
  7. Vicki S Barber1,3,
  8. May Ee Png1,3,
  9. Sarah Lamb6
  10. on behalf of the PEP-TALK Trial Collaborators
    1. 1Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
    2. 2Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK
    3. 3Oxford Clinical Trials Unit, University of Oxford, Oxford, UK
    4. 4CSM, University of Oxford, Oxford, UK
    5. 5University of London St George's Molecular and Clinical Sciences Research Institute, London, UK
    6. 6College of Medicine and Health Sciences, University of Exeter, Exeter, Devon, UK
    1. Correspondence to Dr Toby O Smith; toby.smith{at}ndorms.ox.ac.uk

    Abstract

    Introduction While total hip replacement (THR) and total knee replacement (TKR) successfully reduce pain associated with chronic joint pathology, this infrequently translates into increased physical activity. This is a challenge given that over 50% of individuals who undergo these operations are physically inactive and have medical comorbidities such as hypertension, heart disease, diabetes and depression. The impact of these diseases can be reduced with physical activity. This trial aims to investigate the effectiveness of a behaviour change physiotherapy intervention to increase physical activity compared with usual rehabilitation after THR or TKR.

    Methods and analysis The PEP-TALK trial is a multicentre, open-labelled, pragmatic randomised controlled trial. 260 adults who are scheduled to undergo a primary unilateral THR or TKR and are moderately inactive or inactive, with comorbidities, will be recruited across eight sites in England. They will be randomised post-surgery, prior to hospital discharge, to either six, 30 min weekly group-based exercise sessions (control), or the same six weekly, group-based, exercise sessions each preceded by a 30 min cognitive behaviour approach discussion group. Participants will be followed-up to 12 months by postal questionnaire. The primary outcome is the University of California, Los Angeles (UCLA) Physical Activity Score at 12 months. Secondary outcomes include: physical function, disability, health-related quality of life, kinesiophobia, perceived pain, self-efficacy and health resource utilisation.

    Ethics and dissemination Research ethics committee approval was granted by the NRES Committee South Central (Oxford B - 18/SC/0423). Dissemination of results will be through peer-reviewed, scientific journals and conference presentations.

    Trial registration number ISRCTN29770908.

    • adult orthopaedics
    • hip
    • knee
    https://creativecommons.org/licenses/by/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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    Footnotes

    • Twitter @tobyosmith, @bethanyfordham

    • Collaborators The PEP-TALK Trial Collaborators: Mr Steve Algar (Banbury, PPI Representative), Dr Zara Hansen (ZH) (University of Oxford), Professor Karen Barker (Principal Investigator - Oxford University Hospital NHS Foundation Trust (OUH), Mr Ian Smith (Principal Investigator - Lewisham and Greenwich University Hospitals NHS Foundation Trust), Professor Iain McNamara (Principal Investigator (Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH) & Spire Norwich), Mr Michael Dunn (Principal Investigator - St George’s University Hospital NHS Foundation Trust), Mrs Dawn Lockey (Principal Investigator - City Hospitals Sunderland NHS Foundation Trust), Mr Sonny Driver (Principal Investigator – North Middlesex University Hospital NHS Trust), Mrs Jamila Kassam (Barts Health NHS Trust), Mr Peter Penny (Norwich Spire, Norwich), Mrs Celia Woodhouse, Mrs Tracey Potter and Mrs Helena Daniell (NNUH), Mr Alex Herring and Mrs Yan Cunningham (City Hospitals Sunderland NHS Foundation Trust), Irrum Afzal (South West London Elective Orthopaedic Centre), Mr Maninderpal Matharu (Barts Health NHS Trust) and Mrs Tamsin Hughes, Ms Erin Hannink and Mrs Michelle Moynihan (OUH). Oversight Committee Membership: TSC Members: Professor David Deehan (Newcastle University), Dr Emma Godfrey (Kings College London), Dr Neil Artz (University of the West of England), Mr Steve Algar (PPI representative). DSMC Members: Dr Lindsey Smith (University of the West of England & Weston Area Health NHS Trust), Dr Dipesh Mistry (University of Warwick) and Mr Paul Baker (South Tees Hospital NHS Foundation Trust).

    • Contributors TS, BF, SD, SL, AO, CH, VB and SP researched the topic and devised the study. TS, SP, AO, BF, SD, CH, VB, MEP and SL provided the first draft of the manuscript. AO and SD provided statistical oversight. TS, SP, BF, AO, SD, CH, VB, MEP and SL contributed equally to manuscript preparation. TS acts as a guarantor.

    • Funding The research is supported by the National Institute for Health Research (NIHR) Research for Patient Benefit grant (PB-PG-1216-20008). Trial Sponsor: University of Oxford, Clinical Trials and Research Governance Team, Joint Research Office, 1st floor, Boundary Brook House, Churchill Drive, Headington, Oxford OX3 7GB; email: ctrg@admin.ox.ac.uk.

    • Disclaimer TS is supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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