Behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement (PEP-TALK): study protocol for a pragmatic randomised controlled trial
Michael Dunn,
Beth Fordham,
May Ee Png,
Scott Parsons,
Sarah Lamb,
Jamila Kassam,
Toby O Smith,
Dipesh Mistry,
Vicki S Barber,
Paul Baker,
Iain McNamara,
Alexander Ooms,
Caroline Hing,
Steve Algar,
Zara Hansen,
Ian Smith Karen,
Dawn Locke,
Sonny Driver,
Peter Penny,
Celia Woodhouse,
Tracey Potter,
Helena Daniell,
Alex Herring,
Yan Cunningham,
Irrum Afzal,
Maninderpal Matharu,
Tamsin Hughes,
Erin Hannink,
Michelle Moynihan,
David Deehan,
Emma Godfrey,
Neil Artz,
Lindsey Smith
Affiliations
Michael Dunn
School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK
Beth Fordham
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
May Ee Png
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
Scott Parsons
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
Sarah Lamb
College of Medicine and Health, University of Exeter, Exeter, UK
Jamila Kassam
Toby O Smith
Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK
Dipesh Mistry
Warwick Clinical Trials Unit, University of Warwick, Coventry, UK
Vicki S Barber
8 Oxford Clinical Trials Unit, Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford Nuffield, Oxford, UK
Paul Baker
Department of Health Sciences, University of York, York, UK
Iain McNamara
Alexander Ooms
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Disorders, University of Oxford, Oxford, UK
Caroline Hing
Trauma and Orthopaedic Department, St George`s University Hospitals NHS Foundation Trust, London, UK
Steve Algar
Zara Hansen
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford University, Oxford, UK
Ian Smith Karen
Dawn Locke
Sonny Driver
Peter Penny
Celia Woodhouse
Tracey Potter
Helena Daniell
Alex Herring
Yan Cunningham
Irrum Afzal
Maninderpal Matharu
Tamsin Hughes
Erin Hannink
Physiotherapy Research Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
Michelle Moynihan
David Deehan
Newcastle Upon Tyne Hospitals NHS Trust, Newcastle Upon Tyne, UK
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.