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Smith, Toby O. 
ORCID: https://orcid.org/0000-0003-1673-2954, Parsons, Scott, Ooms, Alex, Dutton, Susan, Fordham, Bethany, Garrett, Angela, Hing, Caroline and Lamb, Sallie
and
PEP-TALK Trial Collaborators
(2022)
Randomised controlled trial of a behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement: the PEP-TALK trial.
BMJ Open, 12 (5).
ISSN 2044-6055
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Abstract
OBJECTIVE: To test the effectiveness of a behaviour change physiotherapy intervention to increase physical activity compared with usual rehabilitation after Total Hip Replacement (THR) or Total Knee Replacement (TKR). DESIGN: Multicentre, pragmatic, two-arm, open, randomised controlled, superiority trial SETTING National Health Service providers in nine English hospitals. PARTICIPANTS: 224 individuals aged >18 years, undergoing a primary THR or TKR deemed “moderately inactive” or “inactive”. INTERVENTION: Participants received either six, 30-minute, weekly, group-based exercise sessions (usual care), or the same six-weekly, group-based, exercise sessions each preceded by a 30-minute cognitive behaviour discussion group aimed at challenging barriers to physical inactivity following surgery (experimental). RANDOMISATION & BLINDING: Initial 75 participants were randomised 1:1 before changing the allocation ratio to 2:1 (experimental:usual care). Allocation was based on minimisation, stratifying on comorbidities, operation type and hospital. There was no blinding. MAIN OUTCOME MEASURES: Primary: UCLA Activity Score at 12 months. Secondary: six and 12 month assessed function, pain, self-efficacy, kinesiophobia, psychological distress and quality of life. RESULTS: Of the 1254 participants assessed for eligibility, 224 were included (139 experimental:85 usual care). Mean age was 68.4 years (standard deviation: 8.7), 63% were female, 52% underwent TKR. There was no between-group difference in UCLA score (mean difference: -0.03 (95% CI: -0.52 to 0.45, p=0.89)). There were no differences observed in any of the secondary outcomes at six or 12 months. There were no important adverse events in either group. The COVID-19 pandemic contributed to the reduced intended sample size (target 260) and reduced intervention compliance. CONCLUSIONS: There is no evidence to suggest attending usual care physiotherapy sessions plus a group-based behaviour change intervention differs to attending usual care physiotherapy alone. As the trial could not reach its intended sample size, nor a proportion of participants receive their intended rehabilitation, this should be interpreted with caution.
| Item Type: | Article |
|---|---|
| Additional Information: | Data availability statement: Data are available upon reasonable request. Access to the de-identified dataset for purposes of research other than this study, would be at the discretion of the Chief Investigator, Dr Toby Smith and OCTRU. Requests for the de-identified dataset generated during the current study should be made to the Chief Investigator, Dr Toby Smith (email: toby.smith@uea.ac.uk) or OCTRU (octrutrialshub@ndorms.ox.ac.uk). Dr Toby Smith and OCTRU will consider requests once the main results from the study have been published up until 31 December 2026. Funding: The research is supported by the National Institute for Health Research (NIHR) Research for Patient Benefit grant (PB-PG-1216-20008). 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. |
| Uncontrolled Keywords: | arthroplasty,osteoarthritis,rehabilitation,physical activity,exercise,cognitive behavioural,knee,adult orthopaedics,rheumatology,hip,medicine(all) ,/dk/atira/pure/subjectarea/asjc/2700 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > School of Health Sciences |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Centres > Population Health |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 05 Apr 2022 16:30 |
| Last Modified: | 19 Oct 2023 03:18 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/84484 |
| DOI: | 10.1136/bmjopen-2022-061373 |
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