Randomised controlled trial of a behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement: the PEP-TALK trial

Autor: Michael Dunn, Beth Fordham, Karen Barker, Scott Parsons, Susan Dutton, Sarah Lamb, Jamila Kassam, Toby O Smith, Iain McNamara, Alexander Ooms, Caroline Hing, Steve Algar, Zara Hansen, Sonny Driver, Peter Penny, Celia Woodhouse, Tracey Potter, Helena Daniell, Alex Herring, Yan Cunningham, Irrum Afzal, Maninderpal Matharu, Tamsin Hughes, Erin Hannink, Michelle Moynihan, Angela Garrett, Ian Smith, Vicki Barber, Malcolm Hart, MayEe Png, Dawn Lockey
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: BMJ Open, Vol 12, Iss 5 (2022)
Druh dokumentu: article
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2022-061373
Popis: 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 min, weekly, group-based exercise sessions (usual care) or the same six weekly, group-based, exercise sessions each preceded by a 30 min cognitive behaviour discussion group aimed at challenging barriers to physical inactivity following surgery (experimental).Randomisation and 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: University of California Los Angeles (UCLA) Activity Score at 12 months. Secondary: 6 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 (SD: 8.7), 63% were women, 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 6 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.Trial registration number ISRCTN29770908.
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