Prehabilitation in elective patients undergoing cardiac surgery: a randomised control trial (THE PrEPS TRIAL) - a study protocol.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
05 01 2023
Historique:
entrez: 5 1 2023
pubmed: 6 1 2023
medline: 10 1 2023
Statut: epublish

Résumé

Prehabilitation prior to surgery has been shown to reduce postoperative complications, reduce length of hospital stay and improve quality of life after cancer and limb reconstruction surgery. However, there are minimal data on the impact of prehabilitation in patients undergoing cardiac surgery, despite the fact these patients are generally older and have more comorbidities and frailty. This trial will assess the feasibility and impact of a prehabilitation intervention consisting of exercise and inspiratory muscle training on preoperative functional exercise capacity in adult patients awaiting elective cardiac surgery, and determine any impact on clinical outcomes after surgery. PrEPS is a randomised controlled single-centre trial recruiting 180 participants undergoing elective cardiac surgery. Participants will be randomised in a 1:1 ratio to standard presurgical care or standard care plus a prehabilitation intervention. The primary outcome will be change in functional exercise capacity measured as change in the 6 min walk test distance from baseline. Secondary outcomes will evaluate the impact of prehabilitation on preoperative and postoperative outcomes including; respiratory function, health-related quality of life, anxiety and depression, frailty, and postoperative complications and resource use. This trial will evaluate if a prehabilitation intervention can improve preoperative physical function, inspiratory muscle function, frailty and quality of life prior to surgery in elective patients awaiting cardiac surgery, and impact postoperative outcomes. A favourable opinion was given by the Sheffield Research Ethics Committee in 2019. Trial findings will be disseminated to patients, clinicians, commissioning groups and through peer-reviewed publication. ISRCTN13860094.

Identifiants

pubmed: 36604134
pii: bmjopen-2022-065992
doi: 10.1136/bmjopen-2022-065992
pmc: PMC9827267
doi:

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e065992

Informations de copyright

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Enoch Akowuah (E)

Department of Cardiothoracic Surgery, The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, MIddlesbrough, UK enoch.akowuah@nhs.net.
South Tees Academic Cardiovascular Unit, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.
Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne, UK.

Ayesha Mathias (A)

Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.

Michelle Bardgett (M)

Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.

Samantha Harrison (S)

School of Health and Life Sciences, Teeside University, Middlesbrough, UK.

Adetayo S Kasim (AS)

Department of Anthropology, Durham University, Durham, UK.

Kirsti Loughran (K)

School of Health and Life Sciences, Teeside University, Middlesbrough, UK.

Emmanuel Ogundimu (E)

Mathematical Sciences, University of Durham, Durham, UK.

Jason Trevis (J)

Department of Cardiothoracic Surgery, The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, MIddlesbrough, UK.

Janelle Wagnild (J)

Department of Anthropology, Durham University, Durham, UK.

Pasan Witharana (P)

Department of Cardiothoracic Surgery, The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, MIddlesbrough, UK.

Helen C Hancock (HC)

Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.

Rebecca H Maier (RH)

South Tees Academic Cardiovascular Unit, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.
Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.

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