Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design-a study protocol.

NGAAGE, Dumbor, MITCHELL, Natasha, DEAN, Alexandra, HIRST, Claire, AKOWUAH, Enoch, DOHERTY, Patrick Joseph, FAIRHURST, Caroline, FLEMMING, Kate, HEWITT, Catherine, HINDE, Sebastian, MITCHELL, Alex, NICHOLS, Simon and WATSON, Judith (2019). Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design-a study protocol. BMJ Open, 9 (12), e035787.

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Link to published version:: https://doi.org/10.1136/bmjopen-2019-035787


INTRODUCTION: Following cardiac surgery, patients currently attend an outpatient review 6 weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8 weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier. METHODS AND ANALYSES: This is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18-80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial. ETHICS AND DISSEMINATION: Ethics approval was granted by East Midlands-Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN80441309.

Item Type: Article
Uncontrolled Keywords: cardiothoracic surgery; health economics; rehabilitation medicine; statistics & research methods; 1103 Clinical Sciences; 1117 Public Health and Health Services; 1199 Other Medical and Health Sciences
Identification Number: https://doi.org/10.1136/bmjopen-2019-035787
Page Range: e035787
SWORD Depositor: Symplectic Elements
Depositing User: Symplectic Elements
Date Deposited: 07 Jan 2020 12:01
Last Modified: 18 Mar 2021 02:55
URI: https://shura.shu.ac.uk/id/eprint/25639

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