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

Authors

Dumbor Ngaage

Natasha Mitchell

Alexandra Dean

Claire Hirst

Enoch Akowuah

Patrick Joseph Doherty

Caroline Fairhurst

Kate Flemming

Catherine Hewitt

Sebastian Hinde

Alex Mitchell

Simon Nichols

Judith Watson



Abstract

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. 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 approval was granted by East Midlands—Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences, and disseminated via peer-reviewed research publications and to relevant stakeholders. This trial has been registered with reference ISRCTN80441309.

Citation

NGAAGE, D., MITCHELL, N., DEAN, A., HIRST, C., AKOWUAH, E., DOHERTY, P.J., FAIRHURST, C., FLEMMING, K., HEWITT, C., HINDE, S., MITCHELL, A., NICHOLS, S. and WATSON, J. 2019. Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design: a study protocol. [Protocol]. BMJ open [online], 9(12), article number e035787. Available from: https://doi.org/10.1136/bmjopen-2019-035787

Other Type Protocol
Acceptance Date Dec 2, 2019
Online Publication Date Dec 29, 2019
Publication Date Dec 31, 2019
Deposit Date Nov 29, 2023
Publicly Available Date Nov 29, 2023
Publisher BMJ Publishing Group
DOI https://doi.org/10.1136/bmjopen-2019-035787
Keywords Cardiac patients; Cardiac outpatients; Cardiac rehabilitation; Outpatient review
Public URL https://rgu-repository.worktribe.com/output/2079506

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