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Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design-a study protocol
Open accessAbstract
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.
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Similar worries were articulated for steep reductions of 30-50% in European trials submitted for grants or ethical approval by the end of 2005.
“Similar worries were articulated for steep reductions of 30 50% in European trials submitted for grants or ethical approval by the end of 2005 351 353”
From European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions (2021) · cites this paper as [351]
The Methods and analysis sections discuss this cardiac-rehabilitation trial’s sample size and a 2019 ethics amendment, not European trial submissions by the end of 2005. Searches for the 30–50% reduction, European grant or ethics submissions, and 2005 found no passage addressing the claim. (LLM, conf=0.76)
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CONSORT 2010 statement: extension to randomised pilot and feasibility trials.
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European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions
Mentzelopoulos, S. D., Couper, K., Voorde, P. V. D., Druwé, P., Blom, M., Perkins, G. D., Lulic, I., Djakow, J., Raffay, V., Lilja, G., et al. (2021) · Resuscitation · doi:10.1016/j.resuscitation.2021.02.017 · Cited by 246
Metadata
- Authors
- 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., & Watson, J.
- Affiliations
- Castle Hill Hospital (GB)
- University of York (GB)
- James Cook University Hospital (GB)
- Sheffield Hallam University (GB)
- Corresponding author
- Ngaage, Dumbor
- ORCID
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2019-12
- Volume
- 9
- Issue
- 12
- Pages
- e035787
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC6937080
- OpenAlex
- W2996895717
- Cited by
- 6
- References
- 2
- Citations by year
- 2025: 1 · 2023: 2 · 2021: 3
- FWCI
- 0.54
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- BMJ Open (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- SHURA (Sheffield Hallam University Research Archive) (Sheffield Hallam University) (acceptedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (acceptedVersion)
- HighWire Press Open Archive (acceptedVersion)
- Edinburgh Napier Research Repository (Edinburgh Napier University) (acceptedVersion, cc-by)
- SHURA (Sheffield Hallam University Research Archive) (Sheffield Hallam University) (submittedVersion)
- Open Access Institutional Repository at Robert Gordon University (Robert Gordon University) (submittedVersion, cc-by)
- Funders
- National Institute for Health Research (PB-PG-0317-20047)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
- Health Sciences › Medicine › Surgery › Cardiac and Coronary Surgery Techniques
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Medical Practices and Rehabilitation
- Keywords
- cardiac rehabilitation, cardiac surgery, median sternotomy, postoperative recovery, physical activity limitation, feasibility, trial acceptability, patient recruitment and retention, postoperative care
- MeSH terms
- Cardiac Rehabilitation, Aftercare, Ambulatory Care, Feasibility Studies, Cardiac Surgical Procedures, Humans, Time Factors, Randomized Controlled Trials as Topic
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