Coronary Artery Disease Clinical Trial
— FARSTER-IOfficial title:
Feasibility Study of Early Outpatient Review and Early Cardiac Rehabilitation After Coronary Artery Bypass Grafting: Mixed Methods Research Design
Verified date | July 2020 |
Source | Hull University Teaching Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Current care after coronary artery bypass grafting (CABG) involves a check-up 6 weeks after
hospital discharge followed by an exercise programme called cardiac rehabilitation (CR) from
8 weeks. This practice is not evidence-based; it is therefore uncertain if earlier check-up
and CR would promote quicker recovery. The proposed research will examine the feasibility of
having check-up at 3 weeks and CR from 4 weeks after hospital discharge, and the associated
advantages.
The investigators plan to recruit 100 patients undergoing planned CABG through a median
sternotomy, at 2 NHS hospitals over 5 months. They will include 18 to 75 year olds, capable
of giving Informed consent and fit for CR exercises.
Patients will be approached before surgery and given study information to read. Four days
after surgery, patients who are willing to take part will have their routine clinical
examination, blood tests, chest x-rays and heart tracings reviewed to determine suitability
for the study. The investigators will obtain informed consent, do breathing tests and, ask
the patients to complete a general health questionnaire. A computer will allocate patients
equally to the proposed care (intervention group) or current care (control group). After
discharge, patients will attend check-up and semi-structured interview at 3 weeks
(intervention group) or 6 weeks (control group) before starting CR from 4 weeks (intervention
group) or 8 weeks (control group). CR will involve exercise classes once or twice a week for
8 weeks, and fitness tests. Patients will have a final assessment at 26 weeks, with clinical
examination, fitness and breathing tests, and completion of general health questionnaire.
The investigators will analyse patients' and staff experiences, patient fitness levels,
quality of life and costs, associated with each pathway. They will report potential benefits
of proposed care, if any. This study findings will be used to design a larger trial to
determine the best practice.
Status | Completed |
Enrollment | 29 |
Est. completion date | May 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Undergoing elective and urgent CABG - Having full median sternotomy - Capable of giving Informed consent. Exclusion Criteria: - Body Mass Index greater than 40kg/m2 - Heart failure with left ventricular ejection fraction of <30% - Early postoperative sternal wound complications such as infection and sternal instability - Postoperative complications resulting in prolonged hospital stay greater than 14 days after surgery. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Castle Hill Hospital | Kingston-Upon-Hull | East Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Hull University Teaching Hospitals NHS Trust | National Institute for Health Research, United Kingdom, South Tees Hospitals NHS Foundation Trust, University of York, York Trials Unit |
United Kingdom,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical fitness | Change in physical fitness assessed by incremental shuttle walk test | 6 months | |
Secondary | A standardized health questionnaire for measuring generic health status. | Quality of Life Questionnaire - Change in the quality of life measured using EQ-5D-5L, | 6 months | |
Secondary | Morbidity | Hospital readmission rates | 6 months | |
Secondary | Costs | Comparative costs of both care pathways | 6 months |
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