Feasibility Study of Early Review and Early Cardiac Rehabilitation After Coronary Artery Bypass
NCT03551015 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2020-07-16
Summary
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.
Conditions
- Coronary Artery Disease
- Quality of Life
Interventions
- OTHER
-
Change in the timing of components of usual care
Bringing forward outpatient review, and cardiac rehabilitation after CABG by 3 and 4 weeks respectively.
Sponsors & Collaborators
-
South Tees Hospitals NHS Foundation Trust
collaborator OTHER -
University of York
collaborator OTHER -
York Trials Unit
collaborator UNKNOWN -
National Institute for Health Research, United Kingdom
collaborator OTHER_GOV -
Hull University Teaching Hospitals NHS Trust
lead OTHER_GOV
Principal Investigators
-
Dumbor Ngaage · Hull University Teaching Hospitals NHS Trust
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-05
- Primary Completion
- 2020-01-31
- Completion
- 2020-05-31
Countries
- United Kingdom
Study Locations
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