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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03551015 on ClinicalTrials.gov