Early initiation of cardiac rehabilitation following cardiac surgery with sternotomy Circulatory System
Conditions
Interventions
Current interventions as of 07/08/2025:
FARSTER-Care is a multi-centre, two-armed, randomised controlled trial (RCT) looking at the effects of early cardiac rehabilitation following cardiac surgery wi
Sponsors
Hull University Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 07/08/2025: 1. Aged =18 years 2. Undergoing elective or urgent cardiac surgery through a sternotomy 3. Capable of giving informed consent. 4. Patients capable of completing, and willing to complete, the ISWT. 5. Patients who are taking part in other research studies can still enter the trial as long as the first study does not include an intervention or element that may affect the FARSTER-care trial outcomes or would be overly burdensome for patients. Previous inclusion criteria: 1. Aged =18 years 2. Undergoing elective or urgent cardiac surgery through a sternotomy 3. Capable of giving informed consent. 4. Patients who are taking part in other research studies can still enter the trial as long as the first study does not include an intervention or element that may affect the FARSTER-care trial outcomes or would be overly burdensome for patients.
Exclusion criteria
Exclusion criteria: Patients with postoperative sternal wound complications like sternal instability, or postoperative complications requiring further specialised care, such as stroke rehabilitation and regular dialysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 07/08/2025: Aerobic fitness measured using the Incremental Shuttle Walk Test (ISWT) at the 6-month time point Previous primary outcome measures: 1. Aerobic fitness measured using the Incremental Shuttle Walk Test (ISWT) before CR commences (pre-CR timepoint), once CR finishes (post-CR timepoint) and at the 6-month timepoint 2. Physical health assessed via the following variables at Baseline, Outpatient review, Pre-CR, Post CR, and at the 6-month timepoint 2.1. Heart rate measured in beats per minute using a pulse oximeter 2.2. Blood pressure (systolic and diastolic) measured using standard trust procedure and recorded in mmHg 2.3. Oxygen saturation measured using a pulse oximeter 3. Perceived exertion (RPE) measured using the Borg Scale at Pre-CR, Post-CR, and at the 6-month timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Physical health assessed via the following variables at Baseline, Outpatient review, Pre-CR, Post CR, and at the 6-month timepoint 1.1. Heart rate measured in beats per minute using a pulse oximeter 1.2. Blood pressure (systolic and diastolic) measured using standard trust procedure and recorded in mmHg 1.3. Oxygen saturation measured using a pulse oximeter 2. Patient outcomes measured using a Patient Reported Outcome Measure - Cardiac Rehabilitation (PROM-CR) at Pre-CR, Post-CR, and at the 6-month timepoint 3. Psychological health measured using the Generalized Anxiety Disorder Scale (GAD-7) at Baseline, Pre-CR, Post-CR, and at the 6-month and 12-month timepoints 4. Quality of life measured using the EQ-5D-5L validated generic patient-reported outcome measure at Baseline, Pre-CR, Post-CR, and at the 6-month and 12-month timepoints 5. Patient-reported NHS and personal social services (PSS) resource use will be collected using a bespoke questionnaire at Pre-CR, and at the 6-month and 12-month timepoints 6. Complications measured using data collected in the documentation at baseline and 6 months, and throughout the trial in the form of adverse events. 7. Cardiac rehabilitation uptake measured using data recorded in the CR session logs by the end of the study measured using number of sessions attended between Pre-CR and Post-CR timepoints | — |
Countries
England, United Kingdom
Contacts
Public ContactNatasha;Jessica Mitchell;Goodliffe
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Outcome results
None listed