Early postoperative review and cardiac rehabilitation

Category Primary study
Registry of TrialsISRCTN registry
Year 2024
INTERVENTION: FARSTER‐Care is a multi‐centre, 2‐armed, randomised control trial (RCT) looking at the effects of early cardiac rehabilitation following cardiac surgery with sternotomy compared with the standard treatment. Eligible and consenting patients be asked to complete a questionnaire (supported by the R&D team at the participating site) and have their blood pressure, weight, height, and waist circumference measured. Participants will then be randomised on a 1:1 basis to either the FARSTER‐Care group (n = 294) or the usual care group (n = 294) using block randomisation stratified by site. The allocation schedule will be generated by a trial statistician not otherwise involved in the recruitment or randomisation of patients, and implemented via a central, web‐based randomisation system designed and managed by the YTU. Sites will be provided access to the randomisation system which will automatically send the research team at the site and the trial team at YTU the treatment allocation. Those in the FARSTER‐Care group will receive their specialist outpatient appointment three weeks following hospital discharge followed by commencement of CR from four weeks. The standard care group will have their specialist outpatient appointment si Xweeks after hospital discharge followed by commencement of CR from eight weeks. Both groups will be offered CR for eight weeks and can be completed in person, remotely, or a hybrid of both. At the first CR session, participants will be provided with advice and leaflets on cardiac risk factor reduction. They will also undergo an assessment by a physiotherapist which will involve exercise testing using the Incremental Shuttle Walk Test (ISWT) which measures aerobic fitness. Participants will also be given a pre‐rehabilitation questionnaire to complet CONDITION: Early initiation of cardiac rehabilitation following cardiac surgery with sternotomy ; Circulatory System PRIMARY OUTCOME: 1. Aerobic fitness measured using the Incremental Shuttle Walk Test (ISWT) before CR commences (pre‐CR time point), once CR finishes (post‐CR time point) and at the six‐month time point; 2. Physical health assessed via the following variables at Baseline, Outpatient review, Pre‐CR, Post CR, and at the six‐month time point; 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 six‐month time point 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. SECONDARY OUTCOME: 1. Physical health assessed via the following variables at Baseline, Outpatient review, Pre‐CR, Post CR, and at the six‐month time point; 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 [timepoint]: Pre‐CR, Post‐CR, and at the six‐month time point; 3. Psychological health measured using the Generalized Anxiety Disorder Scale (GAD‐7) at Baseline, Pre‐CR, Post‐CR, and at the six‐month and twelve‐month time points; 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 six‐month and twelve‐month time points; 5. Patient‐reported NHS and personal social services (PSS) resource use will be collected using a bespoke questionnaire at Pre‐CR, and at the six‐month and twelve‐month time points; 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] at measured using number of sessions attended between Pre‐CR and Post‐CR timepoints
Epistemonikos ID: db4dd7ea3efdf7745a23b10d8175b74928a5ba87
First added on: Aug 28, 2024