Cardiac surgery Surgery Cardiac surgery
Conditions
Interventions
Potentially eligible patients will be sequentially assigned a screening identification number irrespective of their participation in the trial and will be sent the participant information sheet (PIS)
Sponsors
South Tees Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients listed for elective cardiac surgery at the James Cook University Hospital 2. Age > = 18 years 3. Ability to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Unstable angina/ indication for urgent surgery 2. Malignant arrhythmias 3. Pregnancy 4. Currently participating in another interventional clinical trial 5. Contraindications to cardiac prehabilitation: 5.1 Acute systemic illness or fever 5.2 Uncontrolled atrial or ventricular arrhythmias 5.3 Uncontrolled sinus tachycardia (HR> 120 bpm) 5.3 Acute pericarditis or myocarditis 5.4 Uncompensated HF 5.5 Third degree (complete) atrioventricular (AV) block without pacemaker 5.6 Recent embolism 5.7 Severe Musculoskeletal conditions that would prohibit exercise 6. Contraindications to inspiratory muscle training: 6.1 History of spontaneous pneumothorax/ incomplete recovery following traumatic pneumothorax 6.2 Asthma patients who suffer from frequent, severe exacerbations 6.3 Recently perforated ear drum (within last 3 months) 6.4 Large lung Bullae
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in exercise capacity measured by the 6-minute walk test (6MWT) from baseline to post-prehabilitation intervention (at 4-weeks and prior to surgery) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Exercise capacity is measured using the 6-minute walk test at 6 and 12 weeks following the index surgery exercise capacity following surgery 2. Respiratory function is assessed using Maximal Inspiratory Pressure (MIP)at baseline, at the pre-surgical assessment, and at 6 and 12 weeks following the index surgery 3. Patient-reported quality of life is assessed using the EQ-5D-5L at baseline, at the pre-surgical assessment and at 6 and 12 weeks following the index surgery 4. Handgrip strength is assessed as a measure of frailty using a dynamometer at baseline, at the pre-surgical assessment and at 6 and 12 weeks following the index surgery 5. Anxiety and depression is assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline, at the pre-surgical assessment and at 6 and 12 weeks following the index surgery 6. Surgical and post-operative data (including duration of operation, cardiopulmonary bypass times, time on ICU and discharge information) will be collected from participants’ medical notes and recorded on Case Report Forms (CRF) during their stay in hospital 7. Post-operative cardiac and pulmonary complications and hospital stay data will be collected, during the inpatient stay and at the 6 and 12 week follow up following the index surgery 8. Case Report Forms (CRF’s) will capture data regarding the adherence and delivery of the intervention components from baseline to the day of surgery. Deviations from the proposed intervention components and timescales will be documented 9. Screening logs will be used to collect recruitment rate data including; the number of patients who meet the eligibility criteria, reasons for exclusion and for patients choosing not to participate in the study 10. CRF’s will be used to capture the completion of research activity and protocol adherence at each of the data collection | — |
Countries
England, United Kingdom
Contacts
Public ContactAyesha;Jennifer Mathias;Wilkinson
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Outcome results
None listed