Aortic Stenosis, Severe
Conditions
Keywords
Exercise, Prehabilitation, Aortic valve replacement, Aortic stenosis, Cardiac surgery
Brief summary
The CardioFit Trial: The feasibility, safety and tolerability of an exercise training programme in patients with severe aortic stenosis prior to aortic valve replacement surgery: A feasibility trial To investigate if a Structured Responsive Exercise Training Programme (SRETP) delivered before aortic valve replacement (AVR) in patients with severe aortic stenosis is feasible, safe, and tolerable. Fitter patients have better surgical outcomes. Exercising post AVR surgery has been well documented and supported through cardiac rehabilitation programmes. However, there is limited evidence investigating exercising patients preoperatively, in part related to safety considerations in patients with severe aortic stenosis. If undertaking a SRETP before AVR in patients with severe aortic stenosis is shown to be feasible and safe, it provides a prehabilitation opportunity to enhance physical fitness with the aim of improving surgical outcomes. Therefore, this trial will investigate whether SRETP (Prehabilitation) delivered before AVR in patients with severe aortic stenosis is safe & feasible.
Detailed description
Single-centre Feasibility trial 15 patients * Age ≥ 18 years old * Severe aortic stenosis with a multidisciplinary team (MDT) plan for elective, aortic valve replacement * At least 14 days until planned to come in (TCI) date * Diagnosis of critical aortic stenosis defined as a mean gradient of ≥60mmHg or Vmax ≥5 m/s * Presyncope/syncope due to aortic stenosis * Unstable angina/indication for urgent surgery * Malignant arrhythmias * Known pregnancy * Patients declining surgery * Patients weight exceeds 160kg * Patients unable to give informed consent Intervention: 1) An in-hospital Structured Responsive Exercise-Training Programme (SRETP). The intervention will be delivered before surgery. Feasibility Outcomes: 1. Adherence to the intervention of ≥75% 2. Tolerability of the intervention (minutes completed during the interval training) of ≥75% 3. Adverse Events to SRETP * Currently participating in another interventional clinical trial (this will be reviewed on a case-by-case basis) Contraindications to SRETP: * Acute systemic illness or fever * Uncontrolled atrial or ventricular arrhythmias * Uncontrolled sinus tachycardia (heart rate \>120bpm) * Acute pericarditis or myocarditis * Decompensated heart failure * Second or Third degree (complete) atrioventricular block without pacemaker * Recent pulmonary embolism or deep vein thrombosis within 2 weeks * Patients are unable to perform CPET (e.g. severe musculoskeletal conditions)
Interventions
OTHERExercise
The supervised exercise-training sessions will last \<1 hour, and exercise-training intensities will be individually tailored to each participant using the results from their CPET. Participants will be screened prior to each session to ensure that it is safe to perform exercise. Exercise training will involve repeated exercise bouts of 3 minutes at a moderate exercise intensity (80%AT) followed by 2 minutes of exercise at a high-intensity (50%∆) for a predetermined amount of time. Five minutes of freewheel cycling will be performed at the start and end of the protocol for a warm-up and cool-down. Exercise sessions can be terminated by the participant at any time. Participants will have continuous ECG and SpO2 monitoring throughout the training session. Vital signs will be taken before (some during) and after each training session.
Sponsors
University Hospital Southampton NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
4.1. INCLUSION CRITERIA Participants may enter the study if ALL of the following apply: * Age ≥ 18 years old * Severe aortic stenosis with a multidisciplinary team (MDT) plan for elective, aortic valve replacement * At least 14 days until planned to come in (TCI) date.
Exclusion criteria
4.2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Outcomes | Baseline up to surgery | 1. Adherence to the intervention ≥75% 2. Tolerability of the intervention (minutes completed during the interval training) of ≥75% 3. Adverse Events to the intervention (defined as occurring during or up to 30-minutes post exercise training) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endurance time | Baseline up to surgery | Change in time to limit of tolerance (endurance time) as measured by a constant work-rate exercise test |
| Change in objectively measured cardiopulmonary exercise testing variables | Baseline up to surgery | Measure a change in cardiopulmonary exercise variables. These include but are not limited to: Oxygen uptake (VO2) at anaerobic threshold (AT) Oxygen uptake at peak exercise VE/VCO2 slope Oxygen pulse |
| Health-related quality of life | Baseline up to surgery | Changes in health related quality of life measurements using validated questionnaires including: EQ-5D-5L: A standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ-Q): A validated, brief, self-administered tool to measure changes in quality of life in patients with aortic stenosis undergoing an intervention. |
Countries
United Kingdom
Outcome results
None listed