NCT06818110

The CardioFit Trial: Exercise Training Before Aortic Valve Surgery

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University Hospital Southampton NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Aortic Stenosis, Severe

Interventions

Type	Name	Description
OTHER	Exercise	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.

Timeline

• Start date: 2025-01-28
• Primary completion: 2025-10-10
• Completion: 2025-12-10
• First posted: 2025-02-10
• Last updated: 2025-02-10

Locations

1 site across 1 country: United Kingdom