Clinical trial NCT06818110: The CardioFit Trial: Exercise Training Before Aortic Valve Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Stenosis, Severe
Keywords: Exercise
Prehabilitation
Aortic valve replacement
Aortic stenosis
Cardiac surgery
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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)

Eligibility criteria: 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. EXCLUSION CRITERIA

* 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
* Currently participating in another interventional clinical trial (although this will be reviewed on a case-by-case basis)

Primary outcomes:
measure: Feasibility Outcomes
timeFrame: Baseline up to surgery
Secondary outcomes:
measure: Endurance time
timeFrame: Baseline up to surgery
measure: Change in objectively measured cardiopulmonary exercise testing variables
timeFrame: Baseline up to surgery
measure: Health-related quality of life
timeFrame: Baseline up to surgery
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hopsitals Southampton NHS FT
Study officials:
References: