The CardioFit Trial: Exercise Training Before Aortic Valve Surgery

University Hospital Southampton NHS Foundation Trust

Status: Active, not recruiting

Conditions: Aortic Stenosis, Severe

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06818110

RHM CAR0655

Details and patient eligibility

About

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.

Full 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)

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

An in-hospital Structured Responsive Exercise-Training Programme (SRETP)

Other group

Description:

Participants will participate in a structured, responsive, exercise training programme (SRETP) on a cycle ergometer. This training programme has been used in numerous international clinical trials, in several patient cohorts including cancer and lung disease. The training programme will involve short periods of exercise at a high intensity interspersed with short periods of exercise at a moderate intensity. This mode of exercise training is termed aerobic high-intensity interval training (HIIT). Exercise intensities during the interval exercise training program are specific to each participant and will be derived from the CPET. Moderate-intensity exercise is recognised as exercise below the anaerobic threshold. Participants will exercise at 80% of the work rate achieved at the anaerobic threshold (80%AT) for moderate-intensity exercise. High-intensity exercise is recognised as 50% of the difference between the "V" ̇O2 at the anaerobic threshold and the "V" ̇O2 peak (50%∆).

Treatment:

Other: Exercise