The CardioFit Trial: Exercise Training Before Aortic Valve Surgery

NCT ID: NCT06818110

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-28
• Study Completion Date: 2025-12-10

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)

Conditions

Aortic Stenosis, Severe

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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%∆).

Group Type: OTHER

Exercise

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

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

Eligibility Criteria

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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hopsitals Southampton NHS FT

Southampton, , United Kingdom

Countries

United Kingdom

Other Identifiers

RHM CAR0655

Identifier Type: -

Identifier Source: org_study_id