Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06818110

The CardioFit Trial: Exercise Training Before Aortic Valve Surgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aortic Stenosis, Severe Aortic Valve Disease Aortic Valve Stenosis Behavior Cardiovascular Diseases Heart Diseases Heart Valve Diseases Motor Activity Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hopsitals Southampton NHS FT

Southampton, SO16 6YD, United Kingdom

About this study

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:

  • Adherence to the intervention of ≥75%
  • Tolerability of the intervention (minutes completed during the interval training) of ≥75%
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

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.

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

Primary outcomes

  1. Feasibility Outcomes

    Time frame: Baseline up to surgery

    • Adherence to the intervention ≥75%
    • Tolerability of the intervention (minutes completed during the interval training) of ≥75%
    • Adverse Events to the intervention (defined as occurring during or up to 30-minutes post exercise training)

Secondary outcomes

  1. Endurance time

    Time frame: Baseline up to surgery

    Change in time to limit of tolerance (endurance time) as measured by a constant work-rate exercise test

  2. Change in objectively measured cardiopulmonary exercise testing variables

    Time frame: 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

  3. Health-related quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Registry information

Official study 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

Acronym: CardioFit

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.