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The CardioFit Trial: Exercise Training Before Aortic Valve Surgery

NCT06818110 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-02-10

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis, Severe

Interventions

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.

Sponsors & Collaborators

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-28
Primary Completion
2025-10-10
Completion
2025-12-10

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06818110 on ClinicalTrials.gov