The CardioFit Trial: Exercise Training Before Aortic Valve Surgery

NCT06818110 | Active Not Recruiting

• 1 other identifier: RHM CAR0655
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis, Severe

Keywords

Exercise; Prehabilitation; Aortic valve replacement; Aortic stenosis; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Feasibility Outcomes

  1. Adherence to the intervention ≥75% 2. Tolerability of the intervention (minutes completed during the interval training) of ≥75% 3. Adverse Events to the intervention (defined as occurring during or up to 30-minutes post exercise training)

  Baseline up to surgery

Secondary Outcomes (3)

• Endurance time

  Baseline up to surgery

• Change in objectively measured cardiopulmonary exercise testing variables

  Baseline up to surgery

• Health-related quality of life

  Baseline up to surgery

Study Arms (1)

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

OTHER

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%∆).

Other: Exercise

Interventions

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.

Also known as: An in-hospital Structured Responsive Exercise-Training Programme (SRETP)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

University Hopsitals Southampton NHS FT

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: February 10, 2025
• Study Start: January 28, 2025
• Primary Completion: October 10, 2025
• Study Completion: December 10, 2025
• Last Updated: February 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: "Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis."
• Access Criteria: Completion of trial

Locations

GB (1)