Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT05834556
Eligibility Criteria:
Inclusion Criteria:
1. Adults (≥ 18 years of age) undergoing elective isolated coronary artery bypass graft (CABG), aortic valve repair or replacement for moderate aortic stenosis or severe regurgitation, mitral valve repair or replacement for moderate stenosis or severe regurgitation or combined CABG/valve procedures.
2. Patients with a Clinical Frailty Score (CFS) between 3 (managing well) and 6 (living with moderate frailty) as determined by the Cardiac Surgeons or the Nurse Practitioner and/or a score of less than/= 60 on the Short Form 36 Physical Function (SF-36 PF).
3. Patients with an estimated wait time of 3 weeks or longer.
4. Have access to the internet and hardware (smartphone, tablet, computer) to support video telerehabilitation.
5. Have a support person (family member, friend, or caregiver) who is available for all exercise sessions (virtual and independent home exercises). This person should be able to provide technical assistance if needed (help navigate a device to join the telerehabilitation session, set up the device to best view the patient while exercising), is physically capable to stand beside the patient and provide physical assistance if the patient were to lose their balance and is able to respond to any unexpected emergency while the patient is exercising (i.e. provide assistance and/or call 911 if needed).
Exclusion Criteria:
1. Patients who have unstable or recent unstable cardiac syndrome as defined by:
1. Severe heart failure (NYHA IV) or angina (CCS class IV) symptoms.
2. Critical left main (LM) coronary disease (\>50% stenosis).
3. Hospitalization for arrhythmias, congestive heart failure (CHF), or acute coronary syndrome (ACS).
2. Patients who have severe left ventricular obstructive disease as defined by:
a. Severe aortic or mitral stenosis (aortic or mitral valve area \<1.0 cm2 or mean gradient \> 40 mmHg or \> 10 mmHg respectively); or dynamic left ventricular outflow obstruction.
3. Patients who have demonstrated exercise induced ventricular arrhythmias or have experienced a recent hospitalization for arrhythmias.
4. Patients who have cognitive deficits that would preclude prehabilitation.
5. Patients who have physical limitations that would preclude their ability to complete the pre-defined exercises in the intervention.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05834556
Study Brief:
Protocol Section:
NCT05834556