Home-based exercise program for frail individuals awaiting cardiac surgery

Home-based Prehabilitation for Frail Cardiac Surgery Patients (HOME FREE) - A Quasi-experimental Feasibility Study

This study tests a home-based exercise program for frail adults getting ready for heart surgery to see if they like it and can stick with it.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: St. Boniface Hospital (other)
• Locations: 1 site (Winnipeg, Manitoba)
• Trial ID: NCT05834556 on ClinicalTrials.gov

What this trial studies

This feasibility study evaluates a home-based exercise program supported by a physiotherapist for frail adults preparing for cardiac surgery. It aims to assess patient interest in virtual participation, adherence to the exercise regimen, and the practicality of the program's components, including exercise guidance and virtual sessions. The study will recruit participants from St. Boniface Hospital in Winnipeg, Manitoba, and will focus on understanding the physical activity behaviors of these patients. The primary goal is to determine the feasibility and safety of this prehabilitation intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate frailty awaiting elective cardiac surgery.

Not a fit: Patients who do not have access to the internet or necessary hardware for virtual sessions may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could enhance the physical readiness of frail patients before cardiac surgery, potentially improving surgical outcomes.

How similar studies have performed: Other studies have shown promising results with home-based prehabilitation programs for surgical patients, indicating potential success for this approach.

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.

Where this trial is running

Winnipeg, Manitoba

• St Boniface Hospital — Winnipeg, Manitoba, Canada (RECRUITING)

Study contacts

• Principal investigator: Kelly Codispodi, BMR PT — University of Manitoba
• Study coordinator: Rakesh Arora, MD

Conditions: Frailty, Pre-operative Exercise, Prehabilitation, Cardiac Surgery, Telerehabilitation, telerehabilitation, prehabilitation, cardiac surgery