Pilot Testing a Home-Based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery

Background: Frail Veterans are at increased risk for poor surgical outcomes. Although
surgical techniques have advanced to a level where surgery on very old adults is feasible, if
a patient is also frail, the stress of surgery may overwhelm their adaptive capacities,
placing them at increased risk of mortality, morbidity, and institutionalization even if
surgery is technically successful. Frailty is a clinical syndrome that is commonly
characterized by muscle atrophy, diminished strength and speed, decreased physical activity,
and exhaustion. It is independent of any specific disease, but it increases with age and
worsens disease prognoses by diminishing capacity to tolerate stressors. Thus, while surgery
is often indicated for older patients, frail candidates are less likely than robust
counterparts to tolerate the procedure and/or recover functional capacity. In fact, recent VA
data demonstrate that frailty is a more powerful predictor of increased perioperative
mortality, morbidity, length of stay, and cost than predictions based on age or comorbidity
alone. As the Veteran and US populations grow older, frailty will increase, making it
critically important to identify effective strategies for improving the surgical recovery and
outcomes of frail patients.

"Prehabilitation" has the potential to improve surgical outcomes among the frail. Prior
research demonstrates that inter-disciplinary rehabilitation strategies deployed after
surgery enhance recovery and improve outcomes by building strength and improving nutrition.
Based on this success, there is growing interest in "prehabilitation", which is a similar
intervention deployed before surgery. By modifying physiological and environmental risks,
prehabilitation aims to augment patients' capacity to compensate for the stress of surgery
itself and the convalescent period thereafter. Frail patients may benefit disproportionately
from prehabilitation because they have diminished capacity to endure the procedure and/or
recovery. Preliminary evidence suggests that preoperative exercise interventions improve
surgical outcomes. However, prehabilitation has not yet been studied in either Veteran or
specifically frail populations, and no prior studies used home-based prehabilitation
strategies to safely minimize travel-related barriers to participation.

Objectives: The investigators will examine the feasibility of a novel, multifaceted,
home-based prehabilitation intervention designed to improve functional capacity and
postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Specific aims
are to:

1. Estimate rates of recruitment, retention, and adherence to the intervention; and
evaluate participation barriers.

2. Measure changes over time in frailty, physical function, pulmonary function, nutrition,
and health-related quality of life at baseline, the day of surgery, and 30 and 90 days
after surgery.

3. Explore changes in postoperative mortality, major complications, length of hospital
stay, and level of independent living using case-matched historical controls.

Methods: This single-arm pilot study will enroll a consecutive cohort of up to 30 Veterans
identified as frail using a standardized frailty assessment and scheduled for major
cardiothoracic surgery at the VA Pittsburgh Healthcare System. The 4 week long
prehabilitation regimen will include: (a) aerobic conditioning, (b) strength and coordination
training, (c) respiratory muscle training, and (d) nutritional coaching and supplementation.
Pre- and post-prehabilitation assessments will include: (a) frailty; (b) physical function;
(c) pulmonary function; (d) nutrition; and (e) health-related quality of life. Postoperative
outcomes will include length of stay, mortality and complications. Compliance with the
prehabilitation regimen will be assessed through patient logs and pedometers. Analyses will
inform a larger randomized controlled trial testing the prehabilitation intervention.
Findings will be relevant for the 42,000 frail Veterans scheduled for major elective surgery
each year.

Inclusion Criteria:

1. Veteran patient scheduled for CABG, valve surgery, or other non-cardiac thoracic
surgery;

2. Demonstrate at least mild frailty (e.g., RAI>=16).

3. Physician/provider request for patients with RAI<16.

Exclusion Criteria:

- Emergent, urgent, or otherwise time-sensitive surgery that precludes prehabilitation;

- Unstable or recent unstable cardiac syndrome as defined by (a) acute coronary syndrome
within 6 weeks; (b) decompensated heart failure; (c) New York Heart Association Class
IV Heart Failure; (d) unstable angina; (e) Canadian Cardiovascular Society Class IV
symptoms; (f) critical left main coronary disease; (g) clinically significant
arrhythmias,

- Severe valvular heart disease: (a) severe aortic or mitral stenosis (aortic or mitral
valve area <1.0 cm2 or mean gradient >40 or >10 mm Hg, respectively)

- Dynamic LV outflow obstruction

- Physical, cognitive, social or logistical limitations preventing participation in the
prehabilitation regimen, including:

- Patients who require surrogate consent for the planned surgery

- Patients with court orders of incompetence or clinical determinations of incapacity
documented in the medical record

- Clinical exam by study physician consistent with incapacity

- Patients who at any time during prehabilitation or longitudinal follow up demonstrate
insufficient cognitive capacity to safely and effectively carry out the prescribed
activities.

- Unable to speak English.

- Surgery is cancelled by IMPACT clinic or surgeon due to unacceptable risk.