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

Completed · Not applicable

Conditions studied: Coronary Artery Bypass Graft, Non-cardiac Thoracic Surgery, Frailty

In brief

Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran population grows older and more frail, there is a critical need to identify effective strategies for reducing surgical risks for these patients. Prior research shows that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength and improving nutrition. The investigators believe that similar improvements may be obtained by using similar interventions before surgery to "prehabilitate" patients' capacity to tolerate the stress of surgery. The proposed research will examine the feasibility of a new, home-based prehabilitation intervention aimed at improving surgical outcomes after cardiothoracic surgery through preoperative exercise training and nutritional supplementation. Findings from the study will inform the design of a larger randomized controlled trial of the prehabilitation intervention. If proven effective, prehabilitation could benefit as many as 42,000 frail Veterans who are scheduled for major elective surgery each year.

Key facts

Study ID: NCT03299101
Run by: VA Office of Research and Development
People needed: 35
Starts: 2017-11-22
Expected to finish: 2020-09-30
Last updated by the study team: 2021-01-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Veteran patient scheduled for Coronary artery bypass graft (CABG), valve surgery, or other non-cardiac thoracic surgery;
Demonstrate at least mild frailty (e.g., Risk Analysis Index [RAI]>=16).
Physician/provider request for patients with RAI<16.

You may not qualify if…

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 (Left Ventricle) 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.

Where it is running

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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