Status:
COMPLETED
Pilot Testing a Home-Based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery
Lead Sponsor:
VA Office of Research and Development
Conditions:
Coronary Artery Bypass Graft
Non-cardiac Thoracic Surgery
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 surgic...
Detailed Description
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 fr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03299101
Start Date
November 22 2017
End Date
September 30 2020
Last Update
January 13 2021
Active Locations (1)
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1
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240