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

NCT03299101 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-01-13

Study results available
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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 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.

Conditions

  • Coronary Artery Bypass Graft
  • Non-cardiac Thoracic Surgery
  • Frailty

Interventions

OTHER

Prehabilitation

Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Daniel E. Hall, MD MDiv MHSc · VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-22
Primary Completion
2020-04-30
Completion
2020-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03299101 on ClinicalTrials.gov