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SHAPE Test for Preoperative Risk Stratification
Sponsor: Yale University
Summary
Primary Objective Characterizing precise functional capacity in surgical patients is critical for risk stratification and identification of patients at high risk for perioperative complications. The primary objective for the study is to evaluate the feasibility of effective subject recruitment of an FDA-approved simplified cardiopulmonary exercise testing apparatus in adults \>60 years old prior to moderate to high-risk surgery. In addition, by development of a validation cohort of older adults, defined as \>60 years old, self-reporting \>4 METS and with a score of \<2 on the revised cardiac risk index (RCRI)1 we will compare its effectiveness when compared to conventional preoperative evaluation measures (METS determination by standard scoring and Duke Activity Status Index) to SHAPE™ testing.
Official title: A Feasibility Study of the SHAPE™ Test of Aerobic Fitness in Older Adults Presenting for Moderate to High-risk Surgery
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
OBSERVATIONAL
Enrollment
371
Start Date
2023-05-03
Completion Date
2026-05-29
Last Updated
2025-12-18
Healthy Volunteers
Yes
Interventions
Shape II
cardiopulmonary exercise testing apparatus
Locations (1)
Yale New Haven Hospital
New Haven, Connecticut, United States