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RECRUITING
NCT05743673

SHAPE Test for Preoperative Risk Stratification

Sponsor: Yale University

View on ClinicalTrials.gov

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

DEVICE

Shape II

cardiopulmonary exercise testing apparatus

Locations (1)

Yale New Haven Hospital

New Haven, Connecticut, United States