SHAPE Test for Preoperative Risk Stratification (SHAPEPAT)

April 30, 2026 updated by: Zyad Carr, Yale University

A Feasibility Study of the SHAPE™ Test of Aerobic Fitness in Older Adults Presenting for Moderate to High-risk Surgery

This study is looking at whether a simplified exercise test called the SHAPE-HF cardiopulmonary testing system can be used before surgery in older adults. Doctors often need to know how well a patient's heart, lungs, and body handle physical activity before moderate- to high-risk surgery. This information may help them better understand a patient's fitness for surgery and possible risk of complications afterward.

The study will enroll adults older than 60 years who are being evaluated before planned moderate- to high-risk noncardiac surgery. The first goal is to determine if this was feasible in older adults and to learn whether patients can be successfully recruited to complete this pre-surgery test. Secondly, the study will also look at how results from the SHAPE-HF system compare with common ways doctors now estimate fitness, such as asking patients about their physical activity and using a standard questionnaire.

Participants will attend one in-person study visit lasting about 35 minutes. During that visit, they will answer questions about their activity level and complete testing with the SHAPE-HF system. The test uses short periods of lower-intensity exercise to estimate aerobic fitness. After the visit, participants will be contacted by phone about 24 hours later to check for any problems related to the study test.

Lastly, researchers will also review information from the medical record for 30 days after surgery to see whether test results are related to recovery, short-term health problems after surgery, or major complications. No extra surgery or change in planned medical care is part of this study. The information learned may help improve how doctors evaluate older adults before surgery in the future.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Preoperative functional capacity is a central component of perioperative risk assessment in older adults undergoing moderate- to high-risk surgery. Reduced cardiopulmonary reserve is associated with increased postoperative morbidity, prolonged recovery, and major adverse cardiovascular events, yet functional capacity in routine practice is often estimated using subjective measures such as self-reported activity tolerance, MET estimates, and questionnaire-based assessment. These tools are practical but may misclassify physiologic fitness, particularly in older adults who report acceptable activity levels despite diminished aerobic reserve.

Objective cardiopulmonary exercise testing can provide more precise assessment, but widespread use is limited by the complexity and burden of conventional testing. The SHAPE-HF cardiopulmonary testing system is an FDA-approved simplified submaximal exercise testing platform intended to provide objective assessment of aerobic fitness in a manner that may be more feasible for routine use in a preoperative clinic.

Conventional cardiopulmonary exercise testing can provide objective assessment of aerobic capacity, but broad implementation is often limited by time, workflow, equipment, and patient burden. The SHAPE-HF cardiopulmonary testing system is an FDA-approved simplified submaximal cardiopulmonary exercise testing platform designed to generate objective physiologic measures of aerobic fitness using abbreviated exercise testing. This approach may offer a more practical method for assessing functional capacity in a high-volume preoperative clinic while reducing the burden associated with traditional maximal exercise testing.

This study is a prospective, single-site, non-randomized investigation evaluating the use of the SHAPE-HF cardiopulmonary testing system in adults older than 60 years who are undergoing preoperative evaluation before moderate- to high-risk surgery. The study population includes patients with a Revised Cardiac Risk Index (RCRI) score less than 4 and self-reported functional capacity greater than 4 METs who otherwise meet protocol-defined eligibility criteria. This population was selected because many such patients would typically be considered to have acceptable functional status by standard preoperative screening, yet some may still have unrecognized limitations in aerobic capacity and increased perioperative risk.

The study has been modified over time to support progressively broader scientific aims. It was initially conducted as a technical proof-of-concept study enrolling 42 participants to evaluate implementation of simplified submaximal cardiopulmonary exercise testing in the preoperative setting. The protocol was subsequently modified to a feasibility study with a planned enrollment of 101 participants to evaluate recruitment, workflow integration, and practical use of the SHAPE-HF system in an older surgical population. The study has now been further expanded to a total planned enrollment of 371 participants in order to better evaluate perioperative complications and the relationship between submaximal cardiopulmonary exercise testing performance and postoperative outcomes, and to provide adequate statistical power to identify associations with major adverse perioperative events.

Participants complete a single in-person study visit of approximately 35 minutes during the preoperative period. During this visit, conventional preoperative functional assessments are obtained, including subjective MET assessment and Duke Activity Status Index evaluation, and participants undergo SHAPE-HF submaximal cardiopulmonary exercise testing. A follow-up telephone contact is performed approximately 24 hours after testing to assess for adverse events related to the study procedure. Participants then undergo postoperative follow-up through medical record review for 30 days after surgery.

The primary objectives of the current study are to evaluate the feasibility and operational performance of using the SHAPE-HF cardiopulmonary testing system in a preoperative clinic for older adults undergoing moderate- to high-risk surgery and to assess the relationship between SHAPE-HF-derived performance measures and clinically relevant postoperative outcomes. Study aims include comparison of SHAPE-HF results with conventional measures of functional capacity, including subjective MET assessment and Duke Activity Status Index scores. The study also evaluates whether SHAPE-HF performance variables are associated with short-term postoperative morbidity, as measured by the Postoperative Morbidity Survey, and with major postoperative complications within 30 days of surgery.

Postoperative outcomes of interest include major adverse cardiovascular and other clinically significant perioperative events, including myocardial infarction, stroke, atrial fibrillation, congestive heart failure, pneumonia, hospital readmission, and death. By expanding from proof-of-concept and feasibility phases to a larger powered cohort, the study is intended to determine whether abbreviated submaximal cardiopulmonary exercise testing can improve identification of older surgical patients at elevated perioperative risk beyond conventional subjective assessment alone.

This investigation is not designed to alter the participant's planned surgical treatment or routine perioperative care. Rather, it evaluates whether an abbreviated, objective, and scalable assessment of aerobic fitness can be integrated into preoperative evaluation and whether the resulting physiologic measures may improve perioperative risk stratification in older adults presenting for moderate- to high-risk surgery.

Study Type

Observational

Enrollment (Estimated)

371

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The overall goal is the 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

Description

Inclusion Criteria:

  • Aged >60 years
  • Scheduled for pre-surgical evaluation for moderate to high-risk surgical procedure.
  • RCRI <2 based on screening of preoperative co-morbidities.
  • Provision of signed and dated informed consent form

Exclusion Criteria:

  1. Age <60 years old
  2. Subjective METS <4
  3. Inability to give independent informed consent
  4. Revised Cardiac Risk Index (RCRI) >2
  5. Neurological impairment with motor limitations
  6. Mental impairment leading to inability to cooperate
  7. Recent NSTEMI or STEMI type myocardial infarction (within 6 months)
  8. Angina (stable or unstable, within 6 months)
  9. Uncorrected severe valvular heart disease (severe aortic, tricuspid, or mitral stenosis)
  10. Recent exacerbation of congestive heart failure (requiring hospitalization, within 6 months)
  11. Acute pulmonary embolism or deep vein thrombosis (within past 6 months)
  12. Uncontrolled pulmonary edema
  13. Uncontrolled symptomatic arrhythmias
  14. Active endocarditis
  15. Acute myocarditis or pericarditis
  16. Active wheezing or home oxygen use
  17. Recent exacerbation of chronic obstructive pulmonary disease or asthma or pneumonia (requiring hospitalization, within 6 months)
  18. Inability to perform components of the SHAPE test (severe hip flexion limitation, severe osteoarthritis of knee or hip, limb immobilization, ambulation with a walker, can or crutches, baseline balance irregularities
  19. Diagnosis of vertigo
  20. Known allergic reactions to components of the SHAPE medical system apparatus disposable mouthpiece.
  21. Active enrollment in an interventional clinical trial within the enrollment period of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Validation Cohort
Older subjects (>60 years old) presenting for moderate to high-risk surgical procedure with reported subjective metabolic equivalents of >4 METS and with a score of <4 on the revised cardiac risk index (RCRI) undergoing submaximal exercise testing.
Device: Shape II
cardiopulmonary exercise testing apparatus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Success
Time Frame: 0-30 days

The primary objective for the study is a study enrollment rate of 25% of eligible candidates.

Within the parameters of a feasibility study, the following questions will also be addressed:

  • Physical capacity of clinic to handle the number of participants in the study.
  • Adequate communication and time frame to efficiently perform abbreviated cardiopulmonary exercise testing in high-volume preoperative testing environment.
  • Adequate software and hardware to capture and use data obtained from abbreviated cardiopulmonary exercise testing.
  • Determination of adequate institutional, departmental and clinical support to maintain and perform abbreviated cardiopulmonary exercise testing as an adjunct for preoperative testing.
  • Does abbreviated cardiopulmonary testing in a preoperative testing environment improve access to care in a diverse and at-risk surgical population
0-30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conventional measure of metabolic equivalents (METS)
Time Frame: 0-1 day
If conventional measures of METS (subjective METS, Duke Activity Status Index) compare favorably to the SHAPE testing performance variables.
0-1 day
Perioperative Morbidity Survey
Time Frame: 0-30 days
• If SHAPE™ performance variables predict a higher risk of postoperative morbidity after surgery using the Postoperative Operative Morbidity Survey (POMS), a short-term measure of postoperative morbidity after major elective surgery.
0-30 days
Major postoperative outcomes
Time Frame: 0-30 days
• If SHAPE™ performance variables predict a higher risk of postoperative major morbidity as measured by traditional major 30-day complications (myocardial infarction, stroke, atrial fibrillation, surgical site infection, postoperative pulmonary complications)
0-30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Zyad J Carr, M.D., Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2023

Primary Completion (Estimated)

May 29, 2026

Study Completion (Estimated)

May 29, 2026

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000033885

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Variable description, values and deidentified patient physiological data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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