NCT05743673 SHAPE Test for Preoperative Risk Stratification

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 371 participants in total. It began in 2023-05-03 with a primary completion date of 2026-05-29.

Brief Summary

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.

Eligibility Criteria

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.

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