RECRUITING

SHAPE Test for Preoperative Risk Stratification

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-05-03
Study Completion:2026-05-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05743673

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.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged \>60 years
  2. * Scheduled for pre-surgical evaluation for moderate to high-risk surgical procedure.
  3. * RCRI \<2 based on screening of preoperative co-morbidities.
  4. * Provision of signed and dated informed consent form
  1. 1. Age \<60 years old
  2. 2. Subjective METS \<4
  3. 3. Inability to give independent informed consent
  4. 4. Revised Cardiac Risk Index (RCRI) \>2
  5. 5. Neurological impairment with motor limitations
  6. 6. Mental impairment leading to inability to cooperate
  7. 7. Recent NSTEMI or STEMI type myocardial infarction (within 6 months)
  8. 8. Angina (stable or unstable, within 6 months)
  9. 9. Uncorrected severe valvular heart disease (severe aortic, tricuspid, or mitral stenosis)
  10. 10. Recent exacerbation of congestive heart failure (requiring hospitalization, within 6 months)
  11. 11. Acute pulmonary embolism or deep vein thrombosis (within past 6 months)
  12. 12. Uncontrolled pulmonary edema
  13. 13. Uncontrolled symptomatic arrhythmias
  14. 14. Active endocarditis
  15. 15. Acute myocarditis or pericarditis
  16. 16. Active wheezing or home oxygen use
  17. 17. Recent exacerbation of chronic obstructive pulmonary disease or asthma or pneumonia (requiring hospitalization, within 6 months)
  18. 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. 19. Diagnosis of vertigo
  20. 20. Known allergic reactions to components of the SHAPE medical system apparatus disposable mouthpiece.
  21. 21. Active enrollment in an interventional clinical trial within the enrollment period of the study.

Contacts and Locations

Study Contact

Zyad J Carr, M.D.
CONTACT
203-785-3689
zyad.carr@yale.edu

Principal Investigator

Zyad J Carr, M.D.
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Yale University

  • Zyad J Carr, M.D., PRINCIPAL_INVESTIGATOR, Yale University

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 Registration Dates

Study Start Date2023-05-03
Study Completion Date2026-05-29

Study Record Updates

Study Start Date2023-05-03
Study Completion Date2026-05-29

Terms related to this study

Keywords Provided by Researchers

  • perioperative risk stratification
  • submaximal cardiopulmonary exercise testing
  • postoperative complications
  • perioperative complications

Additional Relevant MeSH Terms

  • Perioperative/Postoperative Complications
  • Aerobic Capacity