Actively Recruiting

Age: 60Years +
All Genders
Healthy Volunteers
ID05743673

A Feasibility Study of the SHAPE17 Test of Aerobic Fitness in Older Adults Presenting for Moderate to High-risk Surgery

Led by Yale University · Updated on 2026-05-07

371

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying whether the SHAPE-HF cardiopulmonary testing system can be used before surgery to better assess heart, lung, and overall physical fitness in adults over 60 years old. This system aims to provide an objective and simplified way to measure aerobic fitness before moderate- to high-risk noncardiac surgery. The study compares this new testing method with traditional ways of estimating fitness, such as patient questionnaires and self-reported activity levels. Participants will attend one in-person visit lasting about 35 minutes during their preoperative evaluation. During this visit, they will complete the SHAPE-HF submaximal exercise test along with standard assessments like the Duke Activity Status Index and subjective metabolic equivalent (MET) evaluations. Around 24 hours after testing, researchers will follow up by phone to check for any issues. After surgery, medical records will be reviewed for 30 days to see how test results relate to recovery, short-term health problems, and major complications. Throughout the study, participants will provide information about their activity levels and undergo testing to measure aerobic fitness objectively. Researchers will assess recruitment success, compare SHAPE-HF results to conventional fitness measures, and track postoperative outcomes including major cardiovascular events and complications. This study does not change planned surgery or care but seeks to improve risk assessment for older adults undergoing moderate- to high-risk surgery.

CONDITIONS

Brief Title

SHAPE Test for Preoperative Risk Stratification

Who Can Participate

Age: 60Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged over 60 years
  • Scheduled for pre-surgical evaluation for moderate to high-risk surgical procedure
  • Revised Cardiac Risk Index (RCRI) score less than 2
  • Able to provide signed and dated informed consent
Not Eligible

You will not qualify if you...

  • Age under 60 years
  • Subjective metabolic equivalents (METS) less than 4
  • Unable to give independent informed consent
  • Revised Cardiac Risk Index (RCRI) greater than 2
  • Neurological impairment with motor limitations
  • Mental impairment preventing cooperation
  • Recent heart attack within 6 months
  • Angina within 6 months
  • Severe uncorrected heart valve disease
  • Recent congestive heart failure requiring hospitalization within 6 months
  • Recent pulmonary embolism or deep vein thrombosis within 6 months
  • Uncontrolled pulmonary edema
  • Uncontrolled symptomatic heart rhythm problems
  • Active infection of the heart lining
  • Recent myocarditis or pericarditis
  • Active wheezing or use of home oxygen
  • Recent worsening of lung diseases requiring hospitalization within 6 months
  • Inability to perform the SHAPE test due to severe joint or mobility issues
  • Diagnosis of vertigo
  • Known allergies to components of the SHAPE test mouthpiece
  • Currently enrolled in another interventional clinical trial during study enrollment period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for pre-surgical evaluation and eligibility assessment

Diagnostic Evaluation

Duration - 1 day

Participants complete a single in-person visit during which conventional preoperative functional assessments and the SHAPE-HF submaximal cardiopulmonary exercise test are performed to objectively assess aerobic fitness before surgery.

1 visit (in-person) lasting approximately 35 minutes during the preoperative period

Follow-up

Duration - 30 days

Participants receive a telephone follow-up approximately 24 hours after testing to assess for any adverse events related to the procedure, followed by postoperative follow-up through medical record review for 30 days after surgery to monitor clinical outcomes.

1 telephone follow-up contact and medical record review over 30 days post-surgery

Trial Site Locations

Total: 1 location

1

Yale New Haven Hospital

New Haven, Connecticut, United States, 06520

Actively Recruiting

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Research Team

Z

Zyad J Carr, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Heart rate recovery and morbidity after noncardiac surgery: Planned secondary analysis of two prospective, multi-centre, blinded observational studies.

Gareth L Ackland, Tom E F Abbott, Gary Minto...

https://pubmed.ncbi.nlm.nih.gov/31433825

Submaximal heart and pulmonary evaluation: a novel noninvasive test to identify pulmonary hypertension in patients with systemic sclerosis.

Elana J Bernstein, Lisa A Mandl, Jessica K Gordon...

https://pubmed.ncbi.nlm.nih.gov/23740875

Perioperative cardiac events in patients undergoing noncardiac surgery: a review of the magnitude of the problem, the pathophysiology of the events and methods to estimate and communicate risk.

P J Devereaux, Lee Goldman, Deborah J Cook...

https://pubmed.ncbi.nlm.nih.gov/16157727

Prediction of cardiac and pulmonary complications related to elective abdominal and noncardiac thoracic surgery in geriatric patients.

M C Gerson, J M Hurst, V S Hertzberg...

https://pubmed.ncbi.nlm.nih.gov/2301435