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Can a 35-Minute exercise test predict surgery risks in seniors?

NCT ID NCT05743673

Knowledge-focused Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at whether a quick, low-intensity exercise test called SHAPE™ can help doctors assess fitness in adults over 60 before moderate- to high-risk surgery. About 371 participants will take the test and answer questions about their activity level. Researchers will then check medical records for 30 days after surgery to see if test results relate to recovery or complications. The goal is to see if this test is practical and useful in a busy pre-surgery clinic.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SHAPE-HF cardiopulmonary exercise testing device
What this could lead to
If successful, this could give doctors a simple, objective way to measure fitness in older adults before surgery, helping to predict and reduce complications.
What could go wrong
This is an early feasibility study, not a treatment trial. The test may not prove useful or practical in busy clinics, and results may not improve surgical outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 371 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Postoperative Complications

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aerobic capacity Perioperative/postoperative complications

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06520, United States

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Other studies related to the condition(s) this trial covers.