Evaluating preoperative fitness using exercise tests and questionnaires
Official title: Development & Validation of Preoperative Objective Physiological Evaluation
Run by Duke University · NCT05092126 · Data updated 2026-11-12
This study is testing if a simple questionnaire can accurately estimate fitness levels in surgical patients by comparing it to a physical exercise test.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | November 23, 2021 |
| Main results expected | March 1, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT05092126 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are undergoing preoperative assessment and have a DASI score of less than 34.
✕Probably not a fit
Patients with acute myocardial infarction, unstable angina, severe untreated hypertension, or other significant health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the oxygen consumption (VO2) measured during a sub-maximal exercise test with the VO2 estimated from a self-reported questionnaire in surgical patients. Patients at the Preoperative Anesthesia & Surgical Screening Clinic will complete the Duke Activity Status Index (DASI) questionnaire, and those with a score of 33 or lower will be eligible for the study. Eligible participants will then undergo a Six Minute Step Test (6MST) to measure their VO2. The goal is to assess the accuracy of questionnaire-derived estimates of cardiorespiratory fitness in predicting surgical outcomes.
Why it matters
Potential benefit: If successful, this study could improve preoperative assessments and reduce postoperative complications by providing a more accurate evaluation of patients' cardiorespiratory fitness.
How similar studies have gone: Other studies have shown promise in using exercise testing to evaluate cardiorespiratory fitness, making this approach both relevant and potentially impactful.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 and older * Able to speak English * Ambulatory \[assistive devices ok\] * Preoperative Anesthesia and Surgical Screening (PASS) clinic patient with DASI score \<34 * Able to provide informed consent Exclusion Criteria: * Acute myocardial infarction (3-5 days) * Unstable angina * Severe untreated arterial hypertension at rest (\>200 mm Hg systolic, \>120 mm Hg diastolic) * Resting heart rate \> 120 bpm * Room air desaturation at rest on room air \<85% * Inmate of correctional facility (i.e. prisoner) * Diagnosed history of dementia * Inability to ambulate independently * Considered inappropriate to participate by Principal Investigator
Where it's running
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Duke University Health System
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: David MacLeod, FRCA — Duke University
- Study coordinator: David MacLeod, FRCA
- Email: david.macleod@duke.edu
- Phone: 919-812-3201
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.