Cardiorespiratory FitnessPOPENCT05092126
Development & Validation of Preoperative Objective Physiological Evaluation
A study testing Exercise in people with Cardiorespiratory Fitness, run by Duke University at 1 site in United States.
Trial summary
This study will compare the measured oxygen consumption (VO2) obtained during sub-maximal exercise testing with the estimated VO2 derived from a non-exercise questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiorespiratory Fitness
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2021to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- Diagnosed history of dementia
- Inability to ambulate independently
- Considered inappropriate to participate by Principal Investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ashley Burke, BS contact
United States1 site, 1 recruiting
- Recruiting
Duke University Health System
Durham, North Carolina, 27710
David B MacLeod, FRCA, 919-812-3201, david.macleod@duke.edu
David B MacLeod, FRCA
About this study
This study will compare the measured oxygen consumption (VO2) obtained during sub-maximal exercise testing with the estimated VO2 derived from a non-exercise questionnaire.
Read the detailed description
All surgical patients presenting at the Preoperative Anesthesia \& Surgical Screening (PASS Clinic) will complete the Duke Activity Status Index (DASI) self-reported questionnaire as standard of care. If the DASI score is 34 or greater, the patients will not be considered for the study. If the DASI score is 33 or lower, the patient will be considered as a potential study participant. Eligible study participants will then complete a sub-maximal exercise test (Six Minute Step Test, 6MST) with measured VO2.
The VO2 is an integral part of preoperative assessment of cardiorespiratory fitness (CRF). A low CRF is associated with a higher incidence of post-operative complications and mortality. The study will evaluate the ability to estimate VO2 from exercise-derived measurement with questionnaire-derived estimation.
- Conditions
- Cardiorespiratory Fitness
- Being tested
- Exercise
- Keywords
- areobic power, cardiopulmonary exercise testing, exercise capacity, functional capacity, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Calculate oxygen consumption
| Study group | Role | What they receive |
|---|---|---|
| 6MST VO2 | Active comparator | Completion of 6MST exercise protocol Receives: Behavioral: Exercise |
| DASI VO2 | Active comparator | Completion of DASI fitness activity questionnaire Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of oxygen consumed per minute
Oxygen consumption measured in mL/min
Measured: Up to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start23 Nov 2021
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorespiratory FitnessStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- All subjects will be asked to complete the exercise test and the fitness questionnaire
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David MacLeod, FRCA, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092126
- Sponsor's protocol ID
- Pro00108789
- Acronym
- POPE
- Status last verified
- Apr 2026
- First submitted
- 12 Oct 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development & Validation of Preoperative Objective Physiological Evaluation
- ClinicalTrials.gov ID
- NCT05092126
- Acronym / sponsor ID
- POPE / Pro00108789
- Conditions
- Cardiorespiratory Fitness
- Keywords
- areobic power, cardiopulmonary exercise testing, exercise capacity, functional capacity, physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the measured oxygen consumption (VO2) obtained during sub-maximal exercise testing with the estimated VO2 derived from a non-exercise questionnaire.
Detailed description
All surgical patients presenting at the Preoperative Anesthesia \& Surgical Screening (PASS Clinic) will complete the Duke Activity Status Index (DASI) self-reported questionnaire as standard of care. If the DASI score is 34 or greater, the patients will not be considered for the study. If the DASI score is 33 or lower, the patient will be considered as a potential study participant. Eligible study participants will then complete a sub-maximal exercise test (Six Minute Step Test, 6MST) with measured VO2.
The VO2 is an integral part of preoperative assessment of cardiorespiratory fitness (CRF). A low CRF is associated with a higher incidence of post-operative complications and mortality. The study will evaluate the ability to estimate VO2 from exercise-derived measurement with questionnaire-derived estimation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All subjects will be asked to complete the exercise test and the fitness questionnaire
| Arm | Type | Receives |
|---|---|---|
| 6MST VO2 | Active comparator | Behavioral: ExerciseCompletion of 6MST exercise protocol |
| DASI VO2 | Active comparator | Behavioral: ExerciseCompletion of DASI fitness activity questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseCalculate oxygen consumption | Behavioural | 6MST VO2, DASI VO2 |
Primary outcome
Total amount of oxygen consumed per minute
Time frame: Up to 15 minutes
Oxygen consumption measured in mL/min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley Burke, BS contact
David MacLeod, FRCA principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cardiorespiratory Fitness, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David MacLeod, FRCA (919-812-3201, david.macleod@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of oxygen consumed per minute (time frame: Up to 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.