Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT05092126

Conditions

Cardiorespiratory Fitness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

Brief 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.

Conditions

Cardiorespiratory Fitness

Study ID

NCT05092126

Start date

Nov 23, 2021

Status verified date

Apr, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: 6MST VO2

Completion of 6MST exercise protocol

active comparator: DASI VO2

Completion of DASI fitness activity questionnaire

Interventions

Exercise

Calculate oxygen consumption

Primary outcome measure

  • Total amount of oxygen consumed per minute [ Time Frame: Up to 15 minutes ]

Central Contacts and Locations

Central contacts

David MacLeod, FRCA

919-812-3201david.macleod@duke.edu

Locations

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27710

Contacts

David B MacLeod, FRCA

919-812-3201david.macleod@duke.edu

Principal Investigator:

David B MacLeod, FRCA

More Information

Sponsor

Duke University

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

  • areobic power
  • cardiopulmonary exercise testing
  • exercise capacity
  • functional capacity
  • physical activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-04-27.