Development & Validation of Preoperative Objective Physiological Evaluation

NCT05092126 | Recruiting

• 1 other identifier: Pro00108789
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Total amount of oxygen consumed per minute

  Oxygen consumption measured in mL/min

  Up to 15 minutes

Study Arms (2)

6MST VO2

ACTIVE COMPARATOR

Completion of 6MST exercise protocol

Behavioral: Exercise

DASI VO2

ACTIVE COMPARATOR

Completion of DASI fitness activity questionnaire

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Calculate oxygen consumption

6MST VO2; DASI VO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David MacLeod, FRCA

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David MacLeod, FRCA

CONTACT

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

Ashley Burke, BS

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will be asked to complete the exercise test and the fitness questionnaire

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: November 23, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)