Recruiting

Observational Study

Sponsor:

Kirby Mayer

Code:

NCT06853236

Conditions

Intensive Care Medicine

Acute Care Medical

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The purpose of this multi-site prospective study is to assess validity of a new step test called Functional-Incremental Stepping-in-place- Test (F-IST) compared to gold-standard cardiopulmonary exercise testing (CPET) and to physical function and health perception, respectively. The investigators will also assess test-retest reliability of the F-IST. The investigators hypothesize that the F-IST will have high validity and test-retest reliability to be used in field testing environments such as the ICU.

Conditions

Intensive Care Medicine

Acute Care Medical

Study ID

NCT06853236

Start date

Jul 2, 2024

Status verified date

Jul, 2026

Completion date

Feb 27, 2027

Anticipated

Primary completion date

Feb 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

-Currently able to walk with or without a walking aid, such as a cane or walker or rollator

Exclusion Criteria:

Pregnancy

specifically related to cardiopulmonary testing

  • A recent significant change in resting ECG
  • Unstable angina
  • Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
  • Symptomatic severe aortic stenosis
  • Uncontrolled symptomatic heart failure
  • Acute pulmonary embolus or pulmonary infarction
  • Acute myocarditis or pericarditis
  • Suspected or known dissecting aneurysm
  • Acute systemic infection accompanied by fever, body aches, or swollen lymph glands
  • Left Main Coronary Stenosis
  • Moderate stenotic valvular heart disease
  • Electrolyte abnormalities
  • Severe arterial hypertension (>200 systolic, >110 diastolic) at rest
  • Tachydysrhythmia or bradydysrhythmia
  • Hypertrophic cardiomyopathy and other forms of outflow tract obstruction
  • Neuromuscular, musculoskeletal, or rheumatic disorders that are exacerbated by exercise
  • High degree AV block
  • Ventricular aneurysm
  • Uncontrolled metabolic disease (diabetes, thyrotoxicosis, or myxedema)
  • Chronic infectious disease (hepatitis, AIDS, mono)
  • Mental or physical impairment leading to inability to exercise adequately

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy

Community-dwelling older adults (≥60 years) with no recent hospitalization

ICU Survivor

Patients who survived ICU admission for ARF or sepsis in the last year

Chronic Pulmonary Disease

Community-dwelling adults with diagnosis of COPD, ILD, or PF

Primary outcome measure

  • Modified Bruce Treadmill VO2 Peak [ Time Frame: Upon enrollment at baseline (day 0-7) ]
  • F-IST VO2 Peak [ Time Frame: Upon enrollment at baseline (day 0-7) ]
  • F-IST VO2 Peak Reliability [ Time Frame: Approximately 1-2 weeks following baseline (day 14-21) ]

Central Contacts and Locations

Central contacts

Research Associate Senior

859-323-5438delong2@uky.edu

Primary Investigator

859-218-0596kpmaye2@uky.edu

Locations

Florida Atlantic University

Recruiting

Boca Raton, Florida, United States, 33431

Contacts

Principal Investigator

(561) 297-2938aartese@fau.edu

Principal Investigator:

Ashley Artese, PhD

Duke University

Recruiting

Durham, North Carolina, United States, 27708

Contacts

Principal Investigator

919-681-3595amy.pastva@duke.edu

Principal Investigator:

Amy Pastva, PT, MA, PhD

More Information

Sponsor

Kirby Mayer

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • Cardio respiratory fitness
  • incremental step test
  • validity
  • reliability
  • physical function
  • graded exercise testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kirby Mayer on 2026-07-20.