Functional Incremental Stepping in Place Test (F-IST) Validation

NCT06853236 | Recruiting

• 2 other identifiers: 863901000400362
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Modified Bruce Treadmill VO2 Peak

  Peak oxygen consumption during the modified Bruce cardiorespiratory test using a PARVO metabolic cart

  Upon enrollment at baseline (day 0-7)

• F-IST VO2 Peak

  Peak oxygen consumption during the F-IST cardiorespiratory test using a PARVO metabolic cart

  Upon enrollment at baseline (day 0-7)

• F-IST VO2 Peak Reliability

  Peak oxygen consumption during the F-IST cardiorespiratory test using a PARVO metabolic cart

  Approximately 1-2 weeks following baseline (day 14-21)

Secondary Outcomes (9)

• 6MWT distance

  Approximately 1-2 weeks following baseline (day 14-21)

• 4m habitual gait speed

  Approximately 1-2 weeks following baseline (day 14-21)

• Sit to Stand Test (5x)

  Approximately 1-2 weeks following baseline (day 14-21)

• Sit to Stand Test (30 seconds)

  Approximately 1-2 weeks following baseline (day 14-21)

• EQ5D-5L Questionnaire

  Approximately 1-2 weeks following baseline (day 14-21)

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This project may include adults aged 18 and older without regard to sex, race, or ethnicity. Exclusions will include pregnancy and vulnerable groups such as children, prisoners, adults with impaired consent capacity or are non-English speaking. All participation must be on a voluntary basis.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida Atlantic University: collaborator
• Kirby Mayer: lead
• Duke University: collaborator

Study Sites (2)

Florida Atlantic University

Boca Raton, Florida, 33431, United States

RECRUITING

Duke University

Durham, North Carolina, 27708, United States

RECRUITING

Central Study Contacts

Research Associate Senior

CONTACT

859-323-5438; delong2@uky.edu

Primary Investigator

CONTACT

859-218-0596; kpmaye2@uky.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 28, 2025
• Study Start: July 2, 2024
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): July 2, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: IPD will be available at the time of manuscript acceptance and publishing. A published manuscript is planned for late 2026.
• Access Criteria: Any external researcher will be able to access de-identified, non, PHI, individual participant data as part of the journal's supplementary information.

Locations

US (2)