Functional Incremental Stepping in Place Test (F-IST) Validation
Recruiting now
Conditions studied: Intensive Care Medicine, Acute Care Medical
In brief
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.
Key facts
- Study ID
- NCT06853236
- Run by
- Kirby Mayer
- People needed
- 60
- Starts
- 2024-07-02
- Expected to finish
- 2027-02-27
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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
- 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
Where it is running
- Florida Atlantic University — Boca Raton, Florida, United States (enrolling)
- Duke University — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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