NCT06853236 Functional Incremental Stepping in Place Test (F-IST) Validation
| NCT ID | NCT06853236 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kirby Mayer |
| Condition | Intensive Care Medicine |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-07-02 |
| Primary Completion | 2026-07-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-07-02 with a primary completion date of 2026-07-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06853236 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intensive Care Medicine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06853236 currently recruiting?
Yes, NCT06853236 is actively recruiting participants. Contact the research team at delong2@uky.edu for enrollment information.
Where is the NCT06853236 trial being conducted?
This trial is being conducted at Boca Raton, United States, Durham, United States.
Who is sponsoring the NCT06853236 clinical trial?
NCT06853236 is sponsored by Kirby Mayer. The trial plans to enroll 60 participants.