Validation of a new step test for assessing physical function in hospitalized patients
A Cardiorespiratory Fitness Test for Acute Illness: Validity, Reliability, and Clinical Utility of Functional Incremental Stepping-in-Place Test
This study is trying out a new step test to see if it can accurately measure how well hospitalized patients are doing physically, especially in the ICU.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 2 sites (Boca Raton, Florida and 1 other locations) |
| Trial ID | NCT06853236 on ClinicalTrials.gov |
What this trial studies
This multi-site observational study aims to validate the Functional-Incremental Stepping-in-place Test (F-IST) against the gold-standard cardiopulmonary exercise testing (CPET) in acutely hospitalized patients. The study will assess the test's validity and reliability, focusing on its ability to measure cardiorespiratory fitness and physical function in a clinical setting, particularly in the ICU. By identifying patients at risk of hospital-acquired functional decline, the study seeks to provide valuable prognostic data for in-hospital and post-acute interventions.
Who should consider this trial
Good fit: Ideal candidates include acutely hospitalized patients who are currently able to walk with or without assistance.
Not a fit: Patients with significant cardiopulmonary conditions or other severe health issues that prevent safe participation in physical testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment of physical function in hospitalized patients, potentially reducing the risk of long-term disability.
How similar studies have performed: While the F-IST is a novel approach, similar studies using incremental exercise tests have shown promise in assessing physical function in various patient populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boca Raton, Florida and 1 other locations
- Florida Atlantic University — Boca Raton, Florida, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Research Associate Senior
- Email: delong2@uky.edu
- Phone: 859-323-5438
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.