Functional Incremental Stepping in Place Test (F-IST) Validation
NCT ID: NCT06853236
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2024-07-02
2026-02-28
Brief Summary
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Detailed Description
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Common physiological consequences associated with HAD are diminished skeletal muscle function and cardiorespiratory fitness (CRF). Historically, the six-minute walk test (6MWT) has been utilized as a chief outcome measure in the acute hospitalization and post-discharge phases to examine functional exercise capacity, estimate maximal capacity, and prescribe exercise intervention. The 6MWT is a submaximal field test that allows patients to self-select their walking pace and may be influenced by several factors including motivation. The internally-selected pace coupled with the lack of incremental increases in intensity can underrepresent CRF. In addition, the test requires a 30-meter straight course, which can be challenging to find in the hospital environment. Thus, to address the limitations of submaximal field tests, our team developed the Functional-Incremental Stepping-in-place Test (F-IST).
Designed to objectively examine CRF across the variety of patients encountered in clinical practice, the F-IST is an incremental, externally-paced, symptom-limited stepping-in-place test. While maintaining the graded components of gold standard cardiopulmonary exercise testing (CPET), it has high clinical utility since it requires minimal equipment (UE support allowed), minimal space (performed at bedside), and short administration time (\< 10 min). Also, the incremental increase in intensity is individualized to perceived exertion and heart rate responses during test stages, which ultimately enables precise exercise prescription. Preliminary data on F-IST from the ongoing randomized controlled trial (NCT05218083) demonstrate potential for strong construct validity when compared to 6MWT (n = 9, spearman rho = 0.65, p = 0.05). However, before implementation in clinical practice, a new test requires the study of its measurement properties to assure that its selection is evidence-based.
Findings from this study will demonstrate that F-IST is a robust valid and reliable assessment of CRF that can be implemented on the frontline of acute care physical therapy. The F-IST addresses important limitations of field tests with an enhanced rigor by maintaining principles of gold-standard CPET. The F-IST will enable clinicians and researchers to provide precision exercise prescription to optimize patient function.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Healthy
Community-dwelling older adults (≥60 years) with no recent hospitalization
No interventions assigned to this group
ICU Survivor
Patients who survived ICU admission for ARF or sepsis in the last year
No interventions assigned to this group
Chronic Pulmonary Disease
Community-dwelling adults with diagnosis of COPD, ILD, or PF
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
ALL
Yes
Sponsors
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Duke University
OTHER
Florida Atlantic University
OTHER
University of Kentucky
OTHER
Responsible Party
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Kirby Mayer
Associate Professor
Locations
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Florida Atlantic University
Boca Raton, Florida, United States
Duke University
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Principal Investigator
Role: primary
Principal Investigator
Role: primary
Other Identifiers
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1000400362
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
86390
Identifier Type: -
Identifier Source: org_study_id