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| ID | Type | Description | Link |
|---|---|---|---|
| 1000400362 | Other Grant/Funding Number | Foundation for Physical Therapy |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| Florida Atlantic University | OTHER |
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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.
Acutely hospitalized patients are at risk for hospital-acquired functional decline (HAD). This decline increases the likelihood of developing physical disability after discharge, particularly in those with older age, multimorbidity, pre-existing functional impairment and life support exposures (i.e. mechanical ventilation). Identifying patients at increased risk provides important prognostic data to inform planning strategies for both in-hospital and post-acute intervention.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 6MWT distance | Six minute walking test distance in meters | Approximately 1-2 weeks following baseline (day 14-21) |
| 4m habitual gait speed | Habitual gait speed across a 4 meter distance |
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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
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Associate Senior | Contact | 859-323-5438 | delong2@uky.edu | |
| Primary Investigator | Contact | 859-218-0596 | kpmaye2@uky.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Atlantic University | Recruiting | Boca Raton | Florida | 33431 | United States |
The dissemination plan emphasizes transparency of the study, and as a study team, the investigators are committed to sharing de-identified data for external researchers.
IPD will be available at the time of manuscript acceptance and publishing. A published manuscript is planned for late 2026.
Any external researcher will be able to access de-identified, non, PHI, individual participant data as part of the journal's supplementary information.
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| Approximately 1-2 weeks following baseline (day 14-21) |
| Sit to Stand Test (5x) | Time in seconds it takes to rise and sit from a chair 5 times | Approximately 1-2 weeks following baseline (day 14-21) |
| Sit to Stand Test (30 seconds) | The number of full repetitions completed to rise and sit from a chair over 30 seconds | Approximately 1-2 weeks following baseline (day 14-21) |
| EQ5D-5L Questionnaire | Health related quality of life scale patient reported outcome | Approximately 1-2 weeks following baseline (day 14-21) |
| Visual Analog Scale Questionnaire | Health related quality of life scale patient reported outcome | Approximately 1-2 weeks following baseline (day 14-21) |
| FACIT-fatigue Questionnaire | Patient reported outcome indicating fatigue | Approximately 1-2 weeks following baseline (day 14-21) |
| SF-36 Questionnaire | Patient reported outcome indicating eight different domains of health | Approximately 1-2 weeks following baseline (day 14-21) |
| St. George's Respiratory Questionnaire | Patient reported outcome measuring impact of overall health, daily life, and respiratory systems | Approximately 1-2 weeks following baseline (day 14-21) |
| Duke University | Recruiting | Durham | North Carolina | 27708 | United States |
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