Intelligent Lung Support in the Intensive Care Unit
NCT06595602
Intensive Care Medicine, Mechanical Ventilation
Dresden, Germany
View Trial DetailsNCT Number: NCT06853236
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Florida Atlantic University, Boca Raton, Florida, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Time frame: Upon enrollment at baseline (day 0-7)
Peak oxygen consumption during the modified Bruce cardiorespiratory test using a PARVO metabolic cart
Time frame: Upon enrollment at baseline (day 0-7)
Peak oxygen consumption during the F-IST cardiorespiratory test using a PARVO metabolic cart
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
Peak oxygen consumption during the F-IST cardiorespiratory test using a PARVO metabolic cart
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
Six minute walking test distance in meters
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
Habitual gait speed across a 4 meter distance
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
Time in seconds it takes to rise and sit from a chair 5 times
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
The number of full repetitions completed to rise and sit from a chair over 30 seconds
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
Health related quality of life scale patient reported outcome
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
Health related quality of life scale patient reported outcome
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
Patient reported outcome indicating fatigue
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
Patient reported outcome indicating eight different domains of health
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
Patient reported outcome measuring impact of overall health, daily life, and respiratory systems
Contact information is provided by the study sponsor or research team.
Primary Investigator
CONTACT
Research Associate Senior
CONTACT
Kirby Mayer
Other
A Cardiorespiratory Fitness Test for Acute Illness: Validity, Reliability, and Clinical Utility of Functional Incremental Stepping-in-Place Test
Acronym: F-IST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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