Functional Incremental Stepping in Place Test (F-IST) Validation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKirby Mayer
About this trial
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
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
A recent significant change in resting ECG
Unstable angina
Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
Symptomatic severe aortic stenosis
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 3 trial groupsGroup A: Healthy
Group B: ICU Survivor
Group C: Chronic Pulmonary Disease
Trial outcomes
Primary outcomes
1
Modified Bruce Treadmill VO2 Peak
Peak oxygen consumption during the modified Bruce cardiorespiratory test using a PARVO metabolic cart
Time frame
Upon enrollment at baseline (day 0-7)2
F-IST VO2 Peak
Peak oxygen consumption during the F-IST cardiorespiratory test using a PARVO metabolic cart
Time frame
Upon enrollment at baseline (day 0-7)3
F-IST VO2 Peak Reliability
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)Secondary outcomes
1
6MWT distance
Six minute walking test distance in meters
Time frame
Approximately 1-2 weeks following baseline (day 14-21)2
4m habitual gait speed
Habitual gait speed across a 4 meter distance
Time frame
Approximately 1-2 weeks following baseline (day 14-21)3
Sit to Stand Test (5x)
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)4
Sit to Stand Test (30 seconds)
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kirby Mayer
Lead sponsor
University of Kentucky
Sponsor institution
Duke University
Collaborator
Florida Atlantic University
Collaborator
Source ClinicalTrials.gov