Intensive Care MedicineF-ISTNCT06853236
Functional Incremental Stepping in Place Test (F-IST) Validation
An observational study of Intensive Care Medicine and Acute Care Medical, run by Kirby Mayer at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Medicine, Acute Care Medical
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jul 2024to 27 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- -Currently able to walk with or without a walking aid, such as a cane or walker or rollator
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Florida Atlantic University
Boca Raton, Florida, 33431
Duke University
Durham, North Carolina, 27708
About this study
Official title: A Cardiorespiratory Fitness Test for Acute Illness: Validity, Reliability, and Clinical Utility of Functional Incremental Stepping-in-Place Test
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.
Read the detailed description
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.
- Conditions
- Intensive Care Medicine, Acute Care Medical
- Keywords
- Cardio respiratory fitness, incremental step test, validity, reliability, physical function, graded exercise testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Bruce Treadmill VO2 Peak
Peak oxygen consumption during the modified Bruce cardiorespiratory test using a PARVO metabolic cart
Measured: 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
Measured: 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
Measured: Approximately 1-2 weeks following baseline (day 14-21)
Secondary outcomes (9)
6MWT distance
Six minute walking test distance in meters
Measured: Approximately 1-2 weeks following baseline (day 14-21)
4m habitual gait speed
Habitual gait speed across a 4 meter distance
Measured: 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
Measured: 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
Measured: Approximately 1-2 weeks following baseline (day 14-21)
EQ5D-5L Questionnaire
Health related quality of life scale patient reported outcome
Measured: Approximately 1-2 weeks following baseline (day 14-21)
Visual Analog Scale Questionnaire
Health related quality of life scale patient reported outcome
Measured: Approximately 1-2 weeks following baseline (day 14-21)
FACIT-fatigue Questionnaire
Patient reported outcome indicating fatigue
Measured: Approximately 1-2 weeks following baseline (day 14-21)
SF-36 Questionnaire
Patient reported outcome indicating eight different domains of health
Measured: 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
Measured: Approximately 1-2 weeks following baseline (day 14-21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start2 Jul 2024
- Primary completion23 Jul 2026
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Mayer
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Florida Atlantic University
- Responsible party
- Sponsor-investigator, Kirby Mayer, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853236
- Sponsor's protocol ID
- 86390
- Other IDs
- 1000400362
- Acronym
- F-IST
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cardiorespiratory Fitness Test for Acute Illness: Validity, Reliability, and Clinical Utility of Functional Incremental Stepping-in-Place Test
- ClinicalTrials.gov ID
- NCT06853236
- Acronym / sponsor ID
- F-IST / 86390
- Conditions
- Intensive Care Medicine, Acute Care Medical
- Keywords
- Cardio respiratory fitness, incremental step test, validity, reliability, physical function, graded exercise testing
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kirby MayerUniversity, hospital or other
- Collaborators
- Duke University, Florida Atlantic University
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 27 Feb 2027 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (1 listed)
- -Currently able to walk with or without a walking aid, such as a cane or walker or rollator
Key exclusion criteria (23 listed)
- Pregnancy
- specifically related to cardiopulmonary testing
- A recent significant change in resting ECG
- Unstable angina
- Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Bruce Treadmill VO2 Peak
Time frame: Upon enrollment at baseline (day 0-7)
Peak oxygen consumption during the modified Bruce cardiorespiratory test using a PARVO metabolic cart
F-IST VO2 Peak
Time frame: Upon enrollment at baseline (day 0-7)
Peak oxygen consumption during the F-IST cardiorespiratory test using a PARVO metabolic cart
F-IST VO2 Peak Reliability
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
9 secondary outcomes
6MWT distance
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
4m habitual gait speed
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
Sit to Stand Test (5x)
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
Sit to Stand Test (30 seconds)
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
EQ5D-5L Questionnaire
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
Visual Analog Scale Questionnaire
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
FACIT-fatigue Questionnaire
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
SF-36 Questionnaire
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
St. George's Respiratory Questionnaire
Time frame: Approximately 1-2 weeks following baseline (day 14-21)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Intensive Care Medicine
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
RecruitingObservational study
Microbiome and Enteric Signatures in Sepsis-associated Hepatorenal Injury
Sepsis, Acute Kidney Injury Due to Sepsis
RecruitingObservational study
B Lymphocyte Populations in the Pulmonary Microenvironment of Patients Under Mechanical Ventilation With or Without VAP (Ventilator-Associated Pneumonia)
Ventilator-associated Pneumonia
Not yet recruiting
Resistance-Optimised Antimicrobial Dosing in Critically Ill Patients, a Randomised Controlled Trial
Hospital-acquired Pneumonia (HAP), Ventilator-Associated Pneumonia (VAP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Medicine and Acute Care Medical, run by Kirby Mayer at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Bruce Treadmill VO2 Peak (time frame: Upon enrollment at baseline (day 0-7)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.