Cardiorespiratory FitnessVALID-ISTNCT07829003
Validation of a Novel Incremental Step Test for Assessment of Cardiopulmonary Fitness and Ventilatory Thresholds in Adults
A study testing Cardiopulmonary Exercise Test and Incremental Step Test in people with Cardiorespiratory Fitness and Metabolic Health, run by Heriot-Watt University at 1 site in United Kingdom.
Trial summary
The purpose of this single-group diagnostic validation and test-retest reliability study is to determine whether a novel Incremental Step Test (IST) can accurately assess cardiorespiratory fitness and ventilatory thresholds in healthy adults compared with an established laboratory-based cycle ergometer Cardiopulmonary… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiorespiratory Fitness, Metabolic Health, Cardiac Function
- What is being tested?
- Cardiopulmonary Exercise Test and Incremental Step Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jul 2026to 30 Oct 2026
- Phase
- Interventional
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to 55 years.
- Body mass index between 18.5 and 29.9 kg/m².
- Non-smoker.
- No known cardiovascular, respiratory, metabolic, neurological, or musculoskeletal conditions that would contraindicate maximal exercise testing.
- Able to provide written informed consent.
- Willing and able to complete one Cardiopulmonary Exercise Test and two Incremental Step Test sessions.
Who cannot join
- Age younger than 18 years or older than 55 years.
- Body mass index below 18.5 kg/m² or above 29.9 kg/m².
- Current smoker or use of nicotine products.
- Known cardiovascular, respiratory, metabolic, neurological, or musculoskeletal conditions that may affect exercise performance or make maximal exercise testing unsafe.
- Any contraindication to maximal exercise testing according to established exercise testing guidelines.
- Use of medications known to significantly affect cardiovascular, respiratory, or metabolic responses to exercise.
Show all 11Show fewer
- Current injury, illness, or infection that may limit participation in exercise testing.
- Pregnancy.
- Inability to provide informed consent.
- Inability to complete study procedures or attend all required study visits.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Oriam Scotlant Performance Centre
Edinburgh, EH14 4AS
About this study
The purpose of this single-group diagnostic validation and test-retest reliability study is to determine whether a novel Incremental Step Test (IST) can accurately assess cardiorespiratory fitness and ventilatory thresholds in healthy adults compared with an established laboratory-based cycle ergometer Cardiopulmonary Exercise Test (CPET). The main questions are whether the step test can elicit reliable physiological responses sufficient to identify the anaerobic threshold and respiratory compensation point, and whether it produces reproducible results when repeated under standardised conditions. The study will compare the incremental step test (IST) with CPET to assess whether the IST provides similar peak and submaximal physiological measures and agreement with CPET comparator. Participants will complete three laboratory exercise tests across separate visits: one maximal CPET on a cycle ergometer, followed by two repeated ISTs performed on a 25 cm step board following the audio metronome.
Read the detailed description
Participants will attend three laboratory visits separated by at least 3 days and conducted at similar times of the day. The first visit will include screening, anthropometric assessment, and a maximal CPET on an electronically braked cycle ergometer using a ramp protocol of 25 W/min for males and 20 W/min for females. Participants will complete 3 minutes of unloaded cycling followed by incremental protocol while maintaining the cadence at least 60 rpm, and the test will be terminated if they can no longer can sustain this cadence. Following CPET, participants will complete a 6-minute familiarisation session to practise the stepping activity, including the up-up-down-down stepping technique and alternation of the leading leg every 2 minutes. The second and third visits will involve repeated IST trials performed on 25 cm step board, with cadence progressed from 20 beats per minute and increased by 4 beats per minute every 20 seconds until volitional exhaustion. The IST will be terminated if the participant is unable to maintain the prescribed stepping rhythm for more than 15 seconds. Continuous breath-by-breath gas exchange, ECG, and heart rate monitoring will be used during testing to characterise peak performance and ventilatory threshold responses. Agreement between the step test and CPET, as well as test-retest reproducibility of the IST, will be evaluated to determine whether the new protocol could support more individualised exercise prescription in stepping-based activities.
- Conditions
- Cardiorespiratory Fitness, Metabolic Health, Cardiac Function, Pulmonary Function, Exercise Test
- Being tested
- Cardiopulmonary Exercise Test, Incremental Step Test
- Keywords
- Cardiopulmonary Exercise Testing, CPET, Exercise testing, Incremental Step Test, VO2 peak, Ventilatory threshold, reliability, validation, gas exchange, anaerobic threshold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary Exercise TestDiagnostic test
A maximal incremental exercise test performed on a cycle ergometer with continuous breath-by-breath gas exchange and heart rate monitoring to assess cardiorespiratory fitness and physiological response
Incremental Step TestDiagnostic test
A progressive step test using a standardised 25 cm step platform. Participants will complete a 3-minute warm-up at 20 beats per minute before cadence increases by 4 beats per minute every 20 seconds until volitional exhaustion or predefined termination criteria are reached.
| Study group | Role | What they receive |
|---|---|---|
| Incremental Step Test Validation Protocol | Experimental | Participants will complete one laboratory-based Cardiopulmonary Exercise Test followed by two Incremental Step Test sessions conducted on separate visits. The first visit will include screening, anthropometric measurements, and a maximal incremental CPET on an electronically braked cycle ergometer using an individualised ramp protocol set at 25 W/min for males and 20 W/min for females, after 3 minutes of unloaded cycling. The second and third visits will involve two repeated incremental step tests on a standardised 25 cm step, with cadence starting at 20 beats per minute and increasing by 4 beats per minute every 20 seconds until volitional exhaustion. The CPET will be terminated if participants could not maintain a cadence of at least 60 rpm, and the step test will be terminated if participants could not maintain the prescribed stepping rhythm for 15 consecutive seconds. Exercise ECG, continuous heart rate, and breath-by-breath gas exchange will be recorded during all exercise tests. Receives: Diagnostic Test: Cardiopulmonary Exercise Test; Diagnostic Test: Incremental Step Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-method agreement in oxygen uptake at Anaerobic Threshold (AT)
Agreement between the Incremental Step Test and the established laboratory-based cycle ergometer Cardiopulmonary Exercise Test comparator for oxygen uptake at Anaerobic Threshold (mL/min), will be assessed using intraclass correlation coefficients and Bland-Altman analysis.
Measured: Baseline (Day 1-CPET) and IST assessments at Visits 2 and 3, scheduled at 3-7-day intervals.
Between-method agreement in oxygen uptake at Respiratory Compensation Point (RCP)
Agreement between the Incremental Step Test and the established laboratory-based cycle ergometer Cardiopulmonary Exercise Test comparator for oxygen uptake at Respiratory Compensation point / Ventilatory Threshold 2 (mL/min), will be assessed using intraclass correlation coefficients and Bland-Altman analysis.
Measured: Baseline (Day 1-CPET) and IST assessments at Visits 2 and 3, scheduled at 3-7-day intervals.
Between-method agreement in Peak Oxygen Uptake (VO2peak)
Peak oxygen uptake will be defined as the highest 30-second rolling average value recorded prior to test termination.
Measured: Baseline (Day 1-CPET) and IST assessments at Visits 2 and 3, scheduled at 3-7-day intervals.
Secondary outcomes (2)
Test-retest reliability of oxygen uptake at Anaerobic Threshold (AT)
Test-retest reliability of oxygen uptake at AT (mL/min) derived from the Incremental Step Test (IST) between the first and second IST visits.
Measured: (Day 3-IST Visit 2) and IST Visit 3, scheduled 3-7 days apart.
Test-retest reliability of oxygen uptake at Respiratory compensation point (RCP)
Test-retest reliability of oxygen uptake at RCP (mL/min) derived from the Incremental Step Test (IST) between the first and second IST visits.
Measured: (Day 3-IST Visit 2) and IST Visit 3, scheduled 3-7 days apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start20 Jul 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorespiratory FitnessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-group diagnostic validation and test-retest reliability study evaluating a novel Incremental Step Test against an established laboratory-based cycle ergometer Cardiopulmonary Exercise Test comparator.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heriot-Watt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David King, Heriot-Watt University
- Investigators
- David King, BSc, MSc, PhD, Principal investigator, Heriot-Watt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829003
- Sponsor's protocol ID
- Ref: 2025-12928-16897
- Acronym
- VALID-IST
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared publicly. The study will report findings using aggregated and de-identified data. Individual participant data will be retained securely by the research team in accordance with Heriot-Watt University research governance and data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel Incremental Step Test for Assessment of Cardiopulmonary Fitness and Ventilatory Thresholds in Adults
- ClinicalTrials.gov ID
- NCT07829003
- Acronym / sponsor ID
- VALID-IST / Ref: 2025-12928-16897
- Conditions
- Cardiorespiratory Fitness, Metabolic Health, Cardiac Function, Pulmonary Function, Exercise Test
- Keywords
- Cardiopulmonary Exercise Testing, CPET, Exercise testing, Incremental Step Test, VO2 peak, Ventilatory threshold, reliability, validation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Heriot-Watt UniversityUniversity, hospital or other
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 18 Sep 2026 (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 single-group diagnostic validation and test-retest reliability study is to determine whether a novel Incremental Step Test (IST) can accurately assess cardiorespiratory fitness and ventilatory thresholds in healthy adults compared with an established laboratory-based cycle ergometer Cardiopulmonary Exercise Test (CPET). The main questions are whether the step test can elicit reliable physiological responses sufficient to identify the anaerobic threshold and respiratory compensation point, and whether it produces reproducible results when repeated under standardised conditions. The study will compare the incremental step test (IST) with CPET to assess whether the IST provides similar peak and submaximal physiological measures and agreement with CPET comparator. Participants will complete three laboratory exercise tests across separate visits: one maximal CPET on a cycle ergometer, followed by two repeated ISTs performed on a 25 cm step board following the audio metronome.
Detailed description
Participants will attend three laboratory visits separated by at least 3 days and conducted at similar times of the day. The first visit will include screening, anthropometric assessment, and a maximal CPET on an electronically braked cycle ergometer using a ramp protocol of 25 W/min for males and 20 W/min for females. Participants will complete 3 minutes of unloaded cycling followed by incremental protocol while maintaining the cadence at least 60 rpm, and the test will be terminated if they can no longer can sustain this cadence. Following CPET, participants will complete a 6-minute familiarisation session to practise the stepping activity, including the up-up-down-down stepping technique and alternation of the leading leg every 2 minutes. The second and third visits will involve repeated IST trials performed on 25 cm step board, with cadence progressed from 20 beats per minute and increased by 4 beats per minute every 20 seconds until volitional exhaustion. The IST will be terminated if the participant is unable to maintain the prescribed stepping rhythm for more than 15 seconds. Continuous breath-by-breath gas exchange, ECG, and heart rate monitoring will be used during testing to characterise peak performance and ventilatory threshold responses. Agreement between the step test and CPET, as well as test-retest reproducibility of the IST, will be evaluated to determine whether the new protocol could support more individualised exercise prescription in stepping-based activities.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-group diagnostic validation and test-retest reliability study evaluating a novel Incremental Step Test against an established laboratory-based cycle ergometer Cardiopulmonary Exercise Test comparator.
| Arm | Type | Receives |
|---|---|---|
| Incremental Step Test Validation Protocol | Experimental | Diagnostic Test: Cardiopulmonary Exercise Test, Diagnostic Test: Incremental Step TestParticipants will complete one laboratory-based Cardiopulmonary Exercise Test followed by two Incremental Step Test sessions conducted on separate visits. The first visit will include screening, anthropometric measurements, and a maximal incremental CPET on an electronically braked cycle ergometer using an individualised ramp protocol set at 25 W/min for males and 20 W/min for females, after 3 minutes of unloaded cycling. The second and third visits will involve two repeated incremental step tests on a standardised 25 cm step, with cadence starting at 20 beats per minute and increasing by 4 beats per minute every 20 seconds until volitional exhaustion. The CPET will be terminated if participants could not maintain a cadence of at least 60 rpm, and the step test will be terminated if participants could not maintain the prescribed stepping rhythm for 15 consecutive seconds. Exercise ECG, continuous heart rate, and breath-by-breath gas exchange will be recorded during all exercise tests. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adults aged 18 to 55 years.
- Body mass index between 18.5 and 29.9 kg/m².
- Non-smoker.
- No known cardiovascular, respiratory, metabolic, neurological, or musculoskeletal conditions that would contraindicate maximal exercise testing.
- Able to provide written informed consent.
Key exclusion criteria (11 listed)
- Age younger than 18 years or older than 55 years.
- Body mass index below 18.5 kg/m² or above 29.9 kg/m².
- Current smoker or use of nicotine products.
- Known cardiovascular, respiratory, metabolic, neurological, or musculoskeletal conditions that may affect exercise performance or make maximal exercise testing unsafe.
- Any contraindication to maximal exercise testing according to established exercise testing guidelines.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary Exercise TestA maximal incremental exercise test performed on a cycle ergometer with continuous breath-by-breath gas exchange and heart rate monitoring to assess cardiorespiratory fitness and physiological response | Diagnostic test | Incremental Step Test Validation Protocol |
| Incremental Step TestA progressive step test using a standardised 25 cm step platform. Participants will complete a 3-minute warm-up at 20 beats per minute before cadence increases by 4 beats per minute every 20 seconds until volitional exhaustion or predefined termination criteria are reached. | Diagnostic test | Incremental Step Test Validation Protocol |
Primary outcome
Between-method agreement in oxygen uptake at Anaerobic Threshold (AT)
Time frame: Baseline (Day 1-CPET) and IST assessments at Visits 2 and 3, scheduled at 3-7-day intervals.
Agreement between the Incremental Step Test and the established laboratory-based cycle ergometer Cardiopulmonary Exercise Test comparator for oxygen uptake at Anaerobic Threshold (mL/min), will be assessed using intraclass correlation coefficients and Bland-Altman analysis.
Between-method agreement in oxygen uptake at Respiratory Compensation Point (RCP)
Time frame: Baseline (Day 1-CPET) and IST assessments at Visits 2 and 3, scheduled at 3-7-day intervals.
Agreement between the Incremental Step Test and the established laboratory-based cycle ergometer Cardiopulmonary Exercise Test comparator for oxygen uptake at Respiratory Compensation point / Ventilatory Threshold 2 (mL/min), will be assessed using intraclass correlation coefficients and Bland-Altman analysis.
Between-method agreement in Peak Oxygen Uptake (VO2peak)
Time frame: Baseline (Day 1-CPET) and IST assessments at Visits 2 and 3, scheduled at 3-7-day intervals.
Peak oxygen uptake will be defined as the highest 30-second rolling average value recorded prior to test termination.
2 secondary outcomes
Test-retest reliability of oxygen uptake at Anaerobic Threshold (AT)
Time frame: (Day 3-IST Visit 2) and IST Visit 3, scheduled 3-7 days apart.
Test-retest reliability of oxygen uptake at Respiratory compensation point (RCP)
Time frame: (Day 3-IST Visit 2) and IST Visit 3, scheduled 3-7 days apart.
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 18 Sep 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared publicly. The study will report findings using aggregated and de-identified data. Individual participant data will be retained securely by the research team in accordance with Heriot-Watt University research governance and data protection requirements.
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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.
David King, BSc, MSc, PhD principal investigator
Heriot-Watt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiopulmonary Exercise Test and Incremental Step Test in people with Cardiorespiratory Fitness and Metabolic Health, run by Heriot-Watt University at 1 site in United Kingdom.
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 6 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 18 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 1 site in United Kingdom. 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?
Between-method agreement in oxygen uptake at Anaerobic Threshold (AT) (time frame: Baseline (Day 1-CPET) and IST assessments at Visits 2 and 3, scheduled at 3-7-day intervals.). 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 18 Sep 2026.