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Enrolling by invitation

NCT Number: NCT07829003

Validation of a Novel Incremental Step Test for Assessment of Cardiopulmonary Fitness and Ventilatory Thresholds in Adults

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.

Enrolling by invitation

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oriam Scotlant Performance Centre

Edinburgh, EH14 4AS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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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Treatment and study plan

cardiopulmonary exercise test

Diagnostic 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 Test

Diagnostic 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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 AT (mL/min) derived from the Incremental Step Test (IST) between the first and second IST visits.

  2. 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.

    Test-retest reliability of oxygen uptake at RCP (mL/min) derived from the Incremental Step Test (IST) between the first and second IST visits.

Sponsors and collaborators

Lead sponsor

Heriot-Watt University

Other

Registry information

Acronym: VALID-IST

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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