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

NCT07829003 | Enrolling By Invitation DMC

• 1 other identifier: Ref: 2025-12928-16897
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Metabolic Health; Pulmonary Function; Cardiac Function; Exercise Test; Cardiorespiratory Fitness

Keywords

Cardiopulmonary Exercise Testing; CPET; Exercise testing; Incremental Step Test; VO2 peak; Ventilatory threshold; reliability; validation; gas exchange; anaerobic threshold

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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)

  (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)

  (Day 3-IST Visit 2) and IST Visit 3, scheduled 3-7 days apart.

Study Arms (1)

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.

Diagnostic Test: Cardiopulmonary Exercise Test; Diagnostic Test: Incremental Step Test

Interventions

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 Validation Protocol

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.

Incremental Step Test Validation Protocol

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heriot-Watt University: lead

Study Sites (1)

Oriam Scotlant Performance Centre

Edinburgh, EH14 4AS, United Kingdom

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• David King, BSc, MSc, PhD

  Heriot-Watt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 18, 2026
• Study Start: July 20, 2026
• Primary Completion: September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)