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Validation of a Novel Incremental Step Test for Assessment of Cardiopulmonary Fitness and Ventilatory Thresholds in Adults (VALID-IST)

14 settembre 2026 aggiornato da: David King, Heriot-Watt University
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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
      • Edinburgh, Regno Unito, EH14 4AS
        • Oriam Scotlant Performance Centre

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  1. Healthy adults aged 18 to 55 years.
  2. Body mass index between 18.5 and 29.9 kg/m².
  3. Non-smoker.
  4. No known cardiovascular, respiratory, metabolic, neurological, or musculoskeletal conditions that would contraindicate maximal exercise testing.
  5. Able to provide written informed consent.
  6. Willing and able to complete one Cardiopulmonary Exercise Test and two Incremental Step Test sessions.

Exclusion Criteria:

  1. Age younger than 18 years or older than 55 years.
  2. Body mass index below 18.5 kg/m² or above 29.9 kg/m².
  3. Current smoker or use of nicotine products.
  4. Known cardiovascular, respiratory, metabolic, neurological, or musculoskeletal conditions that may affect exercise performance or make maximal exercise testing unsafe.
  5. Any contraindication to maximal exercise testing according to established exercise testing guidelines.
  6. Use of medications known to significantly affect cardiovascular, respiratory, or metabolic responses to exercise.
  7. Current injury, illness, or infection that may limit participation in exercise testing.
  8. Pregnancy.
  9. Inability to provide informed consent.

  10. Inability to complete study procedures or attend all required study visits.

    -

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Incremental Step Test Validation Protocol
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.
Test diagnostico: Cardiopulmonary Exercise 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
Test diagnostico: Incremental Step 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Between-method agreement in oxygen uptake at Anaerobic Threshold (AT)
Lasso di tempo: 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.
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)
Lasso di tempo: 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.
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)
Lasso di tempo: 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.
Baseline (Day 1-CPET) and IST assessments at Visits 2 and 3, scheduled at 3-7-day intervals.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Test-retest reliability of oxygen uptake at Anaerobic Threshold (AT)
Lasso di tempo: (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.
(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)
Lasso di tempo: (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.
(Day 3-IST Visit 2) and IST Visit 3, scheduled 3-7 days apart.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Heriot-Watt University

Investigatori

  • Investigatore principale: David King, BSc, MSc, PhD, Heriot-Watt University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 luglio 2026

Completamento primario (Stimato)

30 settembre 2026

Completamento dello studio (Stimato)

30 ottobre 2026

Date di iscrizione allo studio

Primo inviato

8 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 settembre 2026

Primo Inserito (Effettivo)

18 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Ref: 2025-12928-16897

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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