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Exercise PhysiologyNCT07718594

Modality-Specific Heart Rate Differences at Ventilatory Thresholds During Unified Ramp Testing

A study testing Cycle Ergometer CPET and Motorized Treadmill CPET (Porszász Protocol) in people with Exercise Physiology and Ventilatory Threshold, run by Cathay General Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to investigate the heart rate bias between cycling and treadmill exercise at ventilatory thresholds. This was a randomized crossover trial involving 23 healthy participants. Each participant performed both cycling and treadmill exercise tests in a randomized order. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
What is being tested?
Cycle Ergometer CPET and Motorized Treadmill CPET (Porszász Protocol)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteTaiwan
Study dates
1 Feb 2024to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥ 20 years.
  • Familiarity with both cycling and treadmill exercise.
  • Negative response on the Physical Activity Readiness Questionnaire (PAR-Q).

Who cannot join

  • History of cardiovascular, pulmonary, or metabolic disease.
  • Musculoskeletal injuries limiting exercise range of motion.
  • Use of medications known to affect heart rate or ventilation.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Cathay General Hospitla

    Taipei, Taipei City, 10630

Other trials in Taiwan

About this study

Official title: Evaluation of Heart Rate and Ventilatory Threshold Agreement Between Cycling and Running Under Strictly Standardized Ramp Conditions

The purpose of this study was to investigate the heart rate bias between cycling and treadmill exercise at ventilatory thresholds. This was a randomized crossover trial involving 23 healthy participants. Each participant performed both cycling and treadmill exercise tests in a randomized order. The primary outcome was to determine the difference in heart rate response at the first and second ventilatory thresholds between the two exercise modalities. We hypothesized that there is a fixed bias in heart rate response, which may have implications for exercise prescription in clinical and rehabilitation settings.

Read the detailed description

Participants Twenty-three healthy adults (12 men, 11 women; age 30.8 ± 5.6 years; BMI 21.8 ± 2.6 kg/m²) were recruited via institutional advertisements at a university hospital. Inclusion criteria were: age ≥ 20 years, familiarity with cycling and treadmill exercise, and a negative Physical Activity Readiness Questionnaire response. Exclusion criteria were: history of cardiovascular, pulmonary, or metabolic disease; musculoskeletal injuries limiting exercise range of motion; or medications affecting heart rate or ventilation. Participants fasted for 3 hours, abstained from vigorous exercise, alcohol, and caffeine for 24 hours prior to testing, and provided written informed consent. Data collection was conducted between February 2024 and November 2024. The protocol was approved by the Institutional Review Board of National Taiwan University Hospital (IRB Registration: 202311036RIND).

Experimental Design A randomized crossover design was employed. Participants completed two symptom-limited CPET sessions on a cycle ergometer (VIAsprint, Ergoline, Germany) and motorized treadmill (Ergosprint, Ergoline, Germany), separated by 7-14 days and conducted at the same time of day (±2 hours) to control for circadian effects. The randomized order minimized potential order effects and ensured that fatigue from the first test did not systematically bias results.

Cardiopulmonary Exercise Testing Protocol Gas Exchange Measurement and Safety Monitoring Breath-by-breath gas exchange was measured using a metabolic cart (Vmax Encore, CareFusion, USA), calibrated before each test with standard gases and a 3-L calibration syringe. Heart rate was monitored continuously via 12-lead electrocardiography (Cardiosoft, GE Healthcare, USA), providing greater temporal resolution than telemetric methods. Blood pressure was measured at rest and every 2 minutes during exercise to monitor safety and detect cardiovascular abnormalities.

Unified Ramp Protocol The central innovation was implementing a unified ramp protocol on both modalities to eliminate kinetic confounding.

Cycle Ergometer: Following a 3-minute unloaded warm-up (0 W), continuous ramp increases began at 20 W·min-¹ (men) or 15 W·min-¹ (women), targeting an 8-12 minute test duration to optimize threshold identification within a physiologically relevant window.

Treadmill: Using the Porszász algorithm, simultaneous adjustments to speed and grade produced metabolically equivalent work rate increases (20 or 15 W·min-¹), matched to cycling. Warm-up consisted of 3 minutes at 3-4 km/h, 0% grade. The Porszász protocol mathematically calculates the non-linear combination of speed and grade increases needed to produce a linear rise in metabolic demand, ensuring identical oxygen uptake kinetic demands despite different biomechanical constraints.

Maximal Effort Verification Participants exercised to volitional exhaustion or until safety criteria were met. Maximal effort was confirmed by meeting ≥2 of the following criteria: respiratory exchange ratio (RER) ≥ 1.10; heart rate within 10 bpm of age-predicted maximum (220 - age); rating of perceived exertion (RPE) ≥ 17 on the Borg 6-20 scale; or VO₂ plateau (≤150 mL·min-¹ increase despite increasing workload).

Threshold Determination Breath-by-breath gas exchange data were binned into 5-second moving averages to attenuate noise while preserving dynamic resolution at the threshold transition point. VT1 and VT2 were identified independently by two blinded, experienced raters using consensus criteria (V-slope method, ventilatory equivalents, end-tidal gas tensions). Blinding was maintained by removing all identifiers before threshold determination. Disagreements (2 cases) were adjudicated by a third blinded expert. Inter-rater reliability was excellent (ICC = 0.94 for VT1; ICC = 0.96 for VT2). Variables were extracted as 30-second averages centered on the identified threshold time point to ensure stability.

Statistical Analysis Primary and Secondary Outcomes Primary outcome: heart rate difference at VT1 and VT2 between modalities. Secondary outcomes: absolute and relative VO₂, EqO₂, EqCO₂, and O₂ pulse.

Data Analysis Methods Data normality was assessed using the Shapiro-Wilk test. Paired t-tests compared variables between modalities, with two-tailed significance testing at α = 0.05. Intraclass correlation coefficients (ICC; two-way mixed-effects, absolute agreement) assessed measurement reliability. Measurement error was quantified using the coefficient of variation (CV = SD of differences/mean), which normalizes variability to enable comparison across variables with different scales.

Bland-Altman Regression Analysis for Proportional Bias Bland-Altman analysis with linear regression tested for fixed versus proportional bias-the core statistical innovation distinguishing this study. The difference between modalities (Cycling - Treadmill) was regressed against the mean of the two measurements. A non-significant regression slope (p > 0.05) indicated fixed bias, whereas a significant slope (p < 0.05) indicated proportional bias. This approach directly tests whether correction factors should be constant across participants or adjusted based on individual physiological capacity.

All statistical analyses were performed using SPSS Statistics Version 20 (IBM Corp., Armonk, NY) for ICC and t-tests, and GraphPad Prism Version 10 (GraphPad Software, San Diego, CA) for Bland-Altman plots.

Being tested
Cycle Ergometer CPET, Motorized Treadmill CPET (Porszász Protocol)
Keywords
Randomized Crossover Trial, Exercise Intensity, Cardiorespiratory Fitness, Ventilatory Thresholds, Heart Rate
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cycle Ergometer CPETDevice

    Following a 3-minute unloaded warm-up (0 W), continuous ramp increases began at 20 W/min for men or 15 W/min for women, targeting an 8-12 minute test duration to volitional exhaustion.

  • Motorized Treadmill CPET (Porszász Protocol)Device

    Standardized ramp testing utilizing the Porszász algorithm. Simultaneous adjustments to speed and grade mathematically produce a linear rise in metabolic demand (matched to 20 or 15 W/min based on sex), ensuring identical oxygen uptake kinetic demands to the cycling protocol.

Study groups in NCT07718594
Study groupRoleWhat they receive
Cycling-First SequenceExperimentalParticipants in this arm are randomized to perform the continuous ramp cardiopulmonary exercise testing (CPET) on a cycle ergometer first. After a washout period of 7 to 14 days, they cross over to perform the standardized treadmill ramp testing.
Receives: Device: Cycle Ergometer CPET; Device: Motorized Treadmill CPET (Porszász Protocol)
Treadmill-First SequenceExperimentalParticipants in this arm are randomized to perform the standardized treadmill ramp cardiopulmonary exercise testing (CPET) using the Porszász algorithm first. After a washout period of 7 to 14 days, they cross over to perform the cycle ergometer ramp testing.
Receives: Device: Cycle Ergometer CPET; Device: Motorized Treadmill CPET (Porszász Protocol)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modality-Specific Heart Rate Differences at Ventilatory Thresholds (VT1 and VT2)

    The absolute difference in heart rate (measured in beats per minute, bpm) recorded at the first ventilatory threshold (VT1) and second ventilatory threshold (VT2) between cycle ergometry and treadmill running.

    Measured: Identified during each 8 to 12-minute cardiopulmonary exercise test session (Sessions separated by 7 to 14 days).

Secondary outcomes (3)
  1. Oxygen Consumption (VO2) at Thresholds and Peak

    Absolute and relative oxygen consumption (mL/kg/min) at VT1, VT2, and peak exercise.

    Measured: Extracted as 30-second averages centered on the threshold time points and peak during each exercise test session.

  2. Ventilatory Equivalent for Carbon Dioxide (EqCO2)

    VE/VCO2 ratio at VT1 and VT2 to assess cross-modal reliability.

    Measured: immediately after exercise test

  3. Oxygen Pulse (O2 pulse)

    Calculated as VO2 divided by heart rate (mL/beat) at VT1 and VT2 to evaluate stroke volume and tissue extraction markers across modalities.

    Measured: immediately after exercise test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2026
  2. Study start1 Feb 2024
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07718594
Sponsor's protocol ID
202311036RIND
Status last verified
Jul 2026
First submitted
14 Jul 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The de-identified individual participant data that underlie the results reported in this article will be available to other researchers who provide a methodologically sound proposal. Proposals may be submitted to the corresponding author twdoggy@yahoo.com.tw for review. Data access will be granted upon signature of a data access agreement and ethical approval.

Questions about this trial

What is this clinical trial studying?

A study testing Cycle Ergometer CPET and Motorized Treadmill CPET (Porszász Protocol) in people with Exercise Physiology and Ventilatory Threshold, run by Cathay General Hospital at 1 site in Taiwan.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jul 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 Taiwan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Modality-Specific Heart Rate Differences at Ventilatory Thresholds (VT1 and VT2) (time frame: Identified during each 8 to 12-minute cardiopulmonary exercise test session (Sessions separated by 7 to 14 days).). 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 22 Jul 2026.

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