- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07718594
Modality-Specific Heart Rate Differences at Ventilatory Thresholds During Unified Ramp Testing
Evaluation of Heart Rate and Ventilatory Threshold Agreement Between Cycling and Running Under Strictly Standardized Ramp Conditions
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Taipei City
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Taipei, Taipei City, Tchaj-wan, 10630
- Cathay General Hospitla
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age ≥ 20 years.
- Familiarity with both cycling and treadmill exercise.
- Negative response on the Physical Activity Readiness Questionnaire (PAR-Q).
Exclusion Criteria:
- History of cardiovascular, pulmonary, or metabolic disease.
- Musculoskeletal injuries limiting exercise range of motion.
- Use of medications known to affect heart rate or ventilation.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Cycling-First Sequence
Participants 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.
|
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.
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.
|
|
Experimentální: Treadmill-First Sequence
Participants 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.
|
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.
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Modality-Specific Heart Rate Differences at Ventilatory Thresholds (VT1 and VT2)
Časové okno: Identified during each 8 to 12-minute cardiopulmonary exercise test session (Sessions separated by 7 to 14 days).
|
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.
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Identified during each 8 to 12-minute cardiopulmonary exercise test session (Sessions separated by 7 to 14 days).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Oxygen Consumption (VO2) at Thresholds and Peak
Časové okno: Extracted as 30-second averages centered on the threshold time points and peak during each exercise test session.
|
Absolute and relative oxygen consumption (mL/kg/min) at VT1, VT2, and peak exercise.
|
Extracted as 30-second averages centered on the threshold time points and peak during each exercise test session.
|
|
Ventilatory Equivalent for Carbon Dioxide (EqCO2)
Časové okno: immediately after exercise test
|
VE/VCO2 ratio at VT1 and VT2 to assess cross-modal reliability.
|
immediately after exercise test
|
|
Oxygen Pulse (O2 pulse)
Časové okno: immediately after exercise test
|
Calculated as VO2 divided by heart rate (mL/beat) at VT1 and VT2 to evaluate stroke volume and tissue extraction markers across modalities.
|
immediately after exercise test
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 202311036RIND
Plán pro data jednotlivých účastníků (IPD)
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Typ podpůrných informací pro sdílení IPD
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- MÍZA
- ANALYTIC_CODE
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