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临床试验/NCT07718594
NCT07718594已完成不适用

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

Cathay General Hospital1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Modality-Specific Heart Rate Differences at Ventilatory Thresholds (VT1 and VT2)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

Blinded, experienced raters

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Oxygen Consumption (VO2) at Thresholds and Peak(Extracted as 30-second averages centered on the threshold time points and peak during each exercise test session.)
  • Ventilatory Equivalent for Carbon Dioxide (EqCO2)(immediately after exercise test)
  • Oxygen Pulse (O2 pulse)(immediately after exercise test)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tung-Chou Li

visiting staff

Cathay General Hospital

研究点 (1)

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