Effects of Physical Exercise (Bicycle Ergometer) on Peripheral Hemodynamics in Healthy Adult Male Volunteers: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Perfusion Index (PI) during and after Standardized Bicycle Ergometer Exercise
研究概览
简要总结
This study examines how cycling on an exercise bicycle affects blood flow and heart and circulation in 12 healthy adult men. The main measurement is the perfusion index, which indicates how well blood is flowing through the small blood vessels. The study also measures pulse waves, blood pressure, the time it takes for the pulse wave to travel through the body, changes in heart rate, and the relationship between pulse and breathing. In addition, two pulse oximeter systems, Masimo and Nellcor, are compared, as well as measurements taken from the forehead and the finger.
详细描述
This single-center clinical study investigates the effects of standardized physical exercise on a bicycle ergometer on the perfusion index (PI) and other cardiovascular parameters. In 12 healthy adult male participants (age 20 - 40 years) cardiovascular parameters before, during and after a single standardized bicycle ergometer exercise test (half-lying position) are recorded with different devices (GeTeMed Vitaguard 3100; Masimo Radical-7; Nellcor N-600; Micro Medical PulseTrace PWV; Schiller MT300 Light-Holter-BPR; TOM Medical Single-lead ECG) and compared. In addition, two pulse oximeters will be compared (Masimo versus Nellcor), as well as the measurement quality of forehead and finger sensors. After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 28 minutes, followed by a 16-minute rest period. It is hypothesized that the PI will increase during exercise and subsequently decrease during the recovery phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Written informed consent for participation in the study
- •Non-smoker
- •Normal resting electrocardiogram and resting blood pressure not exceeding 140/90 mmHg
- •No family history of myocardial infarction or sudden cardiac death in a first-degree relative younger than 60 years at the time of the event
排除标准
- •Acute or chronic diseases, particularly cardiovascular conditions
- •Use of conventional medications or recreational drugs
- •Disorders of autonomic regulation
研究组 & 干预措施
Standardized Bicycle Ergometer Exercise
Healthy male participants aged 20 to 40 years undergo a single standardized bicycle ergometer exercise test in a semi-recumbent position. Following a 12-minute pre-exercise resting period, participants perform 28 minutes of graded bicycle ergometer exercise at exercise intensities ranging from 30% to 90% of their individual maximum exercise capacity. The exercise period is followed by a 16-minute post-exercise recovery period. Cardiovascular, hemodynamic, heart rate variability, photoplethysmographic, and pulse oximetry parameters are recorded before, during, and after exercise using multiple measurement devices.
干预措施: Standardized Bicycle Ergometer Exercise (Behavioral)
结局指标
主要结局
Change in Perfusion Index (PI) during and after Standardized Bicycle Ergometer Exercise
时间窗: Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes
The perfusion index (PI) will be continuously recorded using the VitaGuard 3100 (Getemed, Teltow, Germany) at a sampling rate of 1 Hz. PI values will be averaged over 1-minute intervals. Within-participant changes in PI will be assessed across the pre-exercise resting phase, graded bicycle ergometer exercise at 30% to 90% of the participant's individual maximum exercise capacity, and the post-exercise recovery phase.
次要结局
- Change in Standard Deviation of Normal-to-Normal Intervals (SDNN)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes)
- Change in Root Mean Square of Successive Differences (RMSSD)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes)
- Change in Relative Very-Low-Frequency Heart Rate Variability Power (VLF%)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes)
- Change in Relative High-Frequency Heart Rate Variability Power (HF%)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes)
- Change in Low-Frequency to High-Frequency Power Ratio (LF/HF Ratio)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes)
- Change in Pulse Transit Time (PTT)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes)
- Change in Peripheral Systolic Blood Pressure(Baseline, every 2 minutes during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes)
- Change in Peripheral Diastolic Blood Pressure(Baseline, every 2 minutes during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes)
- Change in Pulse-to-Respiration Ratio(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes)
- Change in Photoplethysmographic Stiffness Index (SI)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes)
- Change in Photoplethysmographic Reflection Index (RI)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes)
- Change in Pleth Variability Index (PVI)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes)
- Difference in Peripheral Oxygen Saturation Between Forehead and Finger Sensor Locations(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes)
- Difference in Peripheral Oxygen Saturation Between Masimo and Nellcor Pulse Oximetry Systems(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes)
- Change in Mean Normal-to-Normal Interval (Mean NN)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes.)
- Change in Percentage of Successive NN Intervals Differing by More Than 50 ms (pNN50)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes.)
- Change in Total Heart Rate Variability Power(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes.)
- Change in Ultra-Low-Frequency Heart Rate Variability Power (ULF Power)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes.)
- Change in Very-Low-Frequency Heart Rate Variability Power (VLF Power)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes.)
- Change in Low-Frequency Heart Rate Variability Power (LF Power)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes.)
- Change in High-Frequency Heart Rate Variability Power (HF Power)(Baseline (12-minute pre-exercise rest), during 28 minutes of bicycle ergometer exercise, and during 16 minutes of post-exercise recovery; total assessment duration: 56 minutes.)