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临床试验/NCT03790722
NCT03790722已完成不适用

Comparison of Pulse Wave and Blood Pressure Parameters Before, During and After Exercise Ergometry in Healthy Male Subjects - a Randomized, Controlled, Single-blind Study

ARCIM Institute Academic Research in Complementary and Integrative Medicine2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月28日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Difference of the systolic blood pressure
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this randomized, controlled single blind study is to compare pulse wave and blood pressure measurements before, during and after exercise ergometry in healthy male subjects.

详细描述

In a randomized single-blind study design the investigators explore how well blood pressure parameters calculated using a Pulse Transit Time-based method (device: SOMNOtouchTM RESP) match blood pressure parameters measured by a classic upper arm blood pressure cuff (Mobil-O-Graph® PWA) under standardized load conditions (ergometry).

In 30 healthy male subjects (age 18 - 40 years), cardiovascular parameters before, during and after a standardized load on a bicycle ergometer (half-lying position) are recorded with three different devices (Mobil-O-Graph® PWA versus SOMNOtouchTM RESP versus GeTeMed Vitaguard 3100) and compared.

Primary outcome is the difference of the systolic blood pressure values between the devices Mobil-O-Graph® PWA versus SOMNOtouchTM RESP during the three phases.

The Mobil-O-Graph® PWA blood pressure cuff is applied randomized to the arm with the previously determined higher or lower systolic blood pressure mean difference. The subjects are blinded to the results of the measurements during ergometry.

After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest period. Measurements are taken every two minutes with the Mobil-O-Graph® PWA; data acquisition with the SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 devices takes place continuously over a total duration of 72 minutes.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years（Adult）
性别
Male
接受健康志愿者
是

入选标准

  • •Signed informed consent
  • •Healthy at the time of the examinations
  • •Inconspicuous anamnesis regarding cardiovascular diseases and bronchial asthma
  • •resting heart rate 50 to 100 beats per minute
  • •Normal blood pressure or appropriately treated and controlled hypertension (systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg)

排除标准

  • •Acute or chronic (especially cardiovascular) diseases, including cardiac arrhythmia and vegetative regulatory disorders (recorded via anamnesis)
  • •Taking allopathic medication: digitalis, beta blockers, antiarrhythmics
  • •Bronchial asthma (recorded by anamnesis)
  • •Alcohol abuse
  • •Heart diseases NYHA class IV
  • •Blood pressure side difference ≥ 10mmHg
  • •Fever (> 37,5°C)

研究组 & 干预措施

Higher Blood Pressure

Experimental

Mobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure. Intervention: Ergometry H

干预措施: Ergometry H (Other)

Lower Blood Pressure

Experimental

Mobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure. Intervention: Ergometry L

干预措施: Ergometry L (Other)

结局指标

主要结局

Difference of the systolic blood pressure

时间窗: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

Primary outcome is the difference of the systolic blood pressure values between the devices Mobil-O-Graph® PWA versus SOMNOtouchTM RESP during the three phases

次要结局

  • Diastolic Blood Pressure measured with the device Mobil-O-Graph® PWA(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Tmax-forward (Mobil-O-Graph® PWA)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Mean Arterial Blood Pressure (SOMNOtouchTM RESP)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Pulse-Transit-Time (PTT, SOMNOtouchTM RESP)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Systolic Blood Pressure measured with the device Mobil-O-Graph® PWA(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Pulse Pressure measured with the device Mobil-O-Graph® PWA(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Reflection Coefficient (Mobil-O-Graph® PWA)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Diastolic Blood Pressure (SOMNOtouchTM RESP)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Pulse Pressure (SOMNOtouchTM RESP)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Oxygen saturation (SpO2, SOMNOtouchTM RESP)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Stroke Volume (Mobil-O-Graph® PWA)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Vascular Resistance (Mobil-O-Graph® PWA)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Cardiac Index (Mobil-O-Graph® PWA)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Augmentation Pressure (Mobil-O-Graph® PWA)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Systole Time (Mobil-O-Graph® PWA)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Pulse Transit Time (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Peak to Peak Time (PPT) (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • SlopeInW2 (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Heartrate (SOMNOtouchTM RESP)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Mean Arterial Blood Pressure measured with the device Mobil-O-Graph® PWA(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Heartrate (Mobil-O-Graph® PWA)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Puls Pressure Amplification (Mobil-O-Graph® PWA)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Cardiac output (Mobil-O-Graph® PWA)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Pulse Wave Velocity (PWV) (Mobil-O-Graph® PWA)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Tmax-backward (Mobil-O-Graph® PWA)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Perfusion Index (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Forward Pressure (Mobil-O-Graph® PWA)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • Backward Pressure (Mobil-O-Graph® PWA)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • SlopeInW1 (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • SlopeInW3 (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • SlopeInW4 (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • StiffnessIndex (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • ReflectionIndex (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • TimeTX (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • QuotAYAX (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • AreaAV (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • AreaAW (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • TimeTV (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • TimeTW (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • TimeTY (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • AreaAX (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • MinT2 (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • QuotHRRespRate (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • QuotTYTX (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • AreaAY (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • QuotAWAV (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • QuotTVTW (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • MinT1 (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • MaxT1 (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)
  • MaxT2 (GeTeMed Vitaguard 3100)(Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min)

研究者

发起方
ARCIM Institute Academic Research in Complementary and Integrative Medicine
申办方类型
Other
责任方
Sponsor

研究点 (2)

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