Comparison of Pulse Wave and Blood Pressure Measurements Before, During and After Ergometry in Healthy Men
- Conditions
- Healthy Male Subjects
- Registration Number
- NCT03790722
- Lead Sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Difference of the systolic blood pressure 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
- Secondary Outcome Measures
Name Time Method 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 Diastolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
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 Tmax-forward (s) measured with the Mobil-O-Graph® PWA device
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 Mean Arterial Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
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 Pulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device
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 Systolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
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 Pulse Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
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 Reflection Coefficient (%) measured with the Mobil-O-Graph® PWA device
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 Diastolic Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
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 Pulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
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 Oxygen saturation (% SpO2) measured with the SOMNOtouchTM RESP device
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 Stroke Volume (ml) measured with the Mobil-O-Graph® PWA device
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 Vascular Resistance (s\*mmHg/ml) measured with the Mobil-O-Graph® PWA device
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 Cardiac Index (l/min\*1/m2) measured with the Mobil-O-Graph® PWA device
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 Augmentation Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
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 Systole Time (s) measured with the Mobil-O-Graph® PWA device
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 Pulse Transit Time (PTT, ms) measured with the GeTeMed Vitaguard 3100 device
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 Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100 device
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 SlopeInW2 measured with the GeTeMed Vitaguard 3100 device
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 Heartrate (beats per minute, bpm) measured with the SOMNOtouchTM RESP device
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 Mean Arterial Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
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 Heartrate (beats per minute, bpm) measured with the Mobil-O-Graph® PWA device
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 Puls Pressure Amplification measured with the Mobil-O-Graph® PWA device
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 Cardiac output (l/min) measured with the Mobil-O-Graph® PWA device
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 Pulse Wave Velocity (PWV, m/s) measured with the Mobil-O-Graph® PWA device
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 Tmax-backward (s) measured with the Mobil-O-Graph® PWA device
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 Perfusion Index (PI) measured with the GeTeMed Vitaguard 3100 device
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 Forward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
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 Backward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
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 SlopeInW1 measured with the GeTeMed Vitaguard 3100 device
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 SlopeInW3 measured with the GeTeMed Vitaguard 3100 device
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 SlopeInW4 measured with the GeTeMed Vitaguard 3100 device
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 StiffnessIndex measured with the GeTeMed Vitaguard 3100 device
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 ReflectionIndex measured with the GeTeMed Vitaguard 3100 device
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 TimeTX (ms) measured with the GeTeMed Vitaguard 3100 device
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 QuotAYAX measured with the GeTeMed Vitaguard 3100 device
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 AreaAV measured with the GeTeMed Vitaguard 3100 device
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 AreaAW measured with the GeTeMed Vitaguard 3100 device
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 TimeTV (ms) measured with the GeTeMed Vitaguard 3100 device
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 TimeTW (ms) measured with the GeTeMed Vitaguard 3100 device
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 TimeTY (ms) measured with the GeTeMed Vitaguard 3100 device
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 AreaAX measured with the GeTeMed Vitaguard 3100 device
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 Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak
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 Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 device
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 QuotTYTX measured with the GeTeMed Vitaguard 3100 device
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 AreaAY measured with the GeTeMed Vitaguard 3100 device
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 QuotAWAV measured with the GeTeMed Vitaguard 3100 device
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 QuotTVTW measured with the GeTeMed Vitaguard 3100 device
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 Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the first peak
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 Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the first peak
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 Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the second peak
Trial Locations
- Locations (1)
ARCIM Institute
🇩🇪Filderstadt, Baden Württemberg, Germany
ARCIM Institute🇩🇪Filderstadt, Baden Württemberg, Germany