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NCT03790722 Clinical Trial

Comparison of Pulse Wave and Blood Pressure Measurements Before, During and After Ergometry in Healthy Men

Healthy Male Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03790722
Other study ID # ERG_02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 28, 2019
Est. completion date May 22, 2019

Study information
Verified date August 2019
Source ARCIM Institute Academic Research in Complementary and Integrative Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 30
Est. completion date May 22, 2019
Est. primary completion date May 22, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

Related Conditions & MeSH terms

Intervention

Other:
• Ergometry H
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 periodmaximum load of 180 watts), followed by a 15-minute post-rest period. Mobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure (reference parameter). SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 are accordingly applied to the arm with the previously determined lower systolic blood pressure.
• Ergometry L
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 periodmaximum load of 180 watts), followed by a 15-minute post-rest period. Mobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure (reference parameter). SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 are accordingly applied to the arm with the previously determined higher systolic blood pressure.

Locations
Country Name City State
Germany ARCIM Institute Filderstadt Baden Württemberg

Sponsors (2)
Lead Sponsor Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine Universität Tübingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference of the systolic blood pressure 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 Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Diastolic Blood Pressure (SOMNOtouchTM RESP) Diastolic Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Mean Arterial Blood Pressure (SOMNOtouchTM RESP) Mean Arterial Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Pulse Pressure (SOMNOtouchTM RESP) Pulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Heartrate (SOMNOtouchTM RESP) Heartrate (beats per minute, bpm) measured with the SOMNOtouchTM RESP device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Oxygen saturation (SpO2, SOMNOtouchTM RESP) Oxygen saturation (% SpO2) measured with the SOMNOtouchTM RESP device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Pulse-Transit-Time (PTT, SOMNOtouchTM RESP) Pulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Systolic Blood Pressure measured with the device Mobil-O-Graph® PWA Systolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Diastolic Blood Pressure measured with the device Mobil-O-Graph® PWA Diastolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Mean Arterial Blood Pressure measured with the device Mobil-O-Graph® PWA Mean Arterial Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Pulse Pressure measured with the device Mobil-O-Graph® PWA Pulse Pressure (mmHg) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Heartrate (Mobil-O-Graph® PWA) Heartrate (beats per minute, bpm) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Puls Pressure Amplification (Mobil-O-Graph® PWA) Puls Pressure Amplification measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Stroke Volume (Mobil-O-Graph® PWA) Stroke Volume (ml) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Cardiac output (Mobil-O-Graph® PWA) Cardiac output (l/min) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Vascular Resistance (Mobil-O-Graph® PWA) Vascular Resistance (s*mmHg/ml) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Cardiac Index (Mobil-O-Graph® PWA) Cardiac Index (l/min*1/m2) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Augmentation Pressure (Mobil-O-Graph® PWA) Augmentation Pressure (mmHg) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Reflection Coefficient (Mobil-O-Graph® PWA) Reflection Coefficient (%) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Pulse Wave Velocity (PWV) (Mobil-O-Graph® PWA) Pulse Wave Velocity (PWV, m/s) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Systole Time (Mobil-O-Graph® PWA) Systole Time (s) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Tmax-forward (Mobil-O-Graph® PWA) Tmax-forward (s) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Tmax-backward (Mobil-O-Graph® PWA) Tmax-backward (s) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Forward Pressure (Mobil-O-Graph® PWA) Forward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Backward Pressure (Mobil-O-Graph® PWA) Backward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Pulse Transit Time (GeTeMed Vitaguard 3100) Pulse Transit Time (PTT, ms) measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Perfusion Index (GeTeMed Vitaguard 3100) Perfusion Index (PI) measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary Peak to Peak Time (PPT) (GeTeMed Vitaguard 3100) Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary SlopeInW1 (GeTeMed Vitaguard 3100) SlopeInW1 measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary SlopeInW2 (GeTeMed Vitaguard 3100) SlopeInW2 measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary SlopeInW3 (GeTeMed Vitaguard 3100) SlopeInW3 measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary SlopeInW4 (GeTeMed Vitaguard 3100) SlopeInW4 measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary StiffnessIndex (GeTeMed Vitaguard 3100) StiffnessIndex measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary ReflectionIndex (GeTeMed Vitaguard 3100) ReflectionIndex measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary TimeTX (GeTeMed Vitaguard 3100) TimeTX (ms) measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary TimeTY (GeTeMed Vitaguard 3100) TimeTY (ms) measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary QuotTYTX (GeTeMed Vitaguard 3100) QuotTYTX measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary AreaAX (GeTeMed Vitaguard 3100) AreaAX measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary AreaAY (GeTeMed Vitaguard 3100) AreaAY measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary QuotAYAX (GeTeMed Vitaguard 3100) QuotAYAX measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary AreaAV (GeTeMed Vitaguard 3100) AreaAV measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary AreaAW (GeTeMed Vitaguard 3100) AreaAW measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary QuotAWAV (GeTeMed Vitaguard 3100) QuotAWAV measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary QuotTVTW (GeTeMed Vitaguard 3100) QuotTVTW measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary TimeTV (GeTeMed Vitaguard 3100) TimeTV (ms) measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary TimeTW (GeTeMed Vitaguard 3100) TimeTW (ms) measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary MinT1 (GeTeMed Vitaguard 3100) Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the first peak Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary MinT2 (GeTeMed Vitaguard 3100) Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary MaxT1 (GeTeMed Vitaguard 3100) Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the first peak Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary MaxT2 (GeTeMed Vitaguard 3100) Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the second peak Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary QuotHRRespRate (GeTeMed Vitaguard 3100) Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 device Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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