Clinical trial NCT03790722: Comparison of Pulse Wave and Blood Pressure Measurements Before, During and After Ergometry in Healthy Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Male Subjects
Keywords: Cardiovascular parameters
Blood Pressure
Pulse Wave
Ergometry
MobiloGraph
Somnotouch
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
Collaborators: name: Universität Tübingen
First posted: 2019-01-02
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Difference of the systolic blood pressure
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary outcomes:
measure: Diastolic Blood Pressure (SOMNOtouchTM RESP)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Mean Arterial Blood Pressure (SOMNOtouchTM RESP)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Pulse Pressure (SOMNOtouchTM RESP)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Heartrate (SOMNOtouchTM RESP)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Oxygen saturation (SpO2, SOMNOtouchTM RESP)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Pulse-Transit-Time (PTT, SOMNOtouchTM RESP)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Systolic Blood Pressure measured with the device Mobil-O-Graph® PWA
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Diastolic Blood Pressure measured with the device Mobil-O-Graph® PWA
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Mean Arterial Blood Pressure measured with the device Mobil-O-Graph® PWA
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Pulse Pressure measured with the device Mobil-O-Graph® PWA
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Heartrate (Mobil-O-Graph® PWA)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Puls Pressure Amplification (Mobil-O-Graph® PWA)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Stroke Volume (Mobil-O-Graph® PWA)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Cardiac output (Mobil-O-Graph® PWA)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Vascular Resistance (Mobil-O-Graph® PWA)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Cardiac Index (Mobil-O-Graph® PWA)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Augmentation Pressure (Mobil-O-Graph® PWA)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Reflection Coefficient (Mobil-O-Graph® PWA)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Pulse Wave Velocity (PWV) (Mobil-O-Graph® PWA)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Systole Time (Mobil-O-Graph® PWA)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Tmax-forward (Mobil-O-Graph® PWA)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Tmax-backward (Mobil-O-Graph® PWA)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Forward Pressure (Mobil-O-Graph® PWA)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Backward Pressure (Mobil-O-Graph® PWA)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Pulse Transit Time (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Perfusion Index (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: Peak to Peak Time (PPT) (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: SlopeInW1 (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: SlopeInW2 (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: SlopeInW3 (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: SlopeInW4 (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: StiffnessIndex (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: ReflectionIndex (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: TimeTX (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: TimeTY (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: QuotTYTX (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: AreaAX (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: AreaAY (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: QuotAYAX (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: AreaAV (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: AreaAW (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: QuotAWAV (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: QuotTVTW (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: TimeTV (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: TimeTW (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: MinT1 (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: MinT2 (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: MaxT1 (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: MaxT2 (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
measure: QuotHRRespRate (GeTeMed Vitaguard 3100)
timeFrame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: ARCIM Institute
state: Baden Württemberg
Study officials:
affiliation: ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany
name: Jan Vagedes, MD
role: STUDY_DIRECTOR
References: