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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03790722
Enrollment
30
Registered
2019-01-02
Start date
2019-01-28
Completion date
2019-05-22
Last updated
2019-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Subjects

Keywords

Cardiovascular parameters, Blood Pressure, Pulse Wave, Ergometry, MobiloGraph, Somnotouch

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.

Interventions

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.

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.

Sponsors

Universität Tübingen
CollaboratorOTHER
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Difference of the systolic blood pressurePhysiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 minPrimary 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

MeasureTime frameDescription
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 minMean Arterial 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 minPulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP 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 minHeartrate (beats per minute, bpm) 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 minOxygen saturation (% SpO2) 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 minPulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device
Systolic Blood Pressure measured with the device Mobil-O-Graph® PWAPhysiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 minSystolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
Diastolic Blood Pressure measured with the device Mobil-O-Graph® PWAPhysiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 minDiastolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
Mean Arterial Blood Pressure measured with the device Mobil-O-Graph® PWAPhysiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 minMean Arterial Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
Pulse Pressure measured with the device Mobil-O-Graph® PWAPhysiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 minPulse 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 minHeartrate (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 minPuls Pressure Amplification measured with the Mobil-O-Graph® PWA 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 minStroke Volume (ml) 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 minCardiac output (l/min) 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 minVascular 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 minCardiac 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 minAugmentation 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 minReflection Coefficient (%) 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 minPulse Wave Velocity (PWV, m/s) 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 minSystole Time (s) 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 minTmax-forward (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 minTmax-backward (s) measured with the Mobil-O-Graph® PWA 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 minForward 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 minBackward Pressure (mmHg) 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 minPulse Transit Time (PTT, ms) measured with the GeTeMed Vitaguard 3100 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 minPerfusion Index (PI) 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 minPeak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100 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 minSlopeInW1 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 minSlopeInW2 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 minSlopeInW3 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 minSlopeInW4 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 minStiffnessIndex 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 minReflectionIndex 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 minTimeTX (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 minTimeTY (ms) 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 minQuotTYTX 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 minAreaAX 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 minAreaAY 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 minQuotAYAX 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 minAreaAV 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 minAreaAW 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 minQuotAWAV 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 minQuotTVTW 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 minTimeTV (ms) measured with the GeTeMed Vitaguard 3100 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 minDiastolic Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP 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 minMinimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the first peak
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 minMinimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second 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 minMaximum 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 minMaximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum 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 minQuotient of heart and respiratory rates 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 minTimeTW (ms) measured with the GeTeMed Vitaguard 3100 device

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026