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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03792893
Enrollment
30
Registered
2019-01-04
Start date
2019-01-29
Completion date
2019-05-17
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 Female Subjects

Keywords

Cardiovascular parameters, Blood Pressure, Pulse Wave, Ergometry, Somnotouch, BOSO-TM-2430

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 female 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 (BOSO-TM-2430 ) under standardized load conditions (ergometry). In 30 healthy female 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 (BOSO-TM-2430 versus SOMNOtouchTM RESP versus GeTeMed Vitaguard 3100) and compared. Primary outcome is the difference of the systolic blood pressure values between the devices BOSO-TM-2430 versus SOMNOtouchTM RESP during the three phases. The BOSO-TM-2430 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 BOSO-TM-2430; 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. BOSO-TM-2430 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. BOSO-TM-2430 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
FEMALE
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 minutes (BOSO-TM-2430) for a total duration of 72 minutesPrimary outcome is the difference of the systolic blood pressure values between the devices BOSO-TM-2430 versus SOMNOtouchTM RESP during the three phases

Secondary

MeasureTime frameDescription
Diastolic Blood Pressure (SOMNOtouchTM RESP)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesDiastolic Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
Mean Arterial Blood Pressure (SOMNOtouchTM RESP)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesMean 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 minutes (BOSO-TM-2430) for a total duration of 72 minutesPulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
Heartrate (SOMNOtouchTM RESP)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesHeartrate (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 minutes (BOSO-TM-2430) for a total duration of 72 minutesOxygen saturation (% SpO2) measured with the SOMNOtouchTM RESP device
Pulse-Transit-Time (PTT, SOMNOtouchTM RESP)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesPulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device
Systolic Blood Pressure measured with the device BOSO-TM-2430Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesSystolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device
Mean Arterial Blood Pressure measured with the device BOSO-TM-2430Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesMean Arterial Blood Pressure (mmHg) measured with the BOSO-TM-2430 device
Pulse Pressure measured with the device BOSO-TM-2430Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesPulse Pressure (mmHg) measured with the BOSO-TM-2430 device
Heartrate measured with the device BOSO-TM-2430Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesHeartrate (beats per minute, bpm) measured with the BOSO-TM-2430 device
Pulse Transit Time (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesPulse 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 minutes (BOSO-TM-2430) for a total duration of 72 minutesPerfusion 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 minutes (BOSO-TM-2430) for a total duration of 72 minutesPeak 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 minutes (BOSO-TM-2430) for a total duration of 72 minutesSlopeInW1 measured with the GeTeMed Vitaguard 3100 device
SlopeInW2 (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesSlopeInW2 measured with the GeTeMed Vitaguard 3100 device
SlopeInW3 (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesSlopeInW3 measured with the GeTeMed Vitaguard 3100 device
SlopeInW4 (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesSlopeInW4 measured with the GeTeMed Vitaguard 3100 device
StiffnessIndex (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesStiffnessIndex measured with the GeTeMed Vitaguard 3100 device
Diastolic Blood Pressure measured with the device BOSO-TM-2430Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesDiastolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device
TimeTX (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesTimeTX (ms) measured with the GeTeMed Vitaguard 3100 device
TimeTY (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesTimeTY (ms) measured with the GeTeMed Vitaguard 3100 device
QuotTYTX (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesQuotTYTX measured with the GeTeMed Vitaguard 3100 device
AreaAX (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesAreaAX measured with the GeTeMed Vitaguard 3100 device
AreaAY (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesAreaAY measured with the GeTeMed Vitaguard 3100 device
QuotAYAX (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesQuotAYAX measured with the GeTeMed Vitaguard 3100 device
AreaAV (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesAreaAV measured with the GeTeMed Vitaguard 3100 device
AreaAW (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesAreaAW measured with the GeTeMed Vitaguard 3100 device
QuotAWAV (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesQuotAWAV measured with the GeTeMed Vitaguard 3100 device
QuotTVTW (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesQuotTVTW measured with the GeTeMed Vitaguard 3100 device
TimeTV (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesTimeTV (ms) measured with the GeTeMed Vitaguard 3100 device
TimeTW (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesTimeTW (ms) measured with the GeTeMed Vitaguard 3100 device
MinT1 (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesMinimum 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 minutes (BOSO-TM-2430) for a total duration of 72 minutesMinimum 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 minutes (BOSO-TM-2430) for a total duration of 72 minutesMaximum 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 minutes (BOSO-TM-2430) for a total duration of 72 minutesMaximum 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 minutes (BOSO-TM-2430) for a total duration of 72 minutesQuotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 device
ReflectionIndex (GeTeMed Vitaguard 3100)Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutesReflectionIndex measured with the GeTeMed Vitaguard 3100 device

Countries

Germany

Outcome results

None listed

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