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

Sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT03792893

Collaborator

Universität Tübingen (Other)

Enrollment

Location

Arms

3.5

Actual Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Female Subjects	Other: Ergometry H Other: Ergometry L	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jan 29, 2019

Actual Primary Completion Date :

May 17, 2019

Actual Study Completion Date :

May 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Higher Blood Pressure BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure. Intervention: Ergometry H	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. 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.
Experimental: Lower Blood Pressure BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure. Intervention: Ergometry L	Other: 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. 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.

Arm

Intervention/Treatment

Experimental: Higher Blood Pressure

BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure. Intervention: Ergometry H

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. 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.

Experimental: Lower Blood Pressure

BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure. Intervention: Ergometry L

Other: 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. 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.

Outcome Measures

Primary Outcome Measures

Difference of the systolic blood pressure [Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes]
Primary outcome is the difference of the systolic blood pressure values between the devices BOSO-TM-2430 versus SOMNOtouchTM RESP during the three phases

Secondary Outcome Measures

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 minutes]
Diastolic 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 minutes]
Mean 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 minutes]
Pulse 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 minutes]
Heartrate (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 minutes]
Oxygen 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 minutes]
Pulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device
Systolic Blood Pressure measured with the device BOSO-TM-2430 [Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes]
Systolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device
Diastolic Blood Pressure measured with the device BOSO-TM-2430 [Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes]
Diastolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device
Mean Arterial Blood Pressure measured with the device BOSO-TM-2430 [Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes]
Mean Arterial Blood Pressure (mmHg) measured with the BOSO-TM-2430 device
Pulse Pressure measured with the device BOSO-TM-2430 [Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes]
Pulse Pressure (mmHg) measured with the BOSO-TM-2430 device
Heartrate measured with the device BOSO-TM-2430 [Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes]
Heartrate (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 minutes]
Pulse 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 minutes]
Perfusion 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 minutes]
Peak 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 minutes]
SlopeInW1 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 minutes]
SlopeInW2 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 minutes]
SlopeInW3 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 minutes]
SlopeInW4 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 minutes]
StiffnessIndex 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 minutes]
ReflectionIndex measured with the GeTeMed Vitaguard 3100 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 minutes]
TimeTX (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 minutes]
TimeTY (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 minutes]
QuotTYTX 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 minutes]
AreaAX 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 minutes]
AreaAY 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 minutes]
QuotAYAX 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 minutes]
AreaAV 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 minutes]
AreaAW 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 minutes]
QuotAWAV 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 minutes]
QuotTVTW 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 minutes]
TimeTV (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 minutes]
TimeTW (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 minutes]
Minimum 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 minutes]
Minimum 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 minutes]
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 minutes (BOSO-TM-2430) for a total duration of 72 minutes]
Maximum 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 minutes]
Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 device

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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)