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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Female Subjects
• Intervention / Treatment: Other: Ergometry H; Other: Ergometry L

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden Württemberg
    • Filderstadt, Baden Württemberg, Germany, 70794
      • Arcim Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Pulse Pressure (SOMNOtouchTM RESP)	Pulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Heartrate (SOMNOtouchTM RESP)	Heartrate (beats per minute, bpm) measured with the SOMNOtouchTM RESP device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Oxygen saturation (SpO2, SOMNOtouchTM RESP)	Oxygen saturation (% SpO2) measured with the SOMNOtouchTM RESP device	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, SOMNOtouchTM RESP)	Pulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Systolic Blood Pressure measured with the device BOSO-TM-2430	Systolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Diastolic Blood Pressure measured with the device BOSO-TM-2430	Diastolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device	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 measured with the device BOSO-TM-2430	Mean Arterial Blood Pressure (mmHg) measured with the BOSO-TM-2430 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Pulse Pressure measured with the device BOSO-TM-2430	Pulse Pressure (mmHg) measured with the BOSO-TM-2430 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Heartrate measured with the device BOSO-TM-2430	Heartrate (beats per minute, bpm) measured with the BOSO-TM-2430 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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 minutes (BOSO-TM-2430) for a total duration of 72 minutes
SlopeInW1 (GeTeMed Vitaguard 3100)	SlopeInW1 measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
SlopeInW2 (GeTeMed Vitaguard 3100)	SlopeInW2 measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
SlopeInW3 (GeTeMed Vitaguard 3100)	SlopeInW3 measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
SlopeInW4 (GeTeMed Vitaguard 3100)	SlopeInW4 measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
StiffnessIndex (GeTeMed Vitaguard 3100)	StiffnessIndex measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
ReflectionIndex (GeTeMed Vitaguard 3100)	ReflectionIndex measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
TimeTX (GeTeMed Vitaguard 3100)	TimeTX (ms) measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
TimeTY (GeTeMed Vitaguard 3100)	TimeTY (ms) measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
QuotTYTX (GeTeMed Vitaguard 3100)	QuotTYTX measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
AreaAX (GeTeMed Vitaguard 3100)	AreaAX measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
AreaAY (GeTeMed Vitaguard 3100)	AreaAY measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
QuotAYAX (GeTeMed Vitaguard 3100)	QuotAYAX measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
AreaAV (GeTeMed Vitaguard 3100)	AreaAV measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
AreaAW (GeTeMed Vitaguard 3100)	AreaAW measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
QuotAWAV (GeTeMed Vitaguard 3100)	QuotAWAV measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
QuotTVTW (GeTeMed Vitaguard 3100)	QuotTVTW measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
TimeTV (GeTeMed Vitaguard 3100)	TimeTV (ms) measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
TimeTW (GeTeMed Vitaguard 3100)	TimeTW (ms) measured with the GeTeMed Vitaguard 3100 device	Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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 minutes (BOSO-TM-2430) for a total duration of 72 minutes

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Collaborators: Universität Tübingen
• Investigators: Study Director: Jan Vagedes, MD, ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Actual): May 17, 2019
• Study Completion (Actual): May 17, 2019

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Blood Pressure; Ergometry; Cardiovascular parameters; Pulse Wave; Somnotouch; BOSO-TM-2430
• Other Study ID Numbers: ERG_03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No