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

NCT03792893 | Completed

• 1 other identifier: ERG_03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Female Subjects

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (37)

• 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

• 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

• 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

• Heartrate (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, SOMNOtouchTM RESP)

  Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes

Study Arms (2)

Higher Blood Pressure

EXPERIMENTAL

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

Lower Blood Pressure

EXPERIMENTAL

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

Interventions

Ergometry H OTHER

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.

Higher Blood Pressure

Ergometry L OTHER

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.

Lower Blood Pressure

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• ARCIM Institute Academic Research in Complementary and Integrative Medicine: lead
• Universität Tübingen: collaborator

Study Sites (1)

ARCIM Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

Study Officials

• Jan Vagedes, MD

  ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 4, 2019
• Study Start: January 29, 2019
• Primary Completion: May 17, 2019
• Study Completion: May 17, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

DE (1)