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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

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.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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

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.

Eksperimentel: 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

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference of the systolic blood pressure
Tidsramme: 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
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diastolic Blood Pressure (SOMNOtouchTM RESP)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Heartrate (SOMNOtouchTM RESP)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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
Tidsramme: 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
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
Tidsramme: 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
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
Tidsramme: 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
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
Tidsramme: 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
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
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
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)
Tidsramme: 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
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Studieleder: Jan Vagedes, MD, ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. januar 2019

Primær færdiggørelse (Faktiske)

17. maj 2019

Studieafslutning (Faktiske)

17. maj 2019

Datoer for studieregistrering

Først indsendt

2. januar 2019

Først indsendt, der opfyldte QC-kriterier

3. januar 2019

Først opslået (Faktiske)

4. januar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ERG_03

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Kliniske forsøg med Ergometry H

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