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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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Baden Württemberg
      • Filderstadt, Baden Württemberg, Alemanha, 70794
        • ARCIM Institute

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 40 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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

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

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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Difference of the systolic blood pressure
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Diastolic Blood Pressure (SOMNOtouchTM RESP)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Colaboradores

Investigadores

  • Diretor de estudo: Jan Vagedes, MD, ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

29 de janeiro de 2019

Conclusão Primária (Real)

17 de maio de 2019

Conclusão do estudo (Real)

17 de maio de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

2 de janeiro de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de janeiro de 2019

Primeira postagem (Real)

4 de janeiro de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de agosto de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de agosto de 2019

Última verificação

1 de agosto de 2019

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • ERG_03

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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