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NCT Number: NCT03790722

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

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 male subjects.

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Key information

Conditions

Healthy Male Subjects

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

ARCIM Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

About this study

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 (Mobil-O-Graph® PWA) under standardized load conditions (ergometry).

In 30 healthy male 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 (Mobil-O-Graph® PWA versus SOMNOtouchTM RESP versus GeTeMed Vitaguard 3100) and compared.

Primary outcome is the difference of the systolic blood pressure values between the devices Mobil-O-Graph® PWA versus SOMNOtouchTM RESP during the three phases.

The Mobil-O-Graph® PWA 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 Mobil-O-Graph® PWA; data acquisition with the SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 devices takes place continuously over a total duration of 72 minutes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Mobil-O-Graph PWA 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.

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.

Mobil-O-Graph PWA 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.

Primary outcomes

  1. Difference of the systolic blood pressure

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Primary outcome is the difference of the systolic blood pressure values between the devices Mobil-O-Graph® PWA versus SOMNOtouchTM RESP during the three phases

Secondary outcomes

  1. Diastolic Blood Pressure (SOMNOtouchTM RESP)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Diastolic Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device

  2. Mean Arterial Blood Pressure (SOMNOtouchTM RESP)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Mean Arterial Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device

  3. Pulse Pressure (SOMNOtouchTM RESP)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Pulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP device

  4. Heartrate (SOMNOtouchTM RESP)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Heartrate (beats per minute, bpm) measured with the SOMNOtouchTM RESP device

  5. Oxygen saturation (SpO2, SOMNOtouchTM RESP)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Oxygen saturation (% SpO2) measured with the SOMNOtouchTM RESP device

  6. Pulse-Transit-Time (PTT, SOMNOtouchTM RESP)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Pulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device

  7. Systolic Blood Pressure measured with the device Mobil-O-Graph® PWA

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Systolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device

  8. Diastolic Blood Pressure measured with the device Mobil-O-Graph® PWA

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Diastolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device

  9. Mean Arterial Blood Pressure measured with the device Mobil-O-Graph® PWA

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Mean Arterial Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device

  10. Pulse Pressure measured with the device Mobil-O-Graph® PWA

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Pulse Pressure (mmHg) measured with the Mobil-O-Graph® PWA device

  11. Heartrate (Mobil-O-Graph® PWA)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Heartrate (beats per minute, bpm) measured with the Mobil-O-Graph® PWA device

  12. Puls Pressure Amplification (Mobil-O-Graph® PWA)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Puls Pressure Amplification measured with the Mobil-O-Graph® PWA device

  13. Stroke Volume (Mobil-O-Graph® PWA)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Stroke Volume (ml) measured with the Mobil-O-Graph® PWA device

  14. Cardiac output (Mobil-O-Graph® PWA)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Cardiac output (l/min) measured with the Mobil-O-Graph® PWA device

  15. Vascular Resistance (Mobil-O-Graph® PWA)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Vascular Resistance (s*mmHg/ml) measured with the Mobil-O-Graph® PWA device

  16. Cardiac Index (Mobil-O-Graph® PWA)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Cardiac Index (l/min*1/m2) measured with the Mobil-O-Graph® PWA device

  17. Augmentation Pressure (Mobil-O-Graph® PWA)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Augmentation Pressure (mmHg) measured with the Mobil-O-Graph® PWA device

  18. Reflection Coefficient (Mobil-O-Graph® PWA)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Reflection Coefficient (%) measured with the Mobil-O-Graph® PWA device

  19. Pulse Wave Velocity (PWV) (Mobil-O-Graph® PWA)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Pulse Wave Velocity (PWV, m/s) measured with the Mobil-O-Graph® PWA device

  20. Systole Time (Mobil-O-Graph® PWA)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Systole Time (s) measured with the Mobil-O-Graph® PWA device

  21. Tmax-forward (Mobil-O-Graph® PWA)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Tmax-forward (s) measured with the Mobil-O-Graph® PWA device

  22. Tmax-backward (Mobil-O-Graph® PWA)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Tmax-backward (s) measured with the Mobil-O-Graph® PWA device

  23. Forward Pressure (Mobil-O-Graph® PWA)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Forward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device

  24. Backward Pressure (Mobil-O-Graph® PWA)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Backward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device

  25. Pulse Transit Time (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Pulse Transit Time (PTT, ms) measured with the GeTeMed Vitaguard 3100 device

  26. Perfusion Index (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Perfusion Index (PI) measured with the GeTeMed Vitaguard 3100 device

  27. Peak to Peak Time (PPT) (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100 device

  28. SlopeInW1 (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    SlopeInW1 measured with the GeTeMed Vitaguard 3100 device

  29. SlopeInW2 (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    SlopeInW2 measured with the GeTeMed Vitaguard 3100 device

  30. SlopeInW3 (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    SlopeInW3 measured with the GeTeMed Vitaguard 3100 device

  31. SlopeInW4 (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    SlopeInW4 measured with the GeTeMed Vitaguard 3100 device

  32. StiffnessIndex (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    StiffnessIndex measured with the GeTeMed Vitaguard 3100 device

  33. ReflectionIndex (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    ReflectionIndex measured with the GeTeMed Vitaguard 3100 device

  34. TimeTX (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    TimeTX (ms) measured with the GeTeMed Vitaguard 3100 device

  35. TimeTY (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    TimeTY (ms) measured with the GeTeMed Vitaguard 3100 device

  36. QuotTYTX (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    QuotTYTX measured with the GeTeMed Vitaguard 3100 device

  37. AreaAX (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    AreaAX measured with the GeTeMed Vitaguard 3100 device

  38. AreaAY (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    AreaAY measured with the GeTeMed Vitaguard 3100 device

  39. QuotAYAX (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    QuotAYAX measured with the GeTeMed Vitaguard 3100 device

  40. AreaAV (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    AreaAV measured with the GeTeMed Vitaguard 3100 device

  41. AreaAW (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    AreaAW measured with the GeTeMed Vitaguard 3100 device

  42. QuotAWAV (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    QuotAWAV measured with the GeTeMed Vitaguard 3100 device

  43. QuotTVTW (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    QuotTVTW measured with the GeTeMed Vitaguard 3100 device

  44. TimeTV (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    TimeTV (ms) measured with the GeTeMed Vitaguard 3100 device

  45. TimeTW (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    TimeTW (ms) measured with the GeTeMed Vitaguard 3100 device

  46. MinT1 (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the first peak

  47. MinT2 (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak

  48. MaxT1 (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the first peak

  49. MaxT2 (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the second peak

  50. QuotHRRespRate (GeTeMed Vitaguard 3100)

    Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min

    Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 device

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Collaborators

  • Universität Tübingen

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2019
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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