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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Baden Württemberg
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Filderstadt、Baden Württemberg、ドイツ、70794
- Arcim Institute
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～40年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
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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. |
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実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference of the systolic blood pressure
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diastolic Blood Pressure (SOMNOtouchTM RESP)
時間枠：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
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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)
時間枠：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
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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)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Pulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
|
Heartrate (SOMNOtouchTM RESP)
時間枠：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
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Oxygen saturation (SpO2, SOMNOtouchTM RESP)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Oxygen saturation (% SpO2) measured with the SOMNOtouchTM RESP device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Pulse-Transit-Time (PTT, SOMNOtouchTM RESP)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Pulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Systolic Blood Pressure measured with the device BOSO-TM-2430
時間枠：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
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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
時間枠：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
|
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Mean Arterial Blood Pressure measured with the device BOSO-TM-2430
時間枠：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
|
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Pulse Pressure measured with the device BOSO-TM-2430
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Pulse Pressure (mmHg) measured with the BOSO-TM-2430 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Heartrate measured with the device BOSO-TM-2430
時間枠：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
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Pulse Transit Time (GeTeMed Vitaguard 3100)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Pulse Transit Time (PTT, ms) measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Perfusion Index (GeTeMed Vitaguard 3100)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Perfusion Index (PI) measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Peak to Peak Time (PPT) (GeTeMed Vitaguard 3100)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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SlopeInW1 (GeTeMed Vitaguard 3100)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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SlopeInW1 measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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SlopeInW2 (GeTeMed Vitaguard 3100)
時間枠：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
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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SlopeInW3 (GeTeMed Vitaguard 3100)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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SlopeInW3 measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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SlopeInW4 (GeTeMed Vitaguard 3100)
時間枠：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
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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StiffnessIndex (GeTeMed Vitaguard 3100)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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StiffnessIndex measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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ReflectionIndex (GeTeMed Vitaguard 3100)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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ReflectionIndex measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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TimeTX (GeTeMed Vitaguard 3100)
時間枠：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
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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)
時間枠：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
|
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QuotTYTX (GeTeMed Vitaguard 3100)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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QuotTYTX measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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AreaAX (GeTeMed Vitaguard 3100)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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AreaAX measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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AreaAY (GeTeMed Vitaguard 3100)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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AreaAY measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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QuotAYAX (GeTeMed Vitaguard 3100)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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QuotAYAX measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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AreaAV (GeTeMed Vitaguard 3100)
時間枠：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)
時間枠：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
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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QuotAWAV (GeTeMed Vitaguard 3100)
時間枠：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
|
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QuotTVTW (GeTeMed Vitaguard 3100)
時間枠：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)
時間枠：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)
時間枠：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
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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MinT1 (GeTeMed Vitaguard 3100)
時間枠：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
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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MinT2 (GeTeMed Vitaguard 3100)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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MaxT1 (GeTeMed Vitaguard 3100)
時間枠：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
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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MaxT2 (GeTeMed Vitaguard 3100)
時間枠：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
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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QuotHRRespRate (GeTeMed Vitaguard 3100)
時間枠：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Jan Vagedes, MD、ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年1月29日
一次修了 (実際)
2019年5月17日
研究の完了 (実際)
2019年5月17日
試験登録日
最初に提出
2019年1月2日
QC基準を満たした最初の提出物
2019年1月3日
最初の投稿 (実際)
2019年1月4日
学習記録の更新
投稿された最後の更新 (実際)
2019年8月7日
QC基準を満たした最後の更新が送信されました
2019年8月6日
最終確認日
2019年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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