Healthy Male SubjectsNCT03790722
Comparison of Pulse Wave and Blood Pressure Measurements Before, During and After Ergometry in Healthy Men
A study testing Ergometry H and Ergometry L in people with Healthy Male Subjects, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial 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 male subjects. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- Ergometry H and Ergometry L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jan 2019to 22 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Healthy Male Subjects
- Being tested
- Ergometry H, Ergometry L
- Keywords
- Cardiovascular parameters, Blood Pressure, Pulse Wave, Ergometry, MobiloGraph, Somnotouch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergometry HOther
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 LOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Higher Blood Pressure | Experimental | Mobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure. Intervention: Ergometry H Receives: Other: Ergometry H |
| Lower Blood Pressure | Experimental | Mobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure. Intervention: Ergometry L Receives: Other: Ergometry L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the systolic blood pressure
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
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Secondary outcomes (50)
Diastolic Blood Pressure (SOMNOtouchTM RESP)
Diastolic Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
Measured: 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 (SOMNOtouchTM RESP)
Mean Arterial Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Pulse Pressure (SOMNOtouchTM RESP)
Pulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Heartrate (SOMNOtouchTM RESP)
Heartrate (beats per minute, bpm) measured with the SOMNOtouchTM RESP device
Measured: 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, SOMNOtouchTM RESP)
Oxygen saturation (% SpO2) measured with the SOMNOtouchTM RESP device
Measured: 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, SOMNOtouchTM RESP)
Pulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device
Measured: 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 measured with the device Mobil-O-Graph® PWA
Systolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
Measured: 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 measured with the device Mobil-O-Graph® PWA
Diastolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
Measured: 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 measured with the device Mobil-O-Graph® PWA
Mean Arterial Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Pulse Pressure measured with the device Mobil-O-Graph® PWA
Pulse Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Heartrate (Mobil-O-Graph® PWA)
Heartrate (beats per minute, bpm) measured with the Mobil-O-Graph® PWA device
Measured: 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 (Mobil-O-Graph® PWA)
Puls Pressure Amplification measured with the Mobil-O-Graph® PWA device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Stroke Volume (Mobil-O-Graph® PWA)
Stroke Volume (ml) measured with the Mobil-O-Graph® PWA device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Cardiac output (Mobil-O-Graph® PWA)
Cardiac output (l/min) measured with the Mobil-O-Graph® PWA device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Vascular Resistance (Mobil-O-Graph® PWA)
Vascular Resistance (s*mmHg/ml) measured with the Mobil-O-Graph® PWA device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Cardiac Index (Mobil-O-Graph® PWA)
Cardiac Index (l/min*1/m2) measured with the Mobil-O-Graph® PWA device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Augmentation Pressure (Mobil-O-Graph® PWA)
Augmentation Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Reflection Coefficient (Mobil-O-Graph® PWA)
Reflection Coefficient (%) measured with the Mobil-O-Graph® PWA device
Measured: 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) (Mobil-O-Graph® PWA)
Pulse Wave Velocity (PWV, m/s) measured with the Mobil-O-Graph® PWA device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Systole Time (Mobil-O-Graph® PWA)
Systole Time (s) measured with the Mobil-O-Graph® PWA device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Tmax-forward (Mobil-O-Graph® PWA)
Tmax-forward (s) measured with the Mobil-O-Graph® PWA device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Tmax-backward (Mobil-O-Graph® PWA)
Tmax-backward (s) measured with the Mobil-O-Graph® PWA device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Forward Pressure (Mobil-O-Graph® PWA)
Forward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Backward Pressure (Mobil-O-Graph® PWA)
Backward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
Measured: 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 (GeTeMed Vitaguard 3100)
Pulse Transit Time (PTT, ms) measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Perfusion Index (GeTeMed Vitaguard 3100)
Perfusion Index (PI) measured with the GeTeMed Vitaguard 3100 device
Measured: 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) (GeTeMed Vitaguard 3100)
Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
SlopeInW1 (GeTeMed Vitaguard 3100)
SlopeInW1 measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
SlopeInW2 (GeTeMed Vitaguard 3100)
SlopeInW2 measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
SlopeInW3 (GeTeMed Vitaguard 3100)
SlopeInW3 measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
SlopeInW4 (GeTeMed Vitaguard 3100)
SlopeInW4 measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
StiffnessIndex (GeTeMed Vitaguard 3100)
StiffnessIndex measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
ReflectionIndex (GeTeMed Vitaguard 3100)
ReflectionIndex measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
TimeTX (GeTeMed Vitaguard 3100)
TimeTX (ms) measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
TimeTY (GeTeMed Vitaguard 3100)
TimeTY (ms) measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
QuotTYTX (GeTeMed Vitaguard 3100)
QuotTYTX measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
AreaAX (GeTeMed Vitaguard 3100)
AreaAX measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
AreaAY (GeTeMed Vitaguard 3100)
AreaAY measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
QuotAYAX (GeTeMed Vitaguard 3100)
QuotAYAX measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
AreaAV (GeTeMed Vitaguard 3100)
AreaAV measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
AreaAW (GeTeMed Vitaguard 3100)
AreaAW measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
QuotAWAV (GeTeMed Vitaguard 3100)
QuotAWAV measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
QuotTVTW (GeTeMed Vitaguard 3100)
QuotTVTW measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
TimeTV (GeTeMed Vitaguard 3100)
TimeTV (ms) measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
TimeTW (GeTeMed Vitaguard 3100)
TimeTW (ms) measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
MinT1 (GeTeMed Vitaguard 3100)
Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the first peak
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
MinT2 (GeTeMed Vitaguard 3100)
Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
MaxT1 (GeTeMed Vitaguard 3100)
Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the first peak
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
MaxT2 (GeTeMed Vitaguard 3100)
Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the second peak
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
QuotHRRespRate (GeTeMed Vitaguard 3100)
Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 device
Measured: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start28 Jan 2019
- Primary completion22 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Tübingen
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, MD, Study director, ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790722
- Sponsor's protocol ID
- ERG_02
- Status last verified
- Aug 2019
- First submitted
- 27 Dec 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03790722
- Acronym / sponsor ID
- ERG_02
- Conditions
- Healthy Male Subjects
- Keywords
- Cardiovascular parameters, Blood Pressure, Pulse Wave, Ergometry, MobiloGraph, Somnotouch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Collaborators
- Universität Tübingen
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher Blood Pressure | Experimental | Other: Ergometry HMobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure. Intervention: Ergometry H |
| Lower Blood Pressure | Experimental | Other: Ergometry LMobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure. Intervention: Ergometry L |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergometry HAfter 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. | Other | Higher Blood Pressure |
| Ergometry LAfter 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. | Other | Lower Blood Pressure |
Primary outcome
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
50 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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-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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Vagedes, MD study director
ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergometry H and Ergometry L in people with Healthy Male Subjects, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.