Healthy Male Subjects Clinical Trial
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.
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.
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