Clinical Trials Directory

Trials / Completed

CompletedNCT05887193

Effects of Contemporary Cycling Saddle Designs on Penile Transcutaneus Oxygen and Carbon Dioxide Levels in Elite Road Cyclists Riding on a Stationary Trainer

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Milan Martínek · Academic / Other
Sex
Male
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

Aim of this research is to compare novel 3D printed cycling saddle with the bestselling saddles from two major cycling manufacturers in terms of effects on penile blood gasses and update these findings on current style of racing cycling saddles.

Detailed description

The aim of this research is to investigate whether Posedla's 3D printed and custom-made prototype bicycle saddle Joyseat (Posedla s.r.o., Varnsdorf, Czech Republic) provide a benefit in terms of increased penile blood flow compared to the best-selling saddles from two major bicycle manufacturers. The method chosen to measure blood flow, which is commonly used in studies of this type, is referred to as transcutaneus blood gas monitoring. Measurement of TcPO2 and TcPCO2 in cyclists will be performed while riding on a cycling trainer using Radiometer TCM5 Flex (Radiometer Medical ApS, Brønshøj, Denmark) and a tc 84 electrode placed on the glans penis. Prior to the actual penile blood flow measurements, the sensitivity level of the n. pudendus (n. dorsalis penis) will be verified using biothesiometer (Bio Medical Instruments Co., Newbury, Ohio, USA), which is again commonly used in studies of this type. The pressure of the riders contact surfaces on the saddle will be evaluated with Velometrik SmartCover BT pressure mat (Velometrik GmbH, Neukieritzsch, Germany). The Wahoo KICKR Bike (Wahoo Fitness, LLC., Atlanta, Georgia, United States of America) will be used in the study, which, in addition to the possibility of individual seating adjustment, also allows to record the cyclists power and heart rate using a chest strap. The cyclists position on the bike will be measured and evaluated by infrared sensors and Retül technology (Specialized Bicycle Components, Inc., Morgan Hill, California, USA). The test will be performed using the described instrumentation in the Applied Kinesiology Laboratory at Charles University in Prague, Faculty of Physical Education and Sports and will involve riding 3x 10 minutes with 5 minutes rest in between intervals on the cycle trainer at 65-85% of the cyclists maximum individual heart rate during one visit. All measurement methods and devices are non-invasive and painless. The choice of instruments was based on their use in previously published studies of similar type and on their quality, i.e., the parameters of validity, reliability, sensitivity, specificity and availability.

Conditions

Interventions

TypeNameDescription
DEVICEBiothesiometryBiothesiometry using Biothesiometer (Bio Medical Instrument Co, Ohio, United States of America), placed on glans penis and second finger of nondominant hand.
DEVICETranscutaneous blood gas monitoringPenile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.
DEVICECycling on a home trainerRiding a static bike Wahoo Bike (Wahoo Fitness LLC, Atlanta, Georgia, United States of America) for 3x 10 minutes in Zone 3 (Andy Coggan methodology) calculated from each individual subjects self reported Functional Threshold Power.
DEVICEBike FittingSetting standardized posture of the rider on the bike using Retül technology (Retül, Specialized Bicycle Components Inc., Boulder, Colorado, United States of America)
DEVICEHeart rate monitoringMeasuring heart rate using Wahoo TICKR chest strap (Wahoo Fitness LLC, Atlanta, Georgia, United States of America)
DEVICEVelomotrik smart cover BTSaddle pressure measurement, mean and max saddle pressure, saddle pressure distribution. (Velometrik GmbH, Neukieritzsch, Germany).

Timeline

Start date
2023-04-21
Primary completion
2023-05-14
Completion
2023-05-14
First posted
2023-06-02
Last updated
2025-12-30

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT05887193. Inclusion in this directory is not an endorsement.