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
| Type | Name | Description |
|---|---|---|
| DEVICE | Biothesiometry | Biothesiometry using Biothesiometer (Bio Medical Instrument Co, Ohio, United States of America), placed on glans penis and second finger of nondominant hand. |
| DEVICE | Transcutaneous blood gas monitoring | Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis. |
| DEVICE | Cycling on a home trainer | Riding 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. |
| DEVICE | Bike Fitting | Setting standardized posture of the rider on the bike using Retül technology (Retül, Specialized Bicycle Components Inc., Boulder, Colorado, United States of America) |
| DEVICE | Heart rate monitoring | Measuring heart rate using Wahoo TICKR chest strap (Wahoo Fitness LLC, Atlanta, Georgia, United States of America) |
| DEVICE | Velomotrik smart cover BT | Saddle 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.