HealthyEC-SADDLENCT05887193
Effects of Contemporary Cycling Saddle Designs on Penile Transcutaneus Oxygen and Carbon Dioxide Levels in Elite Road Cyclists Riding on a Stationary Trainer
A study testing Biothesiometry, Transcutaneous blood gas monitoring and Cycling on a home trainer in people with Healthy and Cyclists, run by Milan Martínek at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Cyclists, Blood Gas Monitoring, Transcutaneous
- What is being tested?
- Biothesiometry, Transcutaneous blood gas monitoring and Cycling on a home trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCzechia
- Study dates
- 21 Apr 2023to 14 May 2023
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- gender: male, age: 18-45 years, discipline: road cycling, annual mileage: more than 14000 km (Tier 3-4)
Who cannot join
- Participants other than male, diagnosed with erectile dysfunction, acute or chronic back pain, acute (especially infectious) illness or injury, and in recovery from illness or injury are not eligible for inclusion in the research
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Biothesiometry, Transcutaneous blood gas monitoring, Cycling on a home trainer, Bike Fitting, Heart rate monitoring
- Keywords
- saddle, pressure, bicycling, erectile dysfunction, hypesthesia, transcutaneous blood gas monitoring, bike fit, biothesiometry
- Medical subject headings
- Erectile Dysfunction, Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiothesiometryDevice
Also called Neurothesiometer
Biothesiometry using Biothesiometer (Bio Medical Instrument Co, Ohio, United States of America), placed on glans penis and second finger of nondominant hand.
Transcutaneous blood gas monitoringDevice
Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.
Cycling on a home trainerDevice
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.
Bike FittingDevice
Setting standardized posture of the rider on the bike using Retül technology (Retül, Specialized Bicycle Components Inc., Boulder, Colorado, United States of America)
Heart rate monitoringDevice
Measuring heart rate using Wahoo TICKR chest strap (Wahoo Fitness LLC, Atlanta, Georgia, United States of America)
Velomotrik smart cover BTDevice
Saddle pressure measurement, mean and max saddle pressure, saddle pressure distribution. (Velometrik GmbH, Neukieritzsch, Germany).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Order of saddle testing: Joyseat saddle - Specialized Power saddle - Fizik Tundra M5 saddle Receives: Device: Biothesiometry; Device: Transcutaneous blood gas monitoring; Device: Cycling on a home trainer; Device: Bike Fitting; Device: Heart rate monitoring; Device: Velomotrik smart cover BT |
| Group 2 | Active comparator | Order of saddle testing: Joyseat saddle - Fizik Tundra M5 saddle - Specialized Power saddle Receives: Device: Biothesiometry; Device: Transcutaneous blood gas monitoring; Device: Cycling on a home trainer; Device: Bike Fitting; Device: Heart rate monitoring; Device: Velomotrik smart cover BT |
| Group 3 | Active comparator | Order of saddle testing: Specialized Power saddle - Fizik Tundra M5 saddle - Joyseat saddle Receives: Device: Biothesiometry; Device: Transcutaneous blood gas monitoring; Device: Cycling on a home trainer; Device: Bike Fitting; Device: Heart rate monitoring; Device: Velomotrik smart cover BT |
| Group 4 | Active comparator | Order of saddle testing: Specialized Power saddle - Joyseat saddle - Fizik Tundra M5 saddle Receives: Device: Biothesiometry; Device: Transcutaneous blood gas monitoring; Device: Cycling on a home trainer; Device: Bike Fitting; Device: Heart rate monitoring; Device: Velomotrik smart cover BT |
| Group 5 | Active comparator | Order of saddle testing: Fizik Tundra M5 saddle - Joyseat saddle - Specialized Power saddle Receives: Device: Biothesiometry; Device: Transcutaneous blood gas monitoring; Device: Cycling on a home trainer; Device: Bike Fitting; Device: Heart rate monitoring; Device: Velomotrik smart cover BT |
| Group 6 | Active comparator | Order of saddle testing: Fizik Tundra M5 saddle - Specialized Power saddle - Joyseat saddle Receives: Device: Biothesiometry; Device: Transcutaneous blood gas monitoring; Device: Cycling on a home trainer; Device: Bike Fitting; Device: Heart rate monitoring; Device: Velomotrik smart cover BT |
What is being measured
The primary outcome is the main question the study is designed to answer.
pO2_change_point
Parameter pO2_change_point is the time from start of TcPO₂ measurement to the identified change point, determined within the 50-400 s interval as the transition between the fitted initial linear trend and the subsequent linear trend in TcPO₂
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_change_point
Parameter pCO2_change_point is the time from start of TcPCO₂ measurement to the identified change point, determined within the 200-550 s interval as the transition between the fitted initial linear trend and the subsequent linear trend in TcPCO₂
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
Secondary outcomes (24)
pO2_start
The value of the fitted trend at time 0 in TcPO₂ measurement.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_decline
The slope of the fitted trend of decline in TcPO₂ after initial 20s.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_end
The slope of the second fitted trend after pO2_change_point in TcPO₂ measurement.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_part1
The average value of TcPO₂ measurements in the first 20 s segment.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_part2
The average value of TcPO₂ measurements for the second segment, from 21 s to the trend pO2_change_point.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_part3
The average value of TcPO₂ measurements for the third segment after pO2_change_point.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_mean
The average of all TcPO₂ measurements in one interval.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_median
The median of all TcPO₂ measurements in one interval.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_start
The value of the fitted trend at time 0 in TcPCO₂ measurement.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_incline
The slope of the fitted trend of increase in TcPCO₂ in the first segment before pCO2_change_point
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_end
The slope of the fitted trend in TcPCO₂ in the second segment after pCO2_change_point.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_part1
The average value of TcPCO₂ measurements in the first segment before pCO2_change_point.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_part2
The average value of TcPCO₂ measurements in the second segment after pCO2_change_point.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_mean
The average of all TcPCO₂ measurements in one interval.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_median
The median of all TcPCO₂ measurements in one interval.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
logratio_11_8
The logarithmic value of the ratio of the load on the front and rear parts of the saddle, where the saddle is divided in a ratio of 11:8 longitudinally.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
PERI
Pressure value in the predefined perineal area with an area of 44 cm² in front of the ischial tuberosity maxima.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
modPSRG/F
Vibrotactile thresholds were measured at the volar distal phalanx of the non-dominant hand and midline of the glans penis. The probe was placed perpendicular without additional pressure. Voltage was gradually increased until the first sensation was reported, then increased further and slowly decreased until sensation was lost. Upper and lower thresholds were recorded three times per site, averaged, and used to calculate the modified Penile Sensitivity Ratio Glans/Finger via the following formula. Average of the three glans upper+lower threshold values divided by the average of the three finger upper+lower threshold values.
Measured: A baseline testing at the beginning of the testing protocol lasting around 5 minutes.
CVdrift
The percentage of cardiovascular drift calculated as a ratio between average Power and average Heart Rate between the first and second part of the 10-minute interval.
((P1/HR1) - (P2/HR2))/(P1/HR1) * 100 where: P1 - Average Power from first half part of the workout P2 - Average Power from second half part of the workout HR1 - Average Heart Rate from first half part of the workout HR2 - Average Heart Rate from second half part of the workout
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
Bike Fit parameters
Bike Fit values as recorded by Retül V7 System.
KOPS - Knee Over Pedal Spindle - The fore/aft offset of the knee marker relative to the pedal spindle at 3 o'clock in the pedal stroke (90° in the downstroke) MKF - Maximum Knee Flexion - Maximum flexion of the knee joint at any point in the pedal stroke defined by the line connecting hip and knee markers and the line connecting knee and ankle markers MKE - Maximum Knee Extension - Maximum extension of the knee joint at any point in the pedal stroke defined by the line connecting hip and knee markers and the line connecting knee and ankle markers SAW - Shoulder Angle to Wrist - The angle of the shoulder joint defined as the angle at intersection of the line connecting hip and shoulder markers, and the line connecting wrist and shoulder markers BA - Back Angle - The angle of the back relative to the horizon defined by the hip and shoulder marker
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_start
Mean of first 12s of TcPO₂ measurements in each 10 minute interval.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_end
Mean of last 12s of TcPO₂ measurements in each 10 minute interval.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_start
Mean of first 12s of TcPCO₂ measurements in each 10 minute interval.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_end
Mean of last 12s of TcPCO₂ measurements in each 10 minute interval.
Measured: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start21 Apr 2023
- Primary completion14 May 2023
- Study completion14 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Model description
- This study employed a randomized, within-subject, crossover design with counterbalancing to evaluate the effects of three different cycling saddles on transcutaneous penile oxygen (TcPO₂) and carbon dioxide (TcPCO₂) pressures in elite male cyclists. Participants cycled for 10 minutes on each saddle on a stationary trainer, with 5 minute rest intervals between conditions. To minimize potential order effects, participants were randomly assigned to one of six saddle-order sequences.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milan Martínek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Milan Martínek, Charles University, Czech Republic
- Investigators
- Milan Martínek, Mgr., Ph.D., Principal investigator, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887193
- Sponsor's protocol ID
- CharlesUCR - EC-SADDLE
- Other IDs
- UK FTVS 002/2023
- Acronym
- EC-SADDLE
- Status last verified
- Dec 2025
- First submitted
- 21 Apr 2023
- Last updated
- 30 Dec 2025
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Contemporary Cycling Saddle Designs on Penile Transcutaneus Oxygen and Carbon Dioxide Levels in Elite Road Cyclists Riding on a Stationary Trainer
- ClinicalTrials.gov ID
- NCT05887193
- Acronym / sponsor ID
- EC-SADDLE / CharlesUCR - EC-SADDLE
- Keywords
- saddle, pressure, bicycling, erectile dysfunction, hypesthesia, transcutaneous blood gas monitoring, bike fit, biothesiometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Milan MartínekUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 14 May 2023 (actual)
- Study completion
- 14 May 2023 (actual)
- First posted
- 2 Jun 2023 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This study employed a randomized, within-subject, crossover design with counterbalancing to evaluate the effects of three different cycling saddles on transcutaneous penile oxygen (TcPO₂) and carbon dioxide (TcPCO₂) pressures in elite male cyclists. Participants cycled for 10 minutes on each saddle on a stationary trainer, with 5 minute rest intervals between conditions. To minimize potential order effects, participants were randomly assigned to one of six saddle-order sequences.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: Biothesiometry, Device: Transcutaneous blood gas monitoring, Device: Cycling on a home trainer, Device: Bike Fitting, Device: Heart rate monitoring, Device: Velomotrik smart cover BTOrder of saddle testing: Joyseat saddle - Specialized Power saddle - Fizik Tundra M5 saddle |
| Group 2 | Active comparator | Device: Biothesiometry, Device: Transcutaneous blood gas monitoring, Device: Cycling on a home trainer, Device: Bike Fitting, Device: Heart rate monitoring, Device: Velomotrik smart cover BTOrder of saddle testing: Joyseat saddle - Fizik Tundra M5 saddle - Specialized Power saddle |
| Group 3 | Active comparator | Device: Biothesiometry, Device: Transcutaneous blood gas monitoring, Device: Cycling on a home trainer, Device: Bike Fitting, Device: Heart rate monitoring, Device: Velomotrik smart cover BTOrder of saddle testing: Specialized Power saddle - Fizik Tundra M5 saddle - Joyseat saddle |
| Group 4 | Active comparator | Device: Biothesiometry, Device: Transcutaneous blood gas monitoring, Device: Cycling on a home trainer, Device: Bike Fitting, Device: Heart rate monitoring, Device: Velomotrik smart cover BTOrder of saddle testing: Specialized Power saddle - Joyseat saddle - Fizik Tundra M5 saddle |
| Group 5 | Active comparator | Device: Biothesiometry, Device: Transcutaneous blood gas monitoring, Device: Cycling on a home trainer, Device: Bike Fitting, Device: Heart rate monitoring, Device: Velomotrik smart cover BTOrder of saddle testing: Fizik Tundra M5 saddle - Joyseat saddle - Specialized Power saddle |
| Group 6 | Active comparator | Device: Biothesiometry, Device: Transcutaneous blood gas monitoring, Device: Cycling on a home trainer, Device: Bike Fitting, Device: Heart rate monitoring, Device: Velomotrik smart cover BTOrder of saddle testing: Fizik Tundra M5 saddle - Specialized Power saddle - Joyseat saddle |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- gender: male, age: 18-45 years, discipline: road cycling, annual mileage: more than 14000 km (Tier 3-4)
Key exclusion criteria (1 listed)
- Participants other than male, diagnosed with erectile dysfunction, acute or chronic back pain, acute (especially infectious) illness or injury, and in recovery from illness or injury are not eligible for inclusion in the research
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 |
|---|---|---|
| BiothesiometryAlso: NeurothesiometerBiothesiometry using Biothesiometer (Bio Medical Instrument Co, Ohio, United States of America), placed on glans penis and second finger of nondominant hand. | Device | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Transcutaneous blood gas monitoringPenile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis. | Device | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Cycling 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. | Device | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Bike FittingSetting standardized posture of the rider on the bike using Retül technology (Retül, Specialized Bicycle Components Inc., Boulder, Colorado, United States of America) | Device | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Heart rate monitoringMeasuring heart rate using Wahoo TICKR chest strap (Wahoo Fitness LLC, Atlanta, Georgia, United States of America) | Device | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Velomotrik smart cover BTSaddle pressure measurement, mean and max saddle pressure, saddle pressure distribution. (Velometrik GmbH, Neukieritzsch, Germany). | Device | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
pO2_change_point
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
Parameter pO2_change_point is the time from start of TcPO₂ measurement to the identified change point, determined within the 50-400 s interval as the transition between the fitted initial linear trend and the subsequent linear trend in TcPO₂
pCO2_change_point
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
Parameter pCO2_change_point is the time from start of TcPCO₂ measurement to the identified change point, determined within the 200-550 s interval as the transition between the fitted initial linear trend and the subsequent linear trend in TcPCO₂
24 secondary outcomes
pO2_start
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_decline
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_end
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_part1
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_part2
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_part3
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_mean
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_median
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_start
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_incline
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_end
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_part1
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_part2
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_mean
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_median
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
logratio_11_8
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
PERI
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
modPSRG/F
Time frame: A baseline testing at the beginning of the testing protocol lasting around 5 minutes.
CVdrift
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
Bike Fit parameters
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_start
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_end
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_start
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_end
Time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
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 30 Dec 2025.
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Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Milan Martínek, Mgr., Ph.D. principal investigator
Charles University, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biothesiometry, Transcutaneous blood gas monitoring and Cycling on a home trainer in people with Healthy and Cyclists, run by Milan Martínek at 1 site in Czechia.
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 1 inclusion and 1 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 30 Dec 2025. 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 Czechia. 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?
pO2_change_point (time frame: During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).). The study lists 2 primary outcomes in all. 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 30 Dec 2025.