Effects of Contemporary Cycling Saddle Designs on Penile Transcutaneus Oxygen and Carbon Dioxide Levels in Elite Road Cyclists Riding on a Stationary Trainer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- pO2_change_point
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •gender: male, age: 18-45 years, discipline: road cycling, annual mileage: more than 14000 km (Tier 3-4)
排除标准
- •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
研究组 & 干预措施
Group 1
Order of saddle testing: Joyseat saddle - Specialized Power saddle - Fizik Tundra M5 saddle
干预措施: Biothesiometry (Device)
Group 1
Order of saddle testing: Joyseat saddle - Specialized Power saddle - Fizik Tundra M5 saddle
干预措施: Transcutaneous blood gas monitoring (Device)
Group 1
Order of saddle testing: Joyseat saddle - Specialized Power saddle - Fizik Tundra M5 saddle
干预措施: Cycling on a home trainer (Device)
Group 1
Order of saddle testing: Joyseat saddle - Specialized Power saddle - Fizik Tundra M5 saddle
干预措施: Bike Fitting (Device)
Group 1
Order of saddle testing: Joyseat saddle - Specialized Power saddle - Fizik Tundra M5 saddle
干预措施: Heart rate monitoring (Device)
Group 1
Order of saddle testing: Joyseat saddle - Specialized Power saddle - Fizik Tundra M5 saddle
干预措施: Velomotrik smart cover BT (Device)
Group 2
Order of saddle testing: Joyseat saddle - Fizik Tundra M5 saddle - Specialized Power saddle
干预措施: Biothesiometry (Device)
Group 2
Order of saddle testing: Joyseat saddle - Fizik Tundra M5 saddle - Specialized Power saddle
干预措施: Transcutaneous blood gas monitoring (Device)
Group 2
Order of saddle testing: Joyseat saddle - Fizik Tundra M5 saddle - Specialized Power saddle
干预措施: Cycling on a home trainer (Device)
Group 2
Order of saddle testing: Joyseat saddle - Fizik Tundra M5 saddle - Specialized Power saddle
干预措施: Bike Fitting (Device)
Group 2
Order of saddle testing: Joyseat saddle - Fizik Tundra M5 saddle - Specialized Power saddle
干预措施: Heart rate monitoring (Device)
Group 2
Order of saddle testing: Joyseat saddle - Fizik Tundra M5 saddle - Specialized Power saddle
干预措施: Velomotrik smart cover BT (Device)
Group 3
Order of saddle testing: Specialized Power saddle - Fizik Tundra M5 saddle - Joyseat saddle
干预措施: Biothesiometry (Device)
Group 3
Order of saddle testing: Specialized Power saddle - Fizik Tundra M5 saddle - Joyseat saddle
干预措施: Transcutaneous blood gas monitoring (Device)
Group 3
Order of saddle testing: Specialized Power saddle - Fizik Tundra M5 saddle - Joyseat saddle
干预措施: Cycling on a home trainer (Device)
Group 3
Order of saddle testing: Specialized Power saddle - Fizik Tundra M5 saddle - Joyseat saddle
干预措施: Bike Fitting (Device)
Group 3
Order of saddle testing: Specialized Power saddle - Fizik Tundra M5 saddle - Joyseat saddle
干预措施: Heart rate monitoring (Device)
Group 3
Order of saddle testing: Specialized Power saddle - Fizik Tundra M5 saddle - Joyseat saddle
干预措施: Velomotrik smart cover BT (Device)
Group 4
Order of saddle testing: Specialized Power saddle - Joyseat saddle - Fizik Tundra M5 saddle
干预措施: Biothesiometry (Device)
Group 5
Order of saddle testing: Fizik Tundra M5 saddle - Joyseat saddle - Specialized Power saddle
干预措施: Biothesiometry (Device)
Group 4
Order of saddle testing: Specialized Power saddle - Joyseat saddle - Fizik Tundra M5 saddle
干预措施: Transcutaneous blood gas monitoring (Device)
Group 4
Order of saddle testing: Specialized Power saddle - Joyseat saddle - Fizik Tundra M5 saddle
干预措施: Cycling on a home trainer (Device)
Group 4
Order of saddle testing: Specialized Power saddle - Joyseat saddle - Fizik Tundra M5 saddle
干预措施: Bike Fitting (Device)
Group 4
Order of saddle testing: Specialized Power saddle - Joyseat saddle - Fizik Tundra M5 saddle
干预措施: Heart rate monitoring (Device)
Group 4
Order of saddle testing: Specialized Power saddle - Joyseat saddle - Fizik Tundra M5 saddle
干预措施: Velomotrik smart cover BT (Device)
Group 5
Order of saddle testing: Fizik Tundra M5 saddle - Joyseat saddle - Specialized Power saddle
干预措施: Transcutaneous blood gas monitoring (Device)
Group 5
Order of saddle testing: Fizik Tundra M5 saddle - Joyseat saddle - Specialized Power saddle
干预措施: Cycling on a home trainer (Device)
Group 5
Order of saddle testing: Fizik Tundra M5 saddle - Joyseat saddle - Specialized Power saddle
干预措施: Bike Fitting (Device)
Group 5
Order of saddle testing: Fizik Tundra M5 saddle - Joyseat saddle - Specialized Power saddle
干预措施: Heart rate monitoring (Device)
Group 5
Order of saddle testing: Fizik Tundra M5 saddle - Joyseat saddle - Specialized Power saddle
干预措施: Velomotrik smart cover BT (Device)
Group 6
Order of saddle testing: Fizik Tundra M5 saddle - Specialized Power saddle - Joyseat saddle
干预措施: Biothesiometry (Device)
Group 6
Order of saddle testing: Fizik Tundra M5 saddle - Specialized Power saddle - Joyseat saddle
干预措施: Transcutaneous blood gas monitoring (Device)
Group 6
Order of saddle testing: Fizik Tundra M5 saddle - Specialized Power saddle - Joyseat saddle
干预措施: Cycling on a home trainer (Device)
Group 6
Order of saddle testing: Fizik Tundra M5 saddle - Specialized Power saddle - Joyseat saddle
干预措施: Bike Fitting (Device)
Group 6
Order of saddle testing: Fizik Tundra M5 saddle - Specialized Power saddle - Joyseat saddle
干预措施: Heart rate monitoring (Device)
Group 6
Order of saddle testing: Fizik Tundra M5 saddle - Specialized Power saddle - Joyseat saddle
干预措施: Velomotrik smart cover BT (Device)
结局指标
主要结局
pO2_change_point
时间窗: 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
时间窗: 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
次要结局
- pO2_start(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(A baseline testing at the beginning of the testing protocol lasting around 5 minutes.)
- CVdrift(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(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).)
研究者
Milan Martínek
Mgr. Ph.D.
Charles University, Czech Republic