Catholic University of Murcia
Murcia, 30107, Spain
Completed
NCT Number: NCT06308432
Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists.
Controlled, double-blind, crossover clinical trial with six parallel arms depending on the combination of temperature and humidity (22º and 40% humidity, 35º 40% humidity and 35º and 65% humidity), with two differents intensity, to investigate and validate the physiological use of a sensor in recreational road cyclists.
Completed
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Subjects who meet the inclusion criteria will be recruited to participate in the clinical trial and perform the exercise sessions.
The cyclists in the study will have to make 7 visits to the laboratory. At the first visit, their aerobic performance will be evaluated by an incremental test to exhaustion with gas analysis. And in the next 6 visits they will have to perform a sustained intensity exercise with different environmental conditions according to the combination of temperature, humidity and intensity.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male cyclists with more than two years of cycling experience.
- Perform tests without fatigue.
- Road bike training at least twice a week.
Exclusion criteria
- Participants with chronic illness.
- Have a long-term injury that prevents you from training in the previous month.
- Inability to understand informed consent.
- Use of diuretics in the month prior to or during the measurement period.
Treatment and study plan
Low Intensity
OtherThe subject will perform the 30-minute test at an intensity of 50% of the power at which he/she has reached his/her VO2max.
Low temperature
OtherThe performance test will be carried out in a room conditioned to a temperature of 22º.
Low Humidity
OtherThe performance test will be carried out in a room conditioned to 40% humidity.
High Intensity
OtherThe subject will perform the 30-minute test at an intensity of 60% of the power at which he/she has reached his/her VO2max.
High temperature
OtherThe performance test will be carried out in a room conditioned to a temperature of 35º.
High humidity
OtherThe performance test will be carried out in a room conditioned to 65% humidity.
Primary outcomes
-
Sweat
Time frame: Change of baseline rate of sweet rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
The amount of sweat will be measured by a sensor placed on the back.
Secondary outcomes
-
Microcapillary Blood
Time frame: Change of baseline rate of sweet rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
By means of a lancet puncture in the thumb of the finger, 70 ml of capillary blood will be extracted.This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood.
-
Heart Rate
Time frame: Changes of heart rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
The heart rate will be evaluated by means of a heart rate strap.
-
Fatigue
Time frame: Change of fatigue in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Rate of perceived exertion using Borg scale. En esta escala 0 representa nada fatigado y el 10 esfuerzo máximo.
-
Temperature on the forehead
Time frame: Changes in Temperature on the forehead in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
The temperature will be measured by an infrared thermometer.
-
Temperature in the ear
Time frame: Changes in Temperature in the ear in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
The temperature will be measured by ear thermometer.
-
Sleep efficiency
Time frame: Changes in the sleep efficiency in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Measured by accelerometry, with Actigraph wGT3X-BT
-
Karolinska drowsiness scale
Time frame: It will be measured the day after in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Measured by Karolinska test
Sponsors and collaborators
Lead sponsor
Universidad Católica San Antonio de Murcia
Other
Registry information
Acronym: CYSU
Important dates
- Study start
- 2024
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Mar 13, 2024
- Registry last updated
- Jun 24, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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