Clinical trial NCT06308432: Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists.
Official title: Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sweat
Keywords: Cyclist
Performance
Temperature
Humidity
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sweat
timeFrame: Change of baseline rate of sweet rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Secondary outcomes:
measure: Microcapillary Blood
timeFrame: Change of baseline rate of sweet rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
measure: Heart Rate
timeFrame: Changes of heart rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
measure: Fatigue
timeFrame: Change of fatigue in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
measure: Temperature on the forehead
timeFrame: Changes in Temperature on the forehead in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
measure: Temperature in the ear
timeFrame: Changes in Temperature in the ear in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
measure: Sleep efficiency
timeFrame: Changes in the sleep efficiency in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
measure: Karolinska drowsiness scale
timeFrame: It will be measured the day after in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: