Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists. (CYSU)

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.

Study Overview

• Status: Recruiting
• Conditions: Sweat
• Intervention / Treatment: Other: Low intensity; Other: Low temperature; Other: Low Humidity; Other: High temperature; Other: High humidity; Other: High intensity

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Recruiting
    • Catholic University of Murcia
    • Contact: Fco Javier López Román; Phone Number: 968278523; Email: jlroman@ucam.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 22 degrees, 40% humidity and 50% intensity; The room in which the 30-minute test will be performed will be at 22 degrees Celsius and 40% humidity. The subject should perform the test at 50% of the power at which he reached his VO2max.	Other: Low intensity; The subject will perform the 30-minute test at an intensity of 50% of the power at which he/she has reached his/her VO2max.; Other: Low temperature; The performance test will be carried out in a room conditioned to a temperature of 22º.; Other: Low Humidity; The performance test will be carried out in a room conditioned to 40% humidity.
Experimental: 35 degrees, 40% humidity and 50% intensity; The room in which the 30-minute test will be performed will be at 35 degrees Celsius and 40% humidity. The subject should perform the test at 50% of the power at which he reached his VO2max.	Other: Low intensity; The subject will perform the 30-minute test at an intensity of 50% of the power at which he/she has reached his/her VO2max.; Other: Low Humidity; The performance test will be carried out in a room conditioned to 40% humidity.; Other: High temperature; The performance test will be carried out in a room conditioned to a temperature of 35º.
Experimental: 35 degrees, 65% humidity and 50% intensity; The room in which the 30-minute test will be performed will be at 35 degrees Celsius and 65% humidity. The subject should perform the test at 50% of the power at which he reached his VO2max.	Other: Low intensity; The subject will perform the 30-minute test at an intensity of 50% of the power at which he/she has reached his/her VO2max.; Other: High temperature; The performance test will be carried out in a room conditioned to a temperature of 35º.; Other: High humidity; The performance test will be carried out in a room conditioned to 65% humidity.
Experimental: 22 degrees, 40% humidity and 60% intensity; The room in which the 30-minute test will be performed will be at 22 degrees Celsius and 40% humidity. The subject should perform the test at 60% of the power at which he reached his VO2max.	Other: Low temperature; The performance test will be carried out in a room conditioned to a temperature of 22º.; Other: Low Humidity; The performance test will be carried out in a room conditioned to 40% humidity.; Other: High intensity; The subject will perform the 30-minute test at an intensity of 60% of the power at which he/she has reached his/her VO2max.
Experimental: 35 degrees, 40% humidity and 60% intensity; The room in which the 30-minute test will be performed will be at 35 degrees Celsius and 40% humidity. The subject should perform the test at 60% of the power at which he reached his VO2max.	Other: Low Humidity; The performance test will be carried out in a room conditioned to 40% humidity.; Other: High temperature; The performance test will be carried out in a room conditioned to a temperature of 35º.; Other: High intensity; The subject will perform the 30-minute test at an intensity of 60% of the power at which he/she has reached his/her VO2max.
Experimental: 35 degrees, 65% humidity and 60% intensity; The room in which the 30-minute test will be performed will be at 35 degrees Celsius and 65% humidity. The subject should perform the test at 60% of the power at which he reached his VO2max.	Other: High temperature; The performance test will be carried out in a room conditioned to a temperature of 35º.; Other: High humidity; The performance test will be carried out in a room conditioned to 65% humidity.; Other: High intensity; The subject will perform the 30-minute test at an intensity of 60% of the power at which he/she has reached his/her VO2max.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sweat	The amount of sweat will be measured by a sensor placed on the back.	It will be evaluated in each of the interventions carried out during the study.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microcapillary Blood	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.	It will be evaluated in each of the interventions carried out during the study.
Heart Rate	The heart rate will be evaluated by means of a heart rate strap.	It will be evaluated in each of the interventions carried out during the study.
Fatigue	Rate of perceived exertion using Borg scale. En esta escala 0 representa nada fatigado y el 10 esfuerzo máximo.	It will be evaluated in each of the interventions carried out during the study.
Temperature on the forehead	The temperature will be measured by an infrared thermometer.	It will be evaluated in each of the interventions carried out during the study.
Temperature in the ear	The temperature will be measured by ear thermometer.	It will be evaluated in each of the interventions carried out during the study.
Sleep efficiency	Measured by accelerometry, with Actigraph wGT3X-BT	It will be measured during 4 working days in the first visit. Besides, each night after each visit
Karolinska drowsiness scale	Measured by Karolinska test	It will be measured the day after each visit to the laboratory.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): April 12, 2024
• Study Completion (Estimated): May 20, 2024

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Performance; Temperature; Humidity; Cyclist
• Other Study ID Numbers: UCAMCFE-00036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No