CClinicalTrials.gg
CompletedNCT06308432CYSUUpdated Jun 24, 2024

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

An interventional study of Low intensity and Low temperature in Sweat, sponsored by Universidad Católica San Antonio de Murcia. Completed at 1 site in Spain. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-24.

Sponsored by Universidad Católica San Antonio de Murcia · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Sweat

Keywords

  • Cyclist
  • Performance
  • Temperature
  • Humidity
03

In context

Lead sponsor

Universidad Católica San Antonio de Murcia is the lead sponsor of 132 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
12 participants (actual)

Study arms

  • 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 · Other: Low temperature · Other: Low 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 · Other: Low Humidity · Other: High temperature

  • 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 · Other: High temperature · Other: High 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 · Other: Low Humidity · Other: High intensity

  • 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 · Other: High intensity · Other: High temperature

  • 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 intensity · Other: High temperature · Other: High humidity

Interventions

  • OtherLow 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.

  • OtherLow temperature

    The performance test will be carried out in a room conditioned to a temperature of 22º.

  • OtherLow Humidity

    The performance test will be carried out in a room conditioned to 40% humidity.

  • OtherHigh 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.

  • OtherHigh temperature

    The performance test will be carried out in a room conditioned to a temperature of 35º.

  • OtherHigh humidity

    The performance test will be carried out in a room conditioned to 65% humidity.

06

What researchers measure

Primary outcomes

  1. Sweat

    The amount of sweat will be measured by a sensor placed on the back.

    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)

Secondary outcomes

  1. 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.

    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)

  2. Heart Rate

    The heart rate will be evaluated by means of a heart rate strap.

    Time frame: Changes of heart rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)

  3. Fatigue

    Rate of perceived exertion using Borg scale. En esta escala 0 representa nada fatigado y el 10 esfuerzo máximo.

    Time frame: Change of fatigue in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)

  4. Temperature on the forehead

    The temperature will be measured by an infrared thermometer.

    Time frame: Changes in Temperature on the forehead in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)

  5. Temperature in the ear

    The temperature will be measured by ear thermometer.

    Time frame: Changes in Temperature in the ear in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)

  6. Sleep efficiency

    Measured by accelerometry, with Actigraph wGT3X-BT

    Time frame: Changes in the sleep efficiency in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)

  7. Karolinska drowsiness scale

    Measured by Karolinska test

    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)

07

Study locations

1 site
  • Catholic University of Murcia
    Murcia, 30107, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06308432
Lead sponsor
Universidad Católica San Antonio de Murcia
Responsible party
Francisco Javier López Román (Principal Investigator, Universidad Católica San Antonio de Murcia) — Principal investigator
First posted
Mar 13, 2024
Start date
Feb 19, 2024
Primary completion
Apr 12, 2024
Completion
May 20, 2024
Last update
Jun 24, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion