Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists.
CYSU
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2024
CompletedStudy Start
First participant enrolled
February 19, 2024
CompletedFirst Posted
Study publicly available on registry
March 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2024
CompletedJune 24, 2024
January 1, 2024
2 months
February 15, 2024
June 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sweat
The amount of sweat will be measured by a sensor placed on the back.
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 (7)
Microcapillary Blood
Change of baseline rate of sweet rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Heart Rate
Changes of heart rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Fatigue
Change of fatigue in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Temperature on the forehead
Changes in Temperature on the forehead in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
Temperature in the ear
Changes in Temperature in the ear in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)
- +2 more secondary outcomes
Study Arms (6)
22 degrees, 40% humidity and 50% intensity
EXPERIMENTALThe 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.
35 degrees, 40% humidity and 50% intensity
EXPERIMENTALThe 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.
35 degrees, 65% humidity and 50% intensity
EXPERIMENTALThe 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.
22 degrees, 40% humidity and 60% intensity
EXPERIMENTALThe 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.
35 degrees, 40% humidity and 60% intensity
EXPERIMENTALThe 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.
35 degrees, 65% humidity and 60% intensity
EXPERIMENTALThe 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.
Interventions
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.
The performance test will be carried out in a room conditioned to a temperature of 22º.
The performance test will be carried out in a room conditioned to 40% humidity.
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.
The performance test will be carried out in a room conditioned to a temperature of 35º.
The performance test will be carried out in a room conditioned to 65% humidity.
Eligibility Criteria
You may qualify if:
- Male cyclists with more than two years of cycling experience.
- Perform tests without fatigue.
- Road bike training at least twice a week.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catholic University of Murcia
Murcia, 30107, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 15, 2024
First Posted
March 13, 2024
Study Start
February 19, 2024
Primary Completion
April 12, 2024
Study Completion
May 20, 2024
Last Updated
June 24, 2024
Record last verified: 2024-01