Clinical trial NCT05692947: The Validity of CORE Sensor in Heat Training for Male and Female Endurance Athletes
Official title: The Validity of CORE Sensor in Heat Training for Male and Female Endurance Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temperature Change, Body
Keywords: Exercise
Heat acclimation
Core temperature
Heat loading
Heat stress
Thermoregulation
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each athlete will be asked to exercise for 45 minutes in a hot/dry condition (38 degrees Celsius and 10-20% relative humidity) and a hot/humid condition (28 degrees Celsius and 80-100% relative humidity). Experimental sessions will occur at least seven days apart and participants will be randomly assigned to which condition they experience first.
Primary purpose: BASIC_SCIENCE

Brief summary: This study is investigating the efficacy of CORE™ devices in calculating core body temperature in athletes under varying environmental conditions.

Detailed description: As athletes exercise, their core body temperature rises, which can affect their performance. Additionally, repeated mild to moderate heat stress, heat acclimation, can be used to improve exercise tolerance and performance. Thus, an athlete can gain performance benefits through monitoring their heat loading while training. The aim of this study is to compare the CORE™ body temperatures recorded during exercise in two different environmental conditions in which the investigators will get a separation of core temperature and skin temperature. The investigators will accomplish this by recruiting trained and elite athletes, ages 18-59, to participate in two exercise sessions in the heat at low (10-20%) and high (80-100%) relative humidity. The investigators will compare the CORE™ temperature estimates against an FDA approved ingestible temperature monitoring device to assess the accuracy of the CORE™ devices.

Eligibility criteria: Inclusion Criteria:

* Highly trained or elite athlete
* Nonsmokers
* Able to read and speak English
* No underlying cardiovascular limitations

Exclusion Criteria:

* Currently or previously a habitual smoker (nicotine/cannabis)
* Pregnant, breast feeding, trying to conceive, undergoing treatment to increase sperm count
* Those taking medications that affect cardiovascular function, with the exception of oral contraceptives
* History of stroke, clotting disorders or venous thrombosis
* A history of heat illness or heat injury
* History of obstructive diseases of the gastrointestinal tract including diverticulosis, diverticulitis, inflammatory bowel disease, peptic ulcer disease, Chron's disease, ulcerative colitis, or previous GI surgery

Primary outcomes:
measure: Ability to accurately estimate core body temperature
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Bowerman Sports Science Center at the University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Christopher T Minson, PhD
role: PRINCIPAL_INVESTIGATOR
References: