The Validity of CORE Sensor in Heat Training for Male and Female Endurance Athletes

Not Applicable

Completed

• Conditions: Temperature Change, Body
• Interventions: Device: Core body temperature device

• Registration Number: NCT05692947
• Lead Sponsor: University of Oregon

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.

Study Timeline

• Study First Submitted: 2022-09-12
• Study Start: 2022-09-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-20
• Primary Completion: 2024-06-21
• Study Completion: 2024-06-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hot/Humid	Core body temperature device	Core body temperature, skin temperature, heart rate, and heat perceptions will be collected from elite athletes while running or cycling for 45 minutes in the heat at high humidity (28 degrees Celsius with 80-100% relative humidity).
Hot/Dry	Core body temperature device	Core body temperature, skin temperature, heart rate, and heat perceptions will be collected from elite athletes while running or cycling for 45 minutes in the heat at low humidity (38 degrees Celsius with 10-20% relative humidity).

Primary Outcome Measures

Name	Time	Method
Ability to accurately estimate core body temperature	30 minutes	The CORE and CaleraResearch devices estimate core body temperature using single-site skin temperature and heartrate as data inputs for their proprietary algorithm. This calculated temperature will be assessed against actual core body temperature, measured with an FDA approved, ingestible, temperature-sensing telemetry pill.

Trial Locations

Locations (1)

Bowerman Sports Science Center at the University of Oregon; 🇺🇸 Eugene, Oregon, United States