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

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

Study Overview

• Status: Completed
• Conditions: Temperature Change, Body
• Intervention / Treatment: Device: Core body temperature device

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97403
      • Bowerman Sports Science Center at the University of Oregon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hot/Dry; 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).	Device: Core body temperature device; This study is to verify the claims of CORE™ body temperature system to estimate core body temperature from skin temperature and heart rate during exercise under varying environmental conditions. Subjects will ingest a temperature sensing pill and be outfitted with skin temperature sensors, a chest strap heart rate monitor, and the CORE and CaleraResearch devices. Athletes will run or cycle in hot/dry and hot/humid conditions for 45 minutes at an absolute workload of 60% VO2 Max/Peak.; Other Names: CORE™; CaleraResearch™
Experimental: Hot/Humid; 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).	Device: Core body temperature device; This study is to verify the claims of CORE™ body temperature system to estimate core body temperature from skin temperature and heart rate during exercise under varying environmental conditions. Subjects will ingest a temperature sensing pill and be outfitted with skin temperature sensors, a chest strap heart rate monitor, and the CORE and CaleraResearch devices. Athletes will run or cycle in hot/dry and hot/humid conditions for 45 minutes at an absolute workload of 60% VO2 Max/Peak.; Other Names: CORE™; CaleraResearch™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to accurately estimate core body temperature	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.	30 minutes

Collaborators and Investigators

• Sponsor: University of Oregon
• Investigators: Principal Investigator: Christopher T Minson, PhD, University of Oregon

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): June 21, 2024
• Study Completion (Actual): June 21, 2024

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Thermoregulation; Heat stress; Heat acclimation; Core temperature; Heat loading
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Heat Stress Disorders; Body Temperature Changes; Motor Activity
• Other Study ID Numbers: STUDY00000607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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