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

NCT ID: NCT05692947

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2024-06-21

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.

Conditions

Temperature Change, Body

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Core body temperature device

Intervention Type: 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.

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).

Group Type: EXPERIMENTAL

Core body temperature device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

CORE™; CaleraResearch™

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oregon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher T Minson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oregon

Locations

Bowerman Sports Science Center at the University of Oregon

Eugene, Oregon, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00000607

Identifier Type: -

Identifier Source: org_study_id