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

University of Oregon logo

University of Oregon

Status

Completed

Conditions

Temperature Change, Body

Treatments

Device: Core body temperature device

Study type

Interventional

Funder types

Other

Identifiers

NCT05692947
STUDY00000607

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Hot/Dry
Experimental group
Description:
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).
Treatment:
Device: Core body temperature device
Hot/Humid
Experimental group
Description:
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).
Treatment:
Device: Core body temperature device

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Karen W Needham, BS; Christopher T Minson, PhD

Data sourced from clinicaltrials.gov

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