Status:
COMPLETED
Physiological and Thermoregulatory Responses of Body Cooling During Cycling in a Hot Environment
Lead Sponsor:
University of Connecticut
Collaborating Sponsors:
BHSAI
Conditions:
Hyperthermia
Eligibility:
MALE
18-28 years
Phase:
NA
Brief Summary
BHSAI is developing a computational system that provides early alerts of a rise in core body temperature to help reduce the risk of heat injury in the field and during training. The goal of the body t...
Detailed Description
Design The study will be completed in the following timeline: Visit 1: Baseline and VO2max Testing Vist 2: Metabolic Heat Production Visit Visit 3-6: Trial 1, 2 ,3, 4 Visit specific information i...
Eligibility Criteria
Inclusion
- Cisgender man between the ages of 18-28 years
- been cleared by the medical monitor for this study
- VO2max \> 45ml/kg/min
- Aerobically active (at least 30 minutes of aerobic exercise 4-5 days per week)
Exclusion
- Have a current musculoskeletal injury that would limit their physical activity or preclude the participant from walking, jogging, running, sprinting, or cutting.
- Chronic health problems that affect your ability to thermoregulate (disorders affecting the liver, kidneys or the ability to sweat normally)
- Fever or current illness at the time of testing
- History of cardiovascular, metabolic, or respiratory disease
- A family member died for no apparent reason, had a heart attack, died from heart problems, or sudden death before the age of 50
- Current musculoskeletal injury that limits their physical activity
- Currently taking a medication that is known to influence body temperature (amphetamines, antihypertensives, anticholinergics, acetaminophen, diuretics, NSAIDs, aspirin)
- Identify as cisgender woman, transgender man or transgender woman. Cisgender women, Transgender men, and transgender women are excluded from the current study because the sponsor of the study has requested that this testing be done in physically active cisgender males. It is assumed that they either currently have data on women or transgender women/men to compare this to or have a strategic initiative from a marketing or business perspective that only involves cisgender men.
- Have a history of heat related illness
- Throat or gastroesophageal diseases including gastroesophageal reflux disease (aka, GERD) or difficulty swallowing
- Have any allergies or adverse reactions to the cold (e.g. Cold Uticaria, Raynauds Phenomenon/Disease, or Cryoglobulinanemia)
Key Trial Info
Start Date :
April 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04715711
Start Date
April 2 2021
End Date
July 19 2021
Last Update
August 3 2021
Active Locations (1)
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1
Korey Stringer Institute, University of Connecticut
Storrs, Connecticut, United States, 06269