Physiological and Thermoregulatory Responses of Body Cooling During Cycling in a Hot Environment

Completed · Not applicable

Conditions studied: Hyperthermia

In brief

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 temperature alerting system is to use it during rest, exercise in the heat and during body cooling. Using this system during cooling will allow healthcare professionals and military personnel monitor core temperature to ensure cooling is effective (and prevent hypothermia). Therefore, the primary purpose of this investigation is to validate a body temperature alerting system using physiological responses that occur during rest, exercise in the heat and during body cooling. Multiple cooling modalities will be validated. This study is expanding on a previous intervention IRB#H20-0010 (BHSAI Cooling Study), but will examine body cooling during more intense exercise and while cycling. We will also examine the effectiveness of each cooling modality (passive cooling, mist-fan cooling, hand/forearm immersion, ice towel) on physiological variables after exercise in the heat.

Key facts

Study ID

NCT04715711

Run by

University of Connecticut

People needed

12

Starts

2021-04-02

Expected to finish

2021-07-19

Last updated by the study team

2021-08-03

Who can join

Age: 18 and older, up to 28. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Korey Stringer Institute, University of Connecticut — Storrs, Connecticut, United States

Full record on ClinicalTrials.gov

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