WithdrawnNot Applicable

Cryo Pack Cooling After Exercise-induced Hyperthermia

Stopped: The funding was never received and the study was terminated in the IRB

0Started 2021-02-01

Plain-language summary

This research study aims to examine whether Cryo Cooling packs reduce thermal and cardiovascular strain after exercise-induced hyperthermia compared to a commercially available ice pack. Secondly, the effect of Cryo Cooling packs on cognitive and exercise performance will be examined. There is no current research examining the efficacy of Cryo Cooling packs in hyperthermic individuals and this information will be helpful to establish whether Cryo Cooling Packs can be used for performance enhancement or to prevent heat illness.

Who can participate

Age range

18 Years – 30 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between the ages of 18-30 years * been cleared by the medical monitor for this study Exclusion Criteria: * 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 * 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) * Are a female * Have a history of heat related illness * Throat or gastroesophageal diseases including gastroesophageal reflux disease (aka, GERD) or difficulty swallowing

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Rectal Temperature

Timeframe: Measured continuously for 2-3 hours during exercise and cooling period

Change in Esophageal Temperature

Timeframe: Measured continuously for 2-3 hours during exercise and cooling period

Change in Heart rate

Timeframe: Measured continuously for 2-3 hours during exercise and cooling period

Change in Skin Temperature

Timeframe: Measured continuously for 2-3 hours during exercise and cooling period

Change in Rating of Perceived Exertion

Timeframe: Collected every 5 minutes during 2-3 hour exercise and cool down period.

Change in Perception of Fatigue

Timeframe: Collected every 5 minutes during 2-3 hour exercise and cool down period.

Change in Perception of Thirst

Timeframe: Collected every 5 minutes during 2-3 hour exercise and cool down period.

Trial details

NCT IDNCT04257266

SponsorUniversity of Connecticut

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-15

View on ClinicalTrials.gov More Hyperthermia trials

Plain-language summary

Who can participate

Age range

18 Years – 30 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Rectal Temperature

Timeframe: Measured continuously for 2-3 hours during exercise and cooling period

Change in Esophageal Temperature

Timeframe: Measured continuously for 2-3 hours during exercise and cooling period

Change in Heart rate

Timeframe: Measured continuously for 2-3 hours during exercise and cooling period

Change in Skin Temperature

Timeframe: Measured continuously for 2-3 hours during exercise and cooling period

Change in Rating of Perceived Exertion

Timeframe: Collected every 5 minutes during 2-3 hour exercise and cool down period.

Change in Perception of Fatigue

Timeframe: Collected every 5 minutes during 2-3 hour exercise and cool down period.

Change in Perception of Thirst

Timeframe: Collected every 5 minutes during 2-3 hour exercise and cool down period.