Clinical trial NCT03643835: Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals
Official title: Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryotherapy Effect
Lead sponsor: University of North Carolina, Greensboro
Sponsor class: OTHER
Collaborators: name: Statim Technologies, LLC
First posted: 2018-08-23
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will complete three trials under three different body cooling conditions/interventions; passive cooling using the body's natural body cooling mechanisms, body cooling using forearm ice towels, and cooling using the investigational thermal rehab machine.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Exertional heat stroke (EHS) is an emergency medical condition that is prevalent in military soldiers, athletes, and laborers. It is diagnosed when the rectal temperature is above 40°C with the presence of central nervous dysfunction (altered mental status). The gold standard method of care for EHS is immediate onsite whole body cooling using cold-water immersion (cooling rates \>0.15°C•min-1), which is reported to have the highest cooling rate. In the treatment of EHS, selecting a cooling modality with a high cooling rate becomes crucial to minimize the time above the critical threshold of body temperature at 40°C to less than 30 minutes for the best chance of survival and to minimize the severity of prognosis. However, in situations where cold water immersion is not feasible (in certain military, firefighter, or other remote settings), other cooling modalities must be available that have a cooling capacity similar to that of cold-water immersion. In this proposed study, the investigators aim to examine the cooling rates of the Polar Breeze® device (developed by Statim Technologies, LLC, Clearwater, FL) compared to rotating ice towels, a cooling method often recommended by sports medicine professionals as an alternative to cold-water immersion, and passive rest in participants with exercise-induced hyperthermia.


Eligibility criteria: Inclusion Criteria:

* male between the ages of 18-35.
* recreationally active (regularly exercise at a minimum of 4-5 times per week for greater than 30 minutes per session)

Exclusion Criteria:

* chronic health problems,
* fever or current illness at the time of testing
* history of cardiovascular, metabolic, or respiratory disease
* current musculoskeletal injury that limits physical activity
* history of exertional heat illness in the past three years.

Primary outcomes:
measure: Change in Internal Body Temperature
timeFrame: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 minutes post onset of cooling
Secondary outcomes:
Other outcomes:
Locations:
city: Greensboro
country: United States
facility: University of North Carolina at Greensboro
state: North Carolina
Study officials:
affiliation: University of North Carolina, Greensboro
name: William M Adams, PhD
role: PRINCIPAL_INVESTIGATOR
References: