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Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals

Primary Purpose

Cryotherapy Effect

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thermal Rehab Machine
Forearm Ice Towels
Sponsored by
University of North Carolina, Greensboro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Cryotherapy Effect

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of North Carolina at Greensboro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Thermal rehab machine

Forearm Ice Towels

Passive Cooling

Arm Description

Participants, following exercise-induced hyperthermia, will be cooled using a Thermal Rehab Machine (Polar Breeze, Statim Technologies, LLC, Clearwater Florida), which is a micro-environmental air chiller. The device will be placed over the subjects head and through trans pulmonary cooling, will cool the body.

Participants, following exercise-induced hyperthermia, will be cooled using forearm ice towels. Cotton-blend towels will be doused in ice-water and then wrapped around participant's forearms (elbow to wrist). The towels will be rotated (re-wetted) every 2 minutes)

Participants, following exercise-induced hyperthermia, will undergo a period of passive rest to allow the body to cool via natural mechanisms of evaporation of sweat from the skin's surface and convection

Outcomes

Primary Outcome Measures

Change in Internal Body Temperature
The rate at which body temperature is reduced during whole body cooling following exercise-induced hyperthermia.

Secondary Outcome Measures

Full Information

First Posted
August 15, 2018
Last Updated
April 16, 2019
Sponsor
University of North Carolina, Greensboro
Collaborators
Statim Technologies, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03643835
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Greensboro
Collaborators
Statim Technologies, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryotherapy Effect

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thermal rehab machine
Arm Type
Experimental
Arm Description
Participants, following exercise-induced hyperthermia, will be cooled using a Thermal Rehab Machine (Polar Breeze, Statim Technologies, LLC, Clearwater Florida), which is a micro-environmental air chiller. The device will be placed over the subjects head and through trans pulmonary cooling, will cool the body.
Arm Title
Forearm Ice Towels
Arm Type
Active Comparator
Arm Description
Participants, following exercise-induced hyperthermia, will be cooled using forearm ice towels. Cotton-blend towels will be doused in ice-water and then wrapped around participant's forearms (elbow to wrist). The towels will be rotated (re-wetted) every 2 minutes)
Arm Title
Passive Cooling
Arm Type
No Intervention
Arm Description
Participants, following exercise-induced hyperthermia, will undergo a period of passive rest to allow the body to cool via natural mechanisms of evaporation of sweat from the skin's surface and convection
Intervention Type
Device
Intervention Name(s)
Thermal Rehab Machine
Other Intervention Name(s)
Polar Breeze
Intervention Description
The Polar Breeze unit is a microenvironmental air-chiller. That means it is a single-pass air-conditioner capable of cooling external air
Intervention Type
Other
Intervention Name(s)
Forearm Ice Towels
Intervention Description
Towels that are wetted with ice water and wrapped around participants forearms (length of arm from wrist to elbow)
Primary Outcome Measure Information:
Title
Change in Internal Body Temperature
Description
The rate at which body temperature is reduced during whole body cooling following exercise-induced hyperthermia.
Time Frame
0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 minutes post onset of cooling

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William M Adams, PhD
Organizational Affiliation
University of North Carolina, Greensboro
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27412
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals

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