Back to resultsCold Water Immersion Stirring in Hyperthermic Individuals
Primary Purpose
Hyperthermia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water Stirring
No Water Stirring
Sponsored by
About this trial
This is an interventional treatment trial for Hyperthermia
Eligibility Criteria
Inclusion Criteria:
- 18-39 y old men and women
- Self-reported to be healthy
- Currently completes aerobic exercise at least 30 minutes a day, at least 2 days per week
Exclusion Criteria:
- History of any cardiovascular, neurologic, renal, or metabolic disease
- History of any contraindications on the CoreTemp contraindications and warnings document
- Current tobacco use or regular use within the last 2 years
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
- History of exertional heat stroke
- Currently pregnant or breastfeeding
- Inability to follow the rules of the protocols or understand the consent form
Sites / Locations
- Center for Research and Exercise in Special Environments
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Water stirring
No water stirring
Arm Description
Outcomes
Primary Outcome Measures
Cooling rate
The core temperature cooling rate
Secondary Outcome Measures
Full Information
NCT ID
NCT04613843
First Posted
October 30, 2020
Last Updated
July 22, 2022
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT04613843
Brief Title
Cold Water Immersion Stirring in Hyperthermic Individuals
Official Title
Cold Water Immersion Stirring in Hyperthermic Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The best way to cool a very hot person is using cold water immersion, however, the optimization of this technique has not been established. The goal of this study is to determine differences in cooling rates among two types of cold water immersion and passive cooling following immersion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, counterbalanced, crossover design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Water stirring
Arm Type
Active Comparator
Arm Title
No water stirring
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Water Stirring
Intervention Description
Following an active heating protocol, the cooling intervention includes vigorous water stirring throughout cold water immersion.
Intervention Type
Other
Intervention Name(s)
No Water Stirring
Intervention Description
Following an active heating protocol, the cooling intervention includes no water stirring throughout cold water immersion.
Primary Outcome Measure Information:
Title
Cooling rate
Description
The core temperature cooling rate
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-39 y old men and women
Self-reported to be healthy
Currently completes aerobic exercise at least 30 minutes a day, at least 2 days per week
Exclusion Criteria:
History of any cardiovascular, neurologic, renal, or metabolic disease
History of any contraindications on the CoreTemp contraindications and warnings document
Current tobacco use or regular use within the last 2 years
Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
History of exertional heat stroke
Currently pregnant or breastfeeding
Inability to follow the rules of the protocols or understand the consent form
Facility Information:
Facility Name
Center for Research and Exercise in Special Environments
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will be made available upon written request.
Learn more about this trial
Cold Water Immersion Stirring in Hyperthermic Individuals
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