Cold Water Immersion Stirring in Hyperthermic Individuals

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.

Study Overview

• Status: Completed
• Conditions: Hyperthermia
• Intervention / Treatment: Other: Water Stirring; Other: No Water Stirring

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • Center for Research and Exercise in Special Environments

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Water stirring	Other: Water Stirring; Following an active heating protocol, the cooling intervention includes vigorous water stirring throughout cold water immersion.
Experimental: No water stirring	Other: No Water Stirring; Following an active heating protocol, the cooling intervention includes no water stirring throughout cold water immersion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cooling rate	The core temperature cooling rate	20 minutes

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia
• Other Study ID Numbers: STUDY00003720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will be made available upon written request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No