NCT04613843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 30, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

2.5 years

First QC Date

October 30, 2020

Last Update Submit

July 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cooling rate

    The core temperature cooling rate

    20 minutes

Study Arms (2)

Water stirring

ACTIVE COMPARATOR
Other: Water Stirring

No water stirring

EXPERIMENTAL
Other: No Water Stirring

Interventions

Following an active heating protocol, the cooling intervention includes vigorous water stirring throughout cold water immersion.

Water stirring

Following an active heating protocol, the cooling intervention includes no water stirring throughout cold water immersion.

No water stirring

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Research and Exercise in Special Environments

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized, counterbalanced, crossover design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 3, 2020

Study Start

October 23, 2019

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will be made available upon written request.

Locations