Cold Water Immersion Stirring in Hyperthermic Individuals | NCT04613843

Studies
Cold Water Immersion Stirring in Hyperthermic Individuals

NCT04613843

Sponsor

State University of New York at Buffalo

Status

Completed

Last Update Posted

Jul 26, 2022Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Hyperthermia

Interventions

Water Stirring
No Water Stirring

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 23, 2019Actual

Primary Completion Date

May 1, 2022Actual

Completion Date

May 1, 2022Actual

First Submitted Date

Oct 30, 2020

First Submission Date that Met QC Criteria

Oct 30, 2020

First Posted Date

Nov 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2022

Last Update Posted Date

Jul 26, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Riana Pryor, Principal Investigator, State University of New York at BuffaloPrincipal Investigator

Lead Sponsor

State University of New York at BuffaloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Water stirring	Active Comparator		Other: Water Stirring
No water stirring	Experimental		Other: No Water Stirring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Water Stirring	Other	Following an active heating protocol, the cooling intervention includes vigorous water stirring throughout cold water immersion.	Water stirring

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Research and Exercise in Special Environments		Buffalo	New York	14214	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data will be made available upon written request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000084462	Hyperthermia

Ancestor Terms

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D018882	Heat Stress Disorders

Browse Leaves

Not provided

Browse Branches

Not provided