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The Effects of Cold Adaptation on Skin Blood Flow, Hand Function, and Comfort in Healthy Adults

NCT ID: NCT05464758

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-09-13

Brief Summary

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In cold weather environments, blood flow to the extremities is significantly reduced, which severely impairs hand function and induces thermal discomfort. Prolonged or repeated cold exposure elicits an adaptive habituation response that is characterized by blunted skin vasoconstriction and thus may be an effective strategy to improve peripheral perfusion, reduce thermal discomfort, and maintain hand function during cold weather military operations. Since mission conditions often involve low ambient temperatures, countermeasures that reduce cold-induced decrements in hand function and thermal comfort are important to enhance Warfighter readiness in cold weather battlefield environments. The goals of this study are to 1) evaluate the effectiveness of cold habituation in improving skin blood flow, hand function, and thermal comfort during cold exposure and 2) identify the mechanisms that contribute to improvements in skin blood flow following habituation.

Detailed Description

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Participants (n=15, 18-39 yrs) will complete a preliminary cold air exposure (baseline testing) followed by 8 days of repeated cold air exposures with minimal clothing. The cold exposures will be 2 hours in duration and will be conducted in 8°C (46°F) conditions. Before and after the repeated cold exposures, participants will undergo hand function tests, assessments of thermal comfort, and skin blood flow testing.

Conditions

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Cold Exposure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cold habituation

8-day cold habituation

Group Type EXPERIMENTAL

Repeated cold exposure

Intervention Type OTHER

8 consecutive days of exposure to 8°C air for 120 minutes each day

Interventions

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Repeated cold exposure

8 consecutive days of exposure to 8°C air for 120 minutes each day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female, age 18-39
* In good health as determined by OMSO (Office of Medical Support and Oversight)
* Willing to refrain from exercise and caffeinated or alcoholic beverages for 12 hours before each testing session
* Willing to refrain from smoking or tobacco use 8 hours before each testing session

Exclusion Criteria

* History of cold injuries of any severity (e.g., frostbite, trench foot, chilblains).
* Raynaud's syndrome.
* Cold-induced asthma/bronchospasm
* Previous hand/finger injuries that impair dexterity and hand function.
* Metal hardware (plates/screws) in the forearms and hands.
* Current use of medications or dietary supplements that could alter cardiovascular, thermoregulatory, or vascular control (e.g., anti-hypertensives, statins).
* Known allergies to medical adhesives.
* Heart, lung, kidney, muscle, or nerve disorder(s)
* A planned MRI during the study or within 2 days after completing a cold test.
* Women who are pregnant, planning to become pregnant, or breastfeeding.
* Not willing to have small areas of skin on the body shaved (if deemed necessary for attachment of study instrumentation)
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Army Research Institute of Environmental Medicine

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Billie K Alba, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

United States Army Research Institute of Environmental Medicine

Locations

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U.S. Army Research Institute of Environmental Medicine

Natick, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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21-04H

Identifier Type: -

Identifier Source: org_study_id

MO210025

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id