- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05464758
The Effects of Cold Adaptation on Skin Blood Flow, Hand Function, and Comfort in Healthy Adults
December 18, 2025 updated by: United States Army Research Institute of Environmental Medicine
The Effects of Cold Habituation on Peripheral Blood Flow, Hand Function, and Thermal Comfort
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Natick, Massachusetts, United States, 01760
- U.S. Army Research Institute of Environmental Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cold habituation
8-day cold habituation
|
8 consecutive days of exposure to 8°C air for 120 minutes each day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin blood flow
Time Frame: 8 days
|
Skin blood flow will be measured using non-invasive laser-Doppler flowmetry probes before and during cold exposure.
Output (red blood cell flux) will be divided by mean arterial blood pressure to give an index of cutaneous vascular conductance [CVC, flux/mmHg].
|
8 days
|
|
Skin temperature
Time Frame: 8 days
|
Skin temperatures [in °C] at up to 10 sites on the body will be measured using skin thermistors before and during cold exposure.
Hand and foot skin temperatures will also be measured with a thermography imaging camera.
|
8 days
|
|
Manual dexterity - Pegboard
Time Frame: 3 days
|
Pegboard scores will be obtained before and during cold exposure.
Scores are the number of pegs placed into the boards.
|
3 days
|
|
Manual dexterity - Minnesota Rate of Manipulation
Time Frame: 3 days
|
Minnesota Rate of Manipulation dexterity scores will be obtained before and during cold exposure.
Scores are the time [in seconds] required to move small blocks various distances.
|
3 days
|
|
Hand and finger strength
Time Frame: 3 days
|
Pinch and hand strength [in kg] will be measured using a pinch meter and grip strength device (dynamometer).
Participants will complete three pinch strength tests and one grip strength test before and during cold exposure.
|
3 days
|
|
Cold perception
Time Frame: 5 days
|
Ratings of thermal comfort, thermal sensation, and pain perception [in arbitrary units] will be assessed using visual analogue scales before and during cold exposure.
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metabolic heat production
Time Frame: 5 days
|
Oxygen consumption and carbon dioxide production [ml/kg/min] will be measured using computerized indirect calorimetry before and during cold exposure.
Oxygen consumption and carbon dioxide production will be combined to report metabolic heat production in Watts per meter squared.
|
5 days
|
|
Body core temperature
Time Frame: 5 days
|
Body core temperature [in °C] will be measured using a telemetry pill self-inserted as a suppository during cold exposure.
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5 days
|
|
Blood pressure
Time Frame: 12 days
|
Brachial artery blood pressure [in mmHg] will be measured using an automated blood pressure cuff before and during cold exposure.
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12 days
|
|
Plasma norepinephrine
Time Frame: 3 days
|
Circulating concentrations of norepinephrine [in pg/ml] will be assessed in blood collected via venipuncture before and after cold exposure.
|
3 days
|
|
Heart rate
Time Frame: 12 days
|
Heart rate [in beats per min] will be measured using an automated cuff before and during cold exposure.
|
12 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Billie K Alba, Ph.D., United States Army Research Institute of Environmental Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Actual)
September 13, 2024
Study Completion (Actual)
September 13, 2024
Study Registration Dates
First Submitted
July 6, 2022
First Submitted That Met QC Criteria
July 14, 2022
First Posted (Actual)
July 19, 2022
Study Record Updates
Last Update Posted (Actual)
December 26, 2025
Last Update Submitted That Met QC Criteria
December 18, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 21-04H
- MO210025 (Other Grant/Funding Number: USAMRDC Military Operational Medicine Research Program)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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