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

Cold Exposure Clinical Trial

Official title:

The Effects of Cold Habituation on Peripheral Blood Flow, Hand Function, and Thermal Comfort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05464758
• Other study ID #: 21-04H
• Secondary ID: MO210025
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: United States Army Research Institute of Environmental Medicine
• Contact: Billie K Alba, Ph.D.
• Phone: 508-206-2171
• Email: billie.k.alba.civ[@]health.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cold Exposure

Intervention

Other:
• Repeated cold exposure
8 consecutive days of exposure to 8°C air for 120 minutes each day

Locations

Country	Name	City	State
United States	U.S. Army Research Institute of Environmental Medicine	Natick	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Research Institute of Environmental Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin blood flow	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
Primary	Skin temperature	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
Primary	Manual dexterity - Pegboard	Pegboard scores will be obtained before and during cold exposure. Scores are the number of pegs placed into the boards.	3 days
Primary	Manual dexterity - Minnesota Rate of Manipulation	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
Primary	Hand and finger strength	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
Primary	Cold perception	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	Metabolic heat production	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
Secondary	Body core temperature	Body core temperature [in °C] will be measured using a telemetry pill self-inserted as a suppository during cold exposure.	5 days
Secondary	Blood pressure	Brachial artery blood pressure [in mmHg] will be measured using an automated blood pressure cuff before and during cold exposure.	12 days
Secondary	Plasma norepinephrine	Circulating concentrations of norepinephrine [in pg/ml] will be assessed in blood collected via venipuncture before and after cold exposure.	3 days
Secondary	Heart rate	Heart rate [in beats per min] will be measured using an automated cuff before and during cold exposure.	12 days