Recruiting

Thermal Protection

Sponsor:

United States Army Research Institute of Environmental Medicine

Code:

NCT05409937

Conditions

Low Body Temperatures

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

Water-saturated Improved Hot Weather Combat Uniform

Water-saturated Army Combat Uniform

Water-saturated Army Combat Uniform + Silk Weights

Study Details

Brief summary:

The aim of this investigation is to provide guidance for assessing the influence of wet clothing, and its drying time, on body temperature responses during cold air exposure. Twelve healthy and fit adults (men and women aged 18-49) will complete this study. Four cold air exposures (41°F, 180 min) will be randomly conducted, each while wearing a different clothing ensemble that has been saturated by water. During each cold air exposure, you will be asked to rest for 60 min and perform weighted (38.5lbs) treadmill walking for up to 120 min.

Conditions

Low Body Temperatures

Study ID

NCT05409937

Start date

Sep 2, 2021

Status verified date

Jan, 2023

Completion date

Sep 30, 2023

Anticipated

Primary completion date

Sep 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Military or civilian, male or female, between the ages of 18 (17 if active duty military) and 49 years.
  • Able to carry a rucksack weighing 35 kg (77lbs) for at least 20 minutes and able to carry a rucksack weighing 17.5kg (38.5lbs) for up to 120 minutes
  • In good health as determined by our OMSO (Office of Medical Support and Oversight) General Medical Clearance.
  • Vaccinated against COVID 19.
  • Willing to refrain from heavy exercise and alcoholic beverages for 24 hours before each testing session.
  • Willing to refrain from smoking or tobacco use for 8 hours before each testing session.
  • Willing to refrain from caffeine ingestion for 12 hours before each testing session.
  • Body fat percentage <18% for males, < 24% for females, once 6 individuals of higher body fat (18% or greater for males, 24% or greater for females) have completed the study.

Exclusion Criteria:

  • History of cold injuries.
  • Raynaud's syndrome.
  • Cold-induced asthma/bronchospasm.
  • Medications or dietary supplements that could alter cardiovascular, thermoregulatory, or vascular control.
  • Heart, lung, kidney, muscle, or nerve disorder(s).
  • Planned MRI during or within two days after completing the study.
  • Known allergy to adhesives.
  • Female and pregnant, planning to become pregnant, or breastfeeding.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Improved Hot Weather Combat Uniform

Wearing the Improved Hot Weather Combat Uniform; Asked to perform 60 min of standing with minimal movement, 60 min weighted (38.5lb) treadmill walking at 2.0mph, up to 4% grade, 60 min weight (38.5lb) treadmill walking at 2.5mph, up to 4% grade.

experimental: Army Combat Uniform

Wearing the Army Combat Uniform; Asked to perform 60 min of standing with minimal movement, 60 min weighted (38.5lb) treadmill walking at 2.0mph, up to 4% grade, 60 min weight (38.5lb) treadmill walking at 2.5mph, up to 4% grade.

experimental: Army Combat Uniform + Silk Weights

Wearing the Army Combat Uniform + a base layer of silk weights; Asked to perform 60 min of standing with minimal movement, 60 min weighted (38.5lb) treadmill walking at 2.0mph, up to 4% grade, 60 min weight (38.5lb) treadmill walking at 2.5mph, up to 4% grade.

experimental: Army Combat Uniform- XR

Wearing the Army Combat Uniform; Asked to perform 60 min weighted (38.5lb) treadmill walking at 2.0mph, up to 4% grade, followed by 60 min of standing with minimal movement

Interventions

Water-saturated Improved Hot Weather Combat Uniform

Water-saturated Improved Hot Weather Combat Uniform

Water-saturated Army Combat Uniform

Water-saturated Army Combat Uniform

Water-saturated Army Combat Uniform + Silk Weights

Water-saturated Army Combat Uniform + Silk Weights

Primary outcome measure

  • Core Temperature [ Time Frame: 5 hours ]
  • Skin Temperature [ Time Frame: 5 hours ]

Central Contacts and Locations

Central contacts

Afton D Seeley, Ph.D.

508-206-2423afton.d.seeley.civ@health.mil

Locations

USARIEM

Recruiting

Natick, Massachusetts, United States, 01760

Contacts

Afton D Seeley, Ph.D.

508-206-2423afton.d.seeley.civ@health.mil

More Information

Sponsor

United States Army Research Institute of Environmental Medicine

Last update posted

Jan 27, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Army Research Institute of Environmental Medicine on 2023-01-27.