NCT05409937

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

2.1 years

First QC Date

May 24, 2022

Last Update Submit

January 25, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Core Temperature

    Core temperature will be measured using a temperature pill that is inserted as a rectal suppository.

    5 hours

  • Skin Temperature

    Skin temperature will be measured using 11 different skin-attached temperature sensors.

    5 hours

Secondary Outcomes (5)

  • Heart Rate

    5 hours

  • Oxygen Consumption/Metabolic Heat Production (MHP)

    multiple 5 minute collections up to 1 hour

  • Thermal Sensation (whole body, feet, and hands)

    multiple 1 minute collections up to 1 hour

  • Thermal Comfort

    multiple 1 minute collections up to 1 hour

  • Perceived Skin Wetness

    multiple 1 minute collections up to 1 hour

Study Arms (4)

Improved Hot Weather Combat Uniform

EXPERIMENTAL

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.

Other: Water-saturated Improved Hot Weather Combat Uniform

Army Combat Uniform

EXPERIMENTAL

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.

Other: Water-saturated Army Combat Uniform

Army Combat Uniform + Silk Weights

EXPERIMENTAL

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.

Other: Water-saturated Army Combat Uniform + Silk Weights

Army Combat Uniform- XR

EXPERIMENTAL

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

Other: Water-saturated Army Combat Uniform

Interventions

Water-saturated Improved Hot Weather Combat Uniform

Improved Hot Weather Combat Uniform

Water-saturated Army Combat Uniform

Army Combat UniformArmy Combat Uniform- XR

Water-saturated Army Combat Uniform + Silk Weights

Army Combat Uniform + Silk Weights

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760, United States

RECRUITING

Related Publications (1)

  • Seeley AD, Bodurtha PO, Greenfield AM, Pitsas DM, Shaw MA, Caldwell AR, Alba BK, Castellani JW, O'Brien C. Wet military uniforms pose low risk of hypothermia while static in mild cold air. Appl Physiol Nutr Metab. 2024 Dec 1;49(12):1763-1772. doi: 10.1139/apnm-2024-0180. Epub 2024 Sep 13.

Central Study Contacts

Afton D Seeley, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2022

First Posted

June 8, 2022

Study Start

September 2, 2021

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

January 27, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations