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Influence of Wet Clothing on Thermal Protection

Primary Purpose

Low Body Temperatures

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water-saturated Improved Hot Weather Combat Uniform
Water-saturated Army Combat Uniform
Water-saturated Army Combat Uniform + Silk Weights
Sponsored by
United States Army Research Institute of Environmental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Body Temperatures

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • USARIEMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Improved Hot Weather Combat Uniform

Army Combat Uniform

Army Combat Uniform + Silk Weights

Army Combat Uniform- XR

Arm Description

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.

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.

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.

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

Outcomes

Primary Outcome Measures

Core Temperature
Core temperature will be measured using a temperature pill that is inserted as a rectal suppository.
Skin Temperature
Skin temperature will be measured using 11 different skin-attached temperature sensors.

Secondary Outcome Measures

Heart Rate
Heart Rate will be measured using telemetry [beats per min]
Oxygen Consumption/Metabolic Heat Production (MHP)
Oxygen consumption and MHP will be assessed using computerized indirect calorimetry [ml/kg/min; Watts per meter squared]
Thermal Sensation (whole body, feet, and hands)
Thermal sensation will be assessed using the American Society of Heating, Refrigerating and Air-conditioning Engineers Thermal Sensation Scale. This scale has numbers from -4 to +4 with every whole number accompanied by a verbal expression. The verbal expressions are used only to give the subject a relative feeling pertaining to the relative sensation. For example, -4 is associated with very cold whereas +4 is associated with very hot.
Thermal Comfort
Thermal comfort will be assessed using a standard Thermal Comfort Scale. We will ask volunteers to rate how comfortable they feel with respect to temperature sensation. The scale has numbers ranging from 0 to 4 and with descriptors ranging from comfortable (0) to intolerable (4).
Perceived Skin Wetness
Perceived Skin Wetness will be assessed using an adapted Skin Wetness Perception Scale. The scale ranges from 0 (extremely dry) to -6 (extremely wet; soaked).

Full Information

First Posted
May 24, 2022
Last Updated
January 25, 2023
Sponsor
United States Army Research Institute of Environmental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05409937
Brief Title
Influence of Wet Clothing on Thermal Protection
Official Title
Influence of Wet Clothing on Thermal Protection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Army Research Institute of Environmental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Participants, in their first visit, will undergo baseline weighted treadmill walking consisting of ~20 min of treadmill walking with a load of 77lbs followed by ~25 min of treadmill walking with a load of 38.5lbs. They will also have their body composition evaluated (DEXA) and be fit for each uniform ensemble. This first laboratory visit will require ~3 hrs. On separate days, participants will complete 4 experimental trials. After being submerged up to the neck in warm water for two minutes, three of the trials will ask that the participant move to a 41°F air environment, stand with minimal movement for 60 min, complete 60 min of weighted (38.5lb) treadmill walking at 2 mph, and up to 4% grade, and then complete 60 min of weighted (38.5lb) treadmill walking at 2.5 mph and up to 4% grade. Each of these three experimental trial visits will require ~5 hrs. A single trial will ask that after being saturated in warm water, participants enter a 41°F air environment, immediately begin weighted treadmill walking (38.5lbs) at 2.0mph and up to 4% grade for a duration of 60 min before standing with minimal movement for 60 min. This trial will require ~4 hrs. During all experimental trials, the primary outcomes include core temperature, measured continuously using a small pill inserted as a rectal suppository, and skin temperature, measured continuously using 11 small skin attached sensors. Secondary outcomes include metabolic rate, heart rate, thermal perceptions, and changes in body mass. Non-federally employed civilians may be eligible to be paid $13.50/hour for participation (for a total of up to $310).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Body Temperatures

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Improved Hot Weather Combat Uniform
Arm Type
Experimental
Arm Description
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.
Arm Title
Army Combat Uniform
Arm Type
Experimental
Arm Description
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.
Arm Title
Army Combat Uniform + Silk Weights
Arm Type
Experimental
Arm Description
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.
Arm Title
Army Combat Uniform- XR
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Water-saturated Improved Hot Weather Combat Uniform
Intervention Description
Water-saturated Improved Hot Weather Combat Uniform
Intervention Type
Other
Intervention Name(s)
Water-saturated Army Combat Uniform
Intervention Description
Water-saturated Army Combat Uniform
Intervention Type
Other
Intervention Name(s)
Water-saturated Army Combat Uniform + Silk Weights
Intervention Description
Water-saturated Army Combat Uniform + Silk Weights
Primary Outcome Measure Information:
Title
Core Temperature
Description
Core temperature will be measured using a temperature pill that is inserted as a rectal suppository.
Time Frame
5 hours
Title
Skin Temperature
Description
Skin temperature will be measured using 11 different skin-attached temperature sensors.
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Heart Rate
Description
Heart Rate will be measured using telemetry [beats per min]
Time Frame
5 hours
Title
Oxygen Consumption/Metabolic Heat Production (MHP)
Description
Oxygen consumption and MHP will be assessed using computerized indirect calorimetry [ml/kg/min; Watts per meter squared]
Time Frame
multiple 5 minute collections up to 1 hour
Title
Thermal Sensation (whole body, feet, and hands)
Description
Thermal sensation will be assessed using the American Society of Heating, Refrigerating and Air-conditioning Engineers Thermal Sensation Scale. This scale has numbers from -4 to +4 with every whole number accompanied by a verbal expression. The verbal expressions are used only to give the subject a relative feeling pertaining to the relative sensation. For example, -4 is associated with very cold whereas +4 is associated with very hot.
Time Frame
multiple 1 minute collections up to 1 hour
Title
Thermal Comfort
Description
Thermal comfort will be assessed using a standard Thermal Comfort Scale. We will ask volunteers to rate how comfortable they feel with respect to temperature sensation. The scale has numbers ranging from 0 to 4 and with descriptors ranging from comfortable (0) to intolerable (4).
Time Frame
multiple 1 minute collections up to 1 hour
Title
Perceived Skin Wetness
Description
Perceived Skin Wetness will be assessed using an adapted Skin Wetness Perception Scale. The scale ranges from 0 (extremely dry) to -6 (extremely wet; soaked).
Time Frame
multiple 1 minute collections up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Afton D Seeley, Ph.D.
Phone
508-206-2423
Email
afton.d.seeley.civ@health.mil
Facility Information:
Facility Name
USARIEM
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afton D Seeley, Ph.D.
Phone
508-206-2423
Email
afton.d.seeley.civ@health.mil

12. IPD Sharing Statement

Plan to Share IPD
No

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Influence of Wet Clothing on Thermal Protection

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