- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05409937
Influence of Wet Clothing on Thermal Protection
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Afton D Seeley, Ph.D.
- Telefonnummer: 508-206-2423
- E-mail: afton.d.seeley.civ@health.mil
Studiesteder
-
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Massachusetts
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Natick, Massachusetts, Forenede Stater, 01760
- Rekruttering
- USARIEM
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Kontakt:
- Afton D Seeley, Ph.D.
- Telefonnummer: 508-206-2423
- E-mail: afton.d.seeley.civ@health.mil
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
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Water-saturated Improved Hot Weather Combat Uniform
|
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Eksperimentel: 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.
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Water-saturated Army Combat Uniform
|
|
Eksperimentel: 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.
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Water-saturated Army Combat Uniform + Silk Weights
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Eksperimentel: 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
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Water-saturated Army Combat Uniform
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Core Temperature
Tidsramme: 5 hours
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Core temperature will be measured using a temperature pill that is inserted as a rectal suppository.
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5 hours
|
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Skin Temperature
Tidsramme: 5 hours
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Skin temperature will be measured using 11 different skin-attached temperature sensors.
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5 hours
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Heart Rate
Tidsramme: 5 hours
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Heart Rate will be measured using telemetry [beats per min]
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5 hours
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Oxygen Consumption/Metabolic Heat Production (MHP)
Tidsramme: flere 5 minutters samlinger op til 1 time
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Iltforbrug og MHP vil blive vurderet ved hjælp af computerstyret indirekte kalorimetri [ml/kg/min; Watt pr. meter i kvadrat]
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flere 5 minutters samlinger op til 1 time
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Thermal Sensation (whole body, feet, and hands)
Tidsramme: multiple 1 minute collections up to 1 hour
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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.
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multiple 1 minute collections up to 1 hour
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Thermal Comfort
Tidsramme: multiple 1 minute collections up to 1 hour
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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).
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multiple 1 minute collections up to 1 hour
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Perceived Skin Wetness
Tidsramme: multiple 1 minute collections up to 1 hour
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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).
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multiple 1 minute collections up to 1 hour
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 21-12H
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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