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Influence of Wet Clothing on Thermal Protection

25 de enero de 2023 actualizado por: United States Army Research Institute of Environmental Medicine
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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • Massachusetts
      • Natick, Massachusetts, Estados Unidos, 01760

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 49 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Otro: Water-saturated Improved Hot Weather Combat Uniform
Water-saturated Improved Hot Weather Combat Uniform
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.
Otro: Water-saturated Army Combat Uniform
Water-saturated Army Combat Uniform
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.
Otro: Water-saturated Army Combat Uniform + Silk Weights
Water-saturated Army Combat Uniform + Silk Weights
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
Otro: Water-saturated Army Combat Uniform
Water-saturated Army Combat Uniform

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Core Temperature
Periodo de tiempo: 5 hours
Core temperature will be measured using a temperature pill that is inserted as a rectal suppository.
5 hours
Skin Temperature
Periodo de tiempo: 5 hours
Skin temperature will be measured using 11 different skin-attached temperature sensors.
5 hours

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Heart Rate
Periodo de tiempo: 5 hours
Heart Rate will be measured using telemetry [beats per min]
5 hours
Oxygen Consumption/Metabolic Heat Production (MHP)
Periodo de tiempo: múltiples colecciones de 5 minutos hasta 1 hora
El consumo de oxígeno y la MHP se evaluarán mediante calorimetría indirecta computarizada [ml/kg/min; vatios por metro cuadrado]
múltiples colecciones de 5 minutos hasta 1 hora
Thermal Sensation (whole body, feet, and hands)
Periodo de tiempo: multiple 1 minute collections up to 1 hour
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.
multiple 1 minute collections up to 1 hour
Thermal Comfort
Periodo de tiempo: multiple 1 minute collections up to 1 hour
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).
multiple 1 minute collections up to 1 hour
Perceived Skin Wetness
Periodo de tiempo: multiple 1 minute collections up to 1 hour
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).
multiple 1 minute collections up to 1 hour

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

United States Army Research Institute of Environmental Medicine

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

2 de septiembre de 2021

Finalización primaria (Anticipado)

30 de septiembre de 2023

Finalización del estudio (Anticipado)

30 de septiembre de 2023

Fechas de registro del estudio

Enviado por primera vez

24 de mayo de 2022

Primero enviado que cumplió con los criterios de control de calidad

3 de junio de 2022

Publicado por primera vez (Actual)

8 de junio de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de enero de 2023

Última actualización enviada que cumplió con los criterios de control de calidad

25 de enero de 2023

Última verificación

1 de enero de 2023

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 21-12H

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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