Skin Wetting in Burn Survivors

Обзор

This project will identify the efficacy of whole body skin wetting aimed to attenuate excessive elevations in internal body temperatures during physical activity in well-healed burn survivors. The investigators will conduct a randomized crossover design study. Non-burned control subjects, subjects who experienced burns covering \~20% to 40% of their body surface area, and subject having burns \>40% of their body surface area will be investigated. Subjects will exercise in heated environmental conditions while receiving no cooling or whole body skin wetting.

Вмешательства

• Другое Whole body cooling
  Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to whole body skin wetting. Skin wetting will be performed by spraying water onto the whole body throughout the exercise bout.
• Другое Non-cooling
  Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modalities.

Первичные конечные точки

• Core Temperature [Срок оценки: Prior to and throughout the bout of exercise; an average of 90 minutes.]

Вторичные конечные точки (3)

• Mean Skin Temperature [Срок оценки: Prior to and throughout the bout of exercise; an average of 90 minutes.]
• Rate Pressure Product [Срок оценки: Prior to and throughout the bout of exercise; an average of 90 minutes.]
• Whole body sweat rate [Срок оценки: Before and after exercise. 2 min per measure.]

Критерии участия

Inclusion Criteria: Non-burn survivors

• Healthy male and female subjects
• 18-65 years of age.
• Free of any underlying medical conditions

Exclusion Criteria (non-burned individuals):

• Any burn-related injuries resulting in at least one night of hospitalization.
• Heart disease or any other chronic medical condition requiring regular medical therapy including cancer, diabetes, and hypertension.
• Abnormalities detected on routine screening
• Individuals who participate in a structured aerobic exercise training program at moderate to high intensities.
• Current smokers, as well as individuals who regularly smoked within the past 3 years.
• Body mass index of greater than 30 kg/m\^2.
• Pregnant individuals

Inclusion Criteria (burn survivors):

• Healthy male and female subjects
• 18-65 years of age.
• Free of any underlying medical conditions
• Having a burn injury covering 20-40% or >40% of the participant's body surface area; at least 50% of those burn injuries must be full thickness that required skin grafting.
• Participants must have been hospitalized due to the burn injury for a minimum of 15 days

Exclusion Criteria (burn survivors):

• Any burn-related injuries resulting in at least one night of hospitalization.
• Heart disease or any other chronic medical condition requiring regular medical therapy including cancer, diabetes, and hypertension.
• Abnormalities detected on routine screening
• Individuals who participate in a structured aerobic exercise training program at moderate to high intensities.
• Current smokers, as well as individuals who regularly smoked within the past 3 years.
• Body mass index of greater than 30 kg/m\^2.
• Pregnant individuals
• Extensive unhealed injured skin

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Institute for Exercise and Environmental Medicine — Dallas

Идентификаторы

NCT: NCT06529757 · STU_2020_0334_B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗