Study Results
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View full resultsBasic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2021-01-15
2023-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
A subject will only be required to perform exercise across all four cooling modalities for a given environmental temperature (i.e., four exercise bouts); each will not be required to perform exercise across all combinations of environmental temperatures and cooling modalities (i.e., 12 exercise bouts).
PREVENTION
NONE
Study Groups
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Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C)
Burn survivors with 20-40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (30°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.
Control (no cooling modalities)
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.
Water Spray Only
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the skin wetting modality.
Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Fan Only
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the fan cooling modality.
The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
Water Spray and Fan
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to both the skin wetting and fan cooling modalities.
The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (39°C)
Burn survivors with 20-40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (39°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.
Control (no cooling modalities)
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.
Water Spray Only
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the skin wetting modality.
Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Fan Only
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the fan cooling modality.
The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
Water Spray and Fan
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to both the skin wetting and fan cooling modalities.
The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Non-Burned Individuals in Ambient Heat (30°C)
Non-burned individuals will exercise for 60 minutes in ambient heat (30°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.
Control (no cooling modalities)
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.
Water Spray Only
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the skin wetting modality.
Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Fan Only
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the fan cooling modality.
The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
Water Spray and Fan
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to both the skin wetting and fan cooling modalities.
The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Non-Burned Individuals in Ambient Heat (39°C)
Non-burned individuals will exercise for 60 minutes in ambient heat (39°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.
Control (no cooling modalities)
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.
Water Spray Only
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the skin wetting modality.
Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Fan Only
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the fan cooling modality.
The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
Water Spray and Fan
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to both the skin wetting and fan cooling modalities.
The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C)
Burn survivors with \>40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (30°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.
Control (no cooling modalities)
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.
Water Spray Only
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the skin wetting modality.
Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Fan Only
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the fan cooling modality.
The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
Water Spray and Fan
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to both the skin wetting and fan cooling modalities.
The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Burn Survivors (>40% Burn Surface Area) in Ambient Heat (39°C)
Burn survivors with \>40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (39°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.
Control (no cooling modalities)
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.
Water Spray Only
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the skin wetting modality.
Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Fan Only
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the fan cooling modality.
The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
Water Spray and Fan
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to both the skin wetting and fan cooling modalities.
The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Interventions
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Control (no cooling modalities)
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.
Water Spray Only
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the skin wetting modality.
Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Fan Only
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the fan cooling modality.
The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
Water Spray and Fan
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to both the skin wetting and fan cooling modalities.
The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Eligibility Criteria
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Inclusion Criteria
* 18-65 years of age.
* Free of any underlying medical conditions
* 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
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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National Institute of General Medical Sciences (NIGMS)
NIH
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Craig Crandall
Professor
Locations
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Institute for Exercise and Environmental Medincine - Texas Health Presbyterian Hospital Dallas
Dallas, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STU_2020_0334
Identifier Type: -
Identifier Source: org_study_id
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