Status:
COMPLETED
Exercise in Burn Survivors: Cooling Modalities
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Burn Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This project will identify the efficacy of cooling modalities aimed to attenuate excessive elevations in skin and internal body temperatures during physical activity in well-healed burn survivors. The...
Detailed Description
Within the United States, 500,000+ individuals are enduring the long-term consequences of severe burn injuries covering 20% or more of their body surface area, with upwards to 11,000 individuals exper...
Eligibility Criteria
Inclusion
- Inclusion Criteria (non-burned individuals):
- 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
Exclusion
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04512976
Start Date
January 15 2021
End Date
March 1 2023
Last Update
July 28 2025
Active Locations (1)
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1
Institute for Exercise and Environmental Medincine - Texas Health Presbyterian Hospital Dallas
Dallas, Texas, United States, 75231