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The Effect of Simulated Burn Injury on Post Exercise Recovery in Hot Environments (HSR)

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Enrolling

Conditions

Body Temperature Regulation
Cardiovascular Physiology
Burn Injury

Treatments

Other: Simulated burn injury via application of absorbent and impermeable material over 60% of the body

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07050264
STU20251344
R35GM152112-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Burn survivors have difficulty thermoregulating due to reduced skin blood flow and sweating responses at the grafted sites. It has been previously shown that this impaired heat dissipation results in burn survivors experiencing higher core temperatures for a given exercise/environmental exposure compared to non-burned individuals. This also holds true with the use of simulated burn injury. When an absorbent material is applied to the skin over a desired amount of body surface area, it replicates a burn injury of the same size (i.e., simulated burn injury). A question that remains unknown is if this impaired thermoregulation in burn survivors would affect post-exercise core temperature recovery, i.e., do burn survivors recover slower than non-burned individuals upon stopping exercise. To that end, the primary objective of this project is to determine the rate at which body temperature and other markers of thermoregulation recover after a bout of exercise in the heat and if this response is different in the same individual with and without simulated burn injury.

Enrollment

28 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18 and 65 years of age
  • free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram.

Exclusion criteria

  • Known heart disease
  • other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, etc. as well as serious abnormalities detected on routine screening.
  • Individuals who are pregnant, planning to become pregnant, or breastfeeding will be excluded, this will be confirmed in females using a urine pregnancy test.
  • Taking prescribed medications (such as beta blockers and non-dihydropyridine calcium channel blockers) or over-the-counter medications that have known influences on thermoregulatory response.
  • Current smokers, as well as individuals who regularly smoked within the past 3 years.
  • body mass index is ≥ 31 kg/m2.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

28 participants in 4 patient groups

Hot and Humid with simulated burns
Experimental group
Description:
Individuals will be exposed to hot and humid conditions with a simulated burn injury.
Treatment:
Other: Simulated burn injury via application of absorbent and impermeable material over 60% of the body
Hot and Humid without simulated burns
No Intervention group
Description:
Individuals will be exposed to hot and humid conditions without a simulated burn injury.
Hot and Dry with simulated burns
Experimental group
Description:
Individuals will be exposed to hot and dry conditions with a simulated burn injury.
Treatment:
Other: Simulated burn injury via application of absorbent and impermeable material over 60% of the body
Hot and Dry without simulated burns
No Intervention group
Description:
Individuals will be exposed to hot and dry conditions without a simulated burn injury.

Trial contacts and locations

1

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Central trial contact

Elizabeth A Gideon, PhD; Erin M Harper, B.S.

Data sourced from clinicaltrials.gov

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