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

NCT ID: NCT07050264

Last Updated: 2026-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2028-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Burn Injury Body Temperature Regulation Cardiovascular Physiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Hot and Humid with simulated burns

Individuals will be exposed to hot and humid conditions with a simulated burn injury.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Hot and Humid without simulated burns

Individuals will be exposed to hot and humid conditions without a simulated burn injury.

Group Type NO_INTERVENTION

No interventions assigned to this group

Hot and Dry with simulated burns

Individuals will be exposed to hot and dry conditions with a simulated burn injury.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Hot and Dry without simulated burns

Individuals will be exposed to hot and dry conditions without a simulated burn injury.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Craig Crandall

Professor of Internal Medicine and director of the thermal and vascular physiology lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Craig G Crandall, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erin M Harper, B.S.

Role: CONTACT

12143454737

Elizabeth A Gideon, PhD

Role: CONTACT

Facility Contacts

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Erin M Harper, B.S.

Role: primary

214-345-4737

Craig G Crandall, PhD

Role: backup

Other Identifiers

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R35GM152112-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU20251344

Identifier Type: -

Identifier Source: org_study_id

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