- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07050264
- Original Trial
The Effect of Simulated Burn Injury on Post Exercise Recovery in Hot Environments (HSR)
May 21, 2026 updated by: Craig Crandall, University of Texas Southwestern Medical Center
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.
Study Overview
Status
Recruiting
Study Type
Interventional
Enrollment (Estimated)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Erin M Harper, B.S.
- Phone Number: 12143454737
- Email: erin.harper2@utsouthwestern.edu
Study Contact Backup
- Name: Elizabeth A Gideon, PhD
- Email: betsygideon@texashealth.org
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75231
- Recruiting
- Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas
-
Contact:
- Craig G Crandall, PhD
- Email: craigcrandall@texashealth.org
-
Sub-Investigator:
- Elizabeth A Gideon, PhD
-
Contact:
- Erin M Harper, B.S.
- Phone Number: 214-345-4737
- Email: erin.harper2@utsouthwestern.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hot and Humid with simulated burns
Individuals will be exposed to hot and humid conditions with a simulated burn injury.
|
Simulated burn injury via application of absorbent and impermeable material over 60% of the body
|
|
No Intervention: Hot and Humid without simulated burns
Individuals will be exposed to hot and humid conditions without a simulated burn injury.
|
|
|
Experimental: Hot and Dry with simulated burns
Individuals will be exposed to hot and dry conditions with a simulated burn injury.
|
Simulated burn injury via application of absorbent and impermeable material over 60% of the body
|
|
No Intervention: Hot and Dry without simulated burns
Individuals will be exposed to hot and dry conditions without a simulated burn injury.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Core Temperature
Time Frame: From baseline to end of 60 minutes of recovery
|
From baseline to end of 60 minutes of recovery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Heart Rate
Time Frame: From baseline to the end of 60 minutes of recovery
|
From baseline to the end of 60 minutes of recovery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Craig G Crandall, PhD, University of Texas Southwestern Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Study Registration Dates
First Submitted
June 25, 2025
First Submitted That Met QC Criteria
June 25, 2025
First Posted (Actual)
July 3, 2025
Study Record Updates
Last Update Posted (Actual)
May 26, 2026
Last Update Submitted That Met QC Criteria
May 21, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU20251344
- R35GM152112-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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