IEEM- Work:Rest Cycles in Burn Survivors- Humidity

August 19, 2025 updated by: Craig Crandall, University of Texas Southwestern Medical Center
The purpose of this project is to identify the effects of a severe burn injuries in humans on core temperature responses during work:rest cycles while in a heated environment.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Non-burned control participants and participants who experienced serious burns covering ≥20% of their body surface area will be investigated. Participants will undergo up to three work:rest cycles in the heat (via our environmental chamber) set to no higher than 40 °C. The work:rest cycle will comprise of 30 min of exercise that is followed by up to 20 min of rest, while staying in the heated conditions. Three consecutive work:rest cycles will be performed as illustrated in the protocol document. During one visit, this protocol will be performed in a low humidity state. During the other visit (randomized and crossover), this protocol will be performed in a high humidity state.

Study Type

Observational

Enrollment (Estimated)

70

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

Study Contact Backup

Study Locations

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

Sampling Method

Non-Probability Sample

Study Population

  1. Non-burn control.
  2. Individuals 20 - 40% of their body surface area burned.
  3. Individuals with greater than 40% of their body surface area burned.

Description

Inclusion Criteria for Non-burned Individuals:

  • Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants must be between the ages of 18 and 65.

Exclusion Criteria for Non-burned Individuals:

  • Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 3 years will be excluded. Participants may also be excluded if body mass index is ≥ 31 kg/m2 will likewise be excluded. Participants must not have had a serious burn injury requiring more than 1 night stay in the hospital.

Inclusion Criteria for Individuals with up to 40% of their body surface area burned (moderate burn group):

- Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants who have sustained a burn injury must have a burn covering 20-40% of their body surface area and 50% of those burns must be full-thickness burns requiring skin grafts. Participants must be between the ages of 18 and 65.

Exclusion Criteria for Individuals with up to 40% of their body surface area burned (moderate burn group):

- Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 3 years will be excluded. Participants may also be excluded if body mass index is ≥ 31 kg/m2 will likewise be excluded.

Inclusion Criteria for Individuals with greater than 40% of their body surface area burned (large burn group):

- Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants who have sustained a burn injury must have a burn covering more than 40% of their body surface area and 50% of those burns must be full-thickness burns requiring skin grafts. Participants must be between the ages of 18 and 65.

Exclusion Criteria for Individuals with greater than 40% of their body surface area burned (large burn group):

- Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 3 years will be excluded. Participants may also be excluded if body mass index is ≥ 31 kg/m2 will likewise be excluded.

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

Cohorts and Interventions

Group / Cohort
Non-Burned Individuals in Low Humidity Environment
Non-burned individuals will perform up to three work:rest cycles in a heated environment with low humidity, with each work:rest cycle lasting up to 50 minutes.
Moderate Burned Individuals in Low Humidity Environment
Individuals with moderate sized burn injuries will perform up to three work:rest cycles in a heated environment with low humidity, with each work:rest cycle lasting up to 50 minutes.
Large Burned Individuals in Low Humidity Environment
Individuals with large sized burn injuries will perform up to three work:rest cycles in a heated environment with low humidity, with each work:rest cycle lasting up to 50 minutes.
Non-Burned Individuals in High Humidity Environment
Non-burned individuals will perform up to three work:rest cycles in a heated environment with high humidity, with each work:rest cycle lasting up to 50 minutes.
Moderate Burned Individuals in High Humidity Environment
Individuals with moderate sized burn injuries will perform up to three work:rest cycles in a heated environment with high humidity, with each work:rest cycle lasting up to 50 minutes.
Large Burned Individuals in HIgh Humidity Environment
Individuals with large sized burn injuries will perform up to three work:rest cycles in a heated environment with high humidity, with each work:rest cycle lasting up to 50 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in core temperature
Time Frame: From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes.
Change in core body temperature will be measured either from a temperature sensor pill or from a rectal thermometer.
From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heart Rate
Time Frame: From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes.
Heart rate will be measured from ECG electrodes attached to the participant.
From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Texas Health Resources

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)

August 15, 2025

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2031

Study Registration Dates

First Submitted

May 2, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU20250255

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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