Exercise in Burn Survivors: Cooling Modalities

July 16, 2025 updated by: Craig Crandall, University of Texas Southwestern Medical Center
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 investigators will conduct a randomized crossover design study. Non-burned control subjects, subjects who experienced burns covering ~20% to 40% of their body surface area, and subject having burns >40% of their body surface area will be investigated. Subjects will exercise in heated environmental conditions while receiving the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of fan and skin wetting.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 experiencing such an injury per year. These burn injuries can severely compromise body temperature regulation, owing to permanent impairments in the primary thermoeffectors necessary to dissipate heat, namely profoundly blunted skin blood flow and sweating responses in the injured skin. The investigators propose that this heat intolerance deters burn survivors from participating in physical activity, including activities of daily living, necessary to avoid the adverse cardiovascular and metabolic sequela of a sedentary lifestyle. Consistent with hypothesis, years after the injury burn survivors have a very low aerobic capacity; greater all-cause mortality rates; greater hospitalization days for circulatory diseases; and suffer from greater incidences of ischemic heart disease, heart failure, diabetes, and cerebrovascular disease (including stroke) relative to matched non-burned cohorts. The primary goal of this project is to identify modalities to attenuate excessive elevations in skin and core body temperatures during physical activity in well-healed burn survivors. The implementation of such modalities will eliminate heat intolerance as a barrier to participation in activities that are necessary to improve/maintain cardiovascular health in this vulnerable population. This project will investigate whether increased skin wetness, with and without accompanying fan use, will restore otherwise impaired evaporative cooling of well-healed burn survivors, with the extent of that improvement predicated on the environmental conditions and the percentage of body surface area burned.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75231
        • Institute for Exercise and Environmental Medincine - Texas Health Presbyterian Hospital Dallas

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C)
Burn survivors with 20-40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (30°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.
Other: Control (no cooling modalities)
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.
Other: Water Spray Only

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the skin wetting modality.

Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.

Other: Fan Only

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the fan cooling modality.

The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.

Other: Water Spray and Fan

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to both the skin wetting and fan cooling modalities.

The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.

Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Experimental: Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (39°C)
Burn survivors with 20-40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (39°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.
Other: Control (no cooling modalities)
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.
Other: Water Spray Only

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the skin wetting modality.

Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.

Other: Fan Only

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the fan cooling modality.

The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.

Other: Water Spray and Fan

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to both the skin wetting and fan cooling modalities.

The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.

Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Experimental: Non-Burned Individuals in Ambient Heat (30°C)
Non-burned individuals will exercise for 60 minutes in ambient heat (30°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.
Other: Control (no cooling modalities)
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.
Other: Water Spray Only

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the skin wetting modality.

Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.

Other: Fan Only

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the fan cooling modality.

The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.

Other: Water Spray and Fan

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to both the skin wetting and fan cooling modalities.

The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.

Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Experimental: Non-Burned Individuals in Ambient Heat (39°C)
Non-burned individuals will exercise for 60 minutes in ambient heat (39°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.
Other: Control (no cooling modalities)
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.
Other: Water Spray Only

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the skin wetting modality.

Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.

Other: Fan Only

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the fan cooling modality.

The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.

Other: Water Spray and Fan

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to both the skin wetting and fan cooling modalities.

The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.

Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Experimental: Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C)
Burn survivors with >40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (30°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.
Other: Control (no cooling modalities)
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.
Other: Water Spray Only

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the skin wetting modality.

Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.

Other: Fan Only

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the fan cooling modality.

The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.

Other: Water Spray and Fan

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to both the skin wetting and fan cooling modalities.

The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.

Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
Experimental: Burn Survivors (>40% Burn Surface Area) in Ambient Heat (39°C)
Burn survivors with >40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (39°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.
Other: Control (no cooling modalities)
Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.
Other: Water Spray Only

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the skin wetting modality.

Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.

Other: Fan Only

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to the fan cooling modality.

The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.

Other: Water Spray and Fan

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to both the skin wetting and fan cooling modalities.

The fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.

Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Core Temperature (°C) During Control Intervention
Time Frame: At 0 minutes and 60 minutes into the intervention.
The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.
At 0 minutes and 60 minutes into the intervention.
Change in Core Temperature (°C) During Fan Intervention
Time Frame: At 0 minutes and 60 minutes into the intervention.
The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.
At 0 minutes and 60 minutes into the intervention.
Change in Core Temperature (°C) During Water-Spray Intervention
Time Frame: At 0 minutes and 60 minutes into the intervention.
The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.
At 0 minutes and 60 minutes into the intervention.
Change in Core Temperature (°C) During Water-Spray and Fan Intervention
Time Frame: At 0 minutes and 60 minutes into the intervention.
The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.
At 0 minutes and 60 minutes into the intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Skin Temperature (°C) Following Control Intervention
Time Frame: At 60 minutes into the intervention.
The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.
At 60 minutes into the intervention.
Skin Temperature (°C) Following Fan Intervention
Time Frame: At 60 minutes into the intervention.
The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.
At 60 minutes into the intervention.
Skin Temperature (°C) Following Water-Spray Intervention
Time Frame: At 60 minutes into the intervention.
The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.
At 60 minutes into the intervention.
Skin Temperature (°C) Following Water-Spray and Fan Intervention
Time Frame: At 60 minutes into the intervention.
The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.
At 60 minutes into the intervention.
Heart Rate Following Control Intervention
Time Frame: At 60 minutes into the intervention.
The subject's heart rate will be measured from ECG electrodes attached to the participant.
At 60 minutes into the intervention.
Heart Rate Following Fan Intervention
Time Frame: At 60 minutes into the intervention.
The subject's heart rate will be measured from ECG electrodes attached to the participant.
At 60 minutes into the intervention.
Heart Rate Following Water-Spray Intervention
Time Frame: At 60 minutes into the intervention.
The subject's heart rate will be measured from ECG electrodes attached to the participant.
At 60 minutes into the intervention.
Heart Rate Following Water-Spray and Fan Intervention
Time Frame: At 60 minutes into the intervention.
The subject's heart rate will be measured from ECG electrodes attached to the participant.
At 60 minutes into the intervention.
Mean Arterial Blood Pressure Following Control Intervention
Time Frame: At 60 minutes into the intervention.

The subject's mean arterial blood pressure will be measured using a standard arm blood pressure cuff.

Mean Arterial Pressure (MAP) is a common physiological measure calculated by adding the diastolic blood pressure value to one third of the difference between the systolic (SBP) and diastolic (DBP) blood pressure values.

MAP = DBP + 1/3(SBP - DBP)
At 60 minutes into the intervention.
Mean Arterial Blood Pressure Following Fan Intervention
Time Frame: At 60 minutes into the intervention.

The subject's mean arterial blood pressure will be measured using a standard arm blood pressure cuff.

Mean Arterial Pressure (MAP) is a common physiological measure calculated by adding the diastolic blood pressure value to one third of the difference between the systolic (SBP) and diastolic (DBP) blood pressure values.

MAP = DBP + 1/3(SBP - DBP)
At 60 minutes into the intervention.
Mean Arterial Blood Pressure Following Water-Spray Intervention
Time Frame: At 60 minutes into the intervention.

The subject's mean arterial blood pressure will be measured using a standard arm blood pressure cuff.

Mean Arterial Pressure (MAP) is a common physiological measure calculated by adding the diastolic blood pressure value to one third of the difference between the systolic (SBP) and diastolic (DBP) blood pressure values.

MAP = DBP + 1/3(SBP - DBP)
At 60 minutes into the intervention.
Mean Arterial Blood Pressure Following Water-Spray and Fan Intervention
Time Frame: At 60 minutes into the intervention.

The subject's mean arterial blood pressure will be measured using a standard arm blood pressure cuff.

Mean Arterial Pressure (MAP) is a common physiological measure calculated by adding the diastolic blood pressure value to one third of the difference between the systolic (SBP) and diastolic (DBP) blood pressure values.

MAP = DBP + 1/3(SBP - DBP)
At 60 minutes into the intervention.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of General Medical Sciences (NIGMS)

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU_2020_0334
  • 2R01GM068865-13A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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