Burn InjuryNCT06709781
Cardiovascular Responses in Burn Survivors During Exercise
A study testing Water Spray in people with Burn Injury, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This project will identify the efficacy of cooling modalities aimed to attenuate excessive elevations in skin and internal body temperatures, and associated indices of cardiovascular stress, during physical activity in well-healed burn survivors. The investigators will conduct a randomized crossover design study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn Injury
- What is being tested?
- Water Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2025to 5 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects
- 18-65 years of age.
- Free of any underlying medical conditions
- Healthy male and female subjects
- 18-65 years of age.
- Free of any underlying medical conditions
- Having a burn injury covering 20% or more 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
Who cannot join
- 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.
Show all 15Show fewer
- Pregnant 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
- Extensive unhealed injured skin
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231
About this study
This project will identify the efficacy of cooling modalities aimed to attenuate excessive elevations in skin and internal body temperatures, and associated indices of cardiovascular stress, during physical activity in well-healed burn survivors. The investigators will conduct a randomized crossover design study. Non-burned control subjects and subjects who experienced burns covering 20% or more of their body surface area will be investigated. Subjects will exercise in heated environmental conditions while receiving no cooling (control) as well as skin wetting.
Read the 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, and accompanying cardiovascular stress, 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 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.
- Conditions
- Burn Injury
- Being tested
- Control (no cooling modalities), Water Spray
- Keywords
- skin graft, thermoregulation, burn survivor, 3rd degree burn injury, human, cooling
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control (no cooling modalities)Other
Subjects will exercise for 60 minutes in the heat while being exposed to no cooling modality.
Water SprayOther
Subjects will exercise for 60 minutes in the heat while being exposed to skin wetting. Skin wetting will be performed by spraying water onto the skin throughout the exercise bout.
| Study group | Role | What they receive |
|---|---|---|
| Non-Burned Individuals | Experimental | Non-burned individuals will exercise for 60 minutes in the heat while being exposed to either no cooling or cooling via skin wetting (two trials). Receives: Other: Control (no cooling modalities); Other: Water Spray |
| Burn Survivors (20% or more Burn Surface Area burn-injured) | Experimental | Burn survivors with 20% or more BSA (burn surface area) burn-injured will exercise for 60 in the heat while being exposed to either no cooling or cooling via skin wetting (two trials). Receives: Other: Control (no cooling modalities); Other: Water Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Core Temperature (°C) During Control Intervention
The subject's core body temperature will be measured from gastrointestinal or rectal temperature measures.
Measured: At 0 minutes and 60 minutes into the intervention.
Change in Core Temperature (°C) During Water-Spray Intervention
The subject's core body temperature will be measured from gastrointestinal or rectal temperature measures.
Measured: At 0 minutes and 60 minutes into the intervention.
Secondary outcomes (6)
Skin Temperature (°C) Following Control Intervention
The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.
Measured: At 60 minutes into the intervention.
Skin Temperature (°C) Following Water-Spray Intervention
The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.
Measured: At 60 minutes into the intervention.
Heart Rate Following Control Intervention
The subject's heart rate will be measured from ECG electrodes attached to the participant.
Measured: At 60 minutes into the intervention.
Heart Rate Following Water-Spray Intervention
The subject's heart rate will be measured from ECG electrodes attached to the participant.
Measured: At 60 minutes into the intervention.
Mean Arterial Blood Pressure Following Control 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)
Measured: At 60 minutes into the intervention.
Mean Arterial Blood Pressure Following Water-Spray 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)
Measured: At 60 minutes into the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start8 Jan 2025
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The investigators will conduct a randomized crossover design study. Burn survivors (20% or more burn surface area) and non-burned individuals will perform 60-min of exercise in the heat on two occasions - one being a control (no cooling trial) and one with the implementation of the cooling modality (water spray).
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Crandall, University of Texas Southwestern Medical Center
- Investigators
- Craig G Crandall, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709781
- Sponsor's protocol ID
- STU_2020-0334_c
- Status last verified
- Jun 2026
- First submitted
- 25 Nov 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Responses in Burn Survivors During Exercise
- ClinicalTrials.gov ID
- NCT06709781
- Acronym / sponsor ID
- STU_2020-0334_c
- Conditions
- Burn Injury
- Keywords
- skin graft, thermoregulation, burn survivor, 3rd degree burn injury, human, cooling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will identify the efficacy of cooling modalities aimed to attenuate excessive elevations in skin and internal body temperatures, and associated indices of cardiovascular stress, during physical activity in well-healed burn survivors. The investigators will conduct a randomized crossover design study. Non-burned control subjects and subjects who experienced burns covering 20% or more of their body surface area will be investigated. Subjects will exercise in heated environmental conditions while receiving no cooling (control) as well as skin wetting.
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, and accompanying cardiovascular stress, 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 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will conduct a randomized crossover design study. Burn survivors (20% or more burn surface area) and non-burned individuals will perform 60-min of exercise in the heat on two occasions - one being a control (no cooling trial) and one with the implementation of the cooling modality (water spray).
| Arm | Type | Receives |
|---|---|---|
| Non-Burned Individuals | Experimental | Other: Control (no cooling modalities), Other: Water SprayNon-burned individuals will exercise for 60 minutes in the heat while being exposed to either no cooling or cooling via skin wetting (two trials). |
| Burn Survivors (20% or more Burn Surface Area burn-injured) | Experimental | Other: Control (no cooling modalities), Other: Water SprayBurn survivors with 20% or more BSA (burn surface area) burn-injured will exercise for 60 in the heat while being exposed to either no cooling or cooling via skin wetting (two trials). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy male and female subjects
- 18-65 years of age.
- Free of any underlying medical conditions
- Healthy male and female subjects
- 18-65 years of age.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control (no cooling modalities)Subjects will exercise for 60 minutes in the heat while being exposed to no cooling modality. | Other | Burn Survivors (20% or more Burn Surface Area burn-injured), Non-Burned Individuals |
| Water SpraySubjects will exercise for 60 minutes in the heat while being exposed to skin wetting. Skin wetting will be performed by spraying water onto the skin throughout the exercise bout. | Other | Burn Survivors (20% or more Burn Surface Area burn-injured), Non-Burned Individuals |
Primary outcome
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 or rectal temperature measures.
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 or rectal temperature measures.
6 secondary outcomes
Skin Temperature (°C) Following Control Intervention
Time frame: At 60 minutes into the intervention.
Skin Temperature (°C) Following Water-Spray Intervention
Time frame: At 60 minutes into the intervention.
Heart Rate Following Control Intervention
Time frame: At 60 minutes into the intervention.
Heart Rate Following Water-Spray Intervention
Time frame: At 60 minutes into the intervention.
Mean Arterial Blood Pressure Following Control Intervention
Time frame: At 60 minutes into the intervention.
Mean Arterial Blood Pressure Following Water-Spray Intervention
Time frame: At 60 minutes into the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig G Crandall, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Spray in people with Burn Injury, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Core Temperature (°C) During Control Intervention (time frame: At 0 minutes and 60 minutes into the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.