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Completed

NCT Number: NCT04512976

Exercise in Burn Survivors: Cooling Modalities

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Dallas, Texas, 75231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control (no cooling modalities)

Other

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.

Water Spray Only

Other

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.

Fan Only

Other

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.

Water Spray and Fan

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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)

  10. 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)

  11. 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)

  12. 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)

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2020
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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