Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231, United States
NCT Number: NCT06709781
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Dallas, Texas, 75231, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-Burned Individuals
Exclusion criteria
Non-Burned Individuals
Inclusion criteria
Burn Survivors
Exclusion criteria
Burn Survivors
Subjects will exercise for 60 minutes in the heat while being exposed to no cooling modality.
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.
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.
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.
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.
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.
Time frame: At 60 minutes into the intervention.
The subject's heart rate will be measured from ECG electrodes attached to the participant.
Time frame: At 60 minutes into the intervention.
The subject's heart rate will be measured from ECG electrodes attached to the participant.
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)
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)
University of Texas Southwestern Medical Center
Other
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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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