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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04512976
Other study ID # STU_2020_0334
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2021
Est. completion date March 1, 2023

Study information

Verified date March 2023
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date March 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Cooing Modalities
Subjects will exercise for 60 minutes in the indicated environmental condition 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. A 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 well-healed grafted skin throughout the exercise bout. A combination of a fan and skin wetting will be performed by simultaneously applying both cooling modalities throughout the exercise bout.

Locations

Country Name City State
United States Institute for Exercise and Environmental Medincine - Texas Health Presbyterian Hospital Dallas Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill. During exercise, one's core body temperature will increase. This device will measure this increase in core body temperature throughout the exercise. Prior to and throughout each bout of exercise; an average of 120 minutes.
Secondary Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. During exercise, one's skin temperature will increase. This device will measure this increase in skin temperature throughout the exercise. Prior to and throughout each bout of exercise; an average of 120 minutes.
Secondary Heart rate will be measured from ECG electrodes attached to the participant. During exercise, one's heart rate will increase. This device will measure this increase in heart rate throughout the exercise. Prior to and throughout each bout of exercise; an average of 120 minutes.
Secondary Arterial blood pressure will be measured using a standard arm blood pressure cuff. During exercise, one's blood pressure will increase. This device will measure this increase in blood pressure throughout the exercise. Prior to and throughout each bout of exercise; an average of 120 minutes.
Secondary Cardiac output (how much blood is ejected from the heart) will be measured using a nitrous oxide rebreathing approach. During exercise, one's cardiac output will increase. This device will measure this increase in cardiac output throughout the exercise. Prior to and throughout each bout of exercise; an average of 120 minutes.
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