Burn Injury Clinical Trial
Official title:
Exercise in Burn Survivors: Cooling Modalities
Verified date | March 2023 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Institute for Exercise and Environmental Medincine - Texas Health Presbyterian Hospital Dallas | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
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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