Exercise in Burn Survivors: Cooling Modalities

Burn Injury Clinical Trial

Official title:

Exercise in Burn Survivors: Cooling Modalities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512976
• Other study ID #: STU_2020_0334
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Burn Injury
• Burns

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.