NCT04512976

Exercise in Burn Survivors: Cooling Modalities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Burn Injury

Interventions

Type	Name	Description
OTHER	Control (no cooling modalities)	Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality.
OTHER	Water Spray Only	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.
OTHER	Fan Only	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.
OTHER	Water Spray and Fan	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.

Timeline

• Start date: 2021-01-15
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2020-08-14
• Last updated: 2025-07-28
• Results posted: 2024-10-21

Locations

1 site across 1 country: United States