Cardiovascular Responses in Burn Survivors During Exercise

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-08

Study Completion Date

2027-01-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Burn Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

The investigators will conduct a randomized crossover design study.

Burn survivors (20% or more burn surface area) and non-burned individuals will perform 60-min of exercise in the heat on two occasions - one being a control (no cooling trial) and one with the implementation of the cooling modality (water spray).

Primary Study Purpose

OTHER

Blinding Strategy

NONE

No masking is required as each subject will be exposed to the cooling modality and the control (non-cooling) trial.

Study Groups

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Non-Burned Individuals

Non-burned individuals will exercise for 60 minutes in the heat while being exposed to either no cooling or cooling via skin wetting (two trials).

Group Type EXPERIMENTAL

Control (no cooling modalities)

Intervention Type OTHER

Subjects will exercise for 60 minutes in the heat while being exposed to no cooling modality.

Water Spray

Intervention Type OTHER

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.

Burn Survivors (20% or more Burn Surface Area burn-injured)

Burn survivors with 20% or more BSA (burn surface area) burn-injured will exercise for 60 in the heat while being exposed to either no cooling or cooling via skin wetting (two trials).

Group Type EXPERIMENTAL

Control (no cooling modalities)

Intervention Type OTHER

Subjects will exercise for 60 minutes in the heat while being exposed to no cooling modality.

Water Spray

Intervention Type OTHER

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.

Interventions

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Control (no cooling modalities)

Subjects will exercise for 60 minutes in the heat while being exposed to no cooling modality.

Intervention Type OTHER

Water Spray

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects
* 18-65 years of age.
* Free of any underlying medical conditions

* Healthy male and female subjects
* 18-65 years of age.
* Free of any underlying medical conditions
* Having a burn injury covering 20% or more 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

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes