Clinical trial NCT06709781: Cardiovascular Responses in Burn Survivors During Exercise
Official title: Cardiovascular Responses in Burn Survivors During Exercise
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burn Injury
Keywords: skin graft
thermoregulation
burn survivor
3rd degree burn injury
human
cooling
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: OTHER

Brief summary: 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.

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, 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.

Eligibility criteria: 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% 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: 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

Primary outcomes:
measure: Change in Core Temperature (°C) During Control Intervention
timeFrame: At 0 minutes and 60 minutes into the intervention.
measure: Change in Core Temperature (°C) During Water-Spray Intervention
timeFrame: At 0 minutes and 60 minutes into the intervention.
Secondary outcomes:
measure: Skin Temperature (°C) Following Control Intervention
timeFrame: At 60 minutes into the intervention.
measure: Skin Temperature (°C) Following Water-Spray Intervention
timeFrame: At 60 minutes into the intervention.
measure: Heart Rate Following Control Intervention
timeFrame: At 60 minutes into the intervention.
measure: Heart Rate Following Water-Spray Intervention
timeFrame: At 60 minutes into the intervention.
measure: Mean Arterial Blood Pressure Following Control Intervention
timeFrame: At 60 minutes into the intervention.
measure: Mean Arterial Blood Pressure Following Water-Spray Intervention
timeFrame: At 60 minutes into the intervention.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Craig G Crandall, PhD
role: PRINCIPAL_INVESTIGATOR
References: