Cardiovascular Responses in Burn Survivors During Exercise

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.

Study Overview

• Status: Recruiting
• Conditions: Burn Injury
• Intervention / Treatment: Other: Control (no cooling modalities); Other: Water Spray

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin M Harper, B.S.; Phone Number: 214-345-4737; Email: erinharper@texashealth.org
• Study Contact Backup: Name: Craig G Crandall, PhD; Phone Number: 214-345-4623; Email: craigcrandall@texashealth.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas
      • Contact: Erin M Harper, B.S.; Phone Number: 214-345-4737; Email: erinharper@texashealth.org
      • Contact: Craig G Crandall, PhD; Phone Number: 214-345-4623; Email: craigcrandall@texashealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: Control (no cooling modalities); Subjects will exercise for 60 minutes in the heat while being exposed to no cooling modality.; 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.
Experimental: 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).	Other: Control (no cooling modalities); Subjects will exercise for 60 minutes in the heat while being exposed to no cooling modality.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Core Temperature (°C) During Control Intervention	The subject's core body temperature will be measured from gastrointestinal or rectal temperature measures.	At 0 minutes and 60 minutes into the intervention.
Change in Core Temperature (°C) During Water-Spray Intervention	The subject's core body temperature will be measured from gastrointestinal or rectal temperature measures.	At 0 minutes and 60 minutes into the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Temperature (°C) Following Control Intervention	The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.	At 60 minutes into the intervention.
Skin Temperature (°C) Following Water-Spray Intervention	The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.	At 60 minutes into the intervention.
Heart Rate Following Control Intervention	The subject's heart rate will be measured from ECG electrodes attached to the participant.	At 60 minutes into the intervention.
Heart Rate Following Water-Spray Intervention	The subject's heart rate will be measured from ECG electrodes attached to the participant.	At 60 minutes into the intervention.
Mean Arterial Blood Pressure Following Control Intervention	The subject's mean arterial blood pressure will be measured using a standard arm blood pressure cuff. Mean Arterial Pressure (MAP) is a common physiological measure calculated by adding the diastolic blood pressure value to one third of the difference between the systolic (SBP) and diastolic (DBP) blood pressure values. MAP = DBP + 1/3(SBP - DBP)	At 60 minutes into the intervention.
Mean Arterial Blood Pressure Following Water-Spray Intervention	The subject's mean arterial blood pressure will be measured using a standard arm blood pressure cuff. Mean Arterial Pressure (MAP) is a common physiological measure calculated by adding the diastolic blood pressure value to one third of the difference between the systolic (SBP) and diastolic (DBP) blood pressure values. MAP = DBP + 1/3(SBP - DBP)	At 60 minutes into the intervention.

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Craig G Crandall, PhD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: thermoregulation; human; cooling; skin graft; burn survivor; 3rd degree burn injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: STU_2020-0334_c

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No