Cardiovascular Responses in Burn Survivors During Exercise

NCT06709781 | Recruiting

• 1 other identifier: STU_2020-0334_c
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Injury

Keywords

skin graft; thermoregulation; burn survivor; 3rd degree burn injury; human; cooling

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Skin Temperature (°C) Following Control Intervention

  At 60 minutes into the intervention.

• Skin Temperature (°C) Following Water-Spray Intervention

  At 60 minutes into the intervention.

• Heart Rate Following Control Intervention

  At 60 minutes into the intervention.

• Heart Rate Following Water-Spray Intervention

  At 60 minutes into the intervention.

• Mean Arterial Blood Pressure Following Control Intervention

  At 60 minutes into the intervention.

Study Arms (2)

Non-Burned Individuals

EXPERIMENTAL

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); Other: Water Spray

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

EXPERIMENTAL

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); Other: Water Spray

Interventions

Control (no cooling modalities) OTHER

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

Burn Survivors (20% or more Burn Surface Area burn-injured); Non-Burned Individuals

Water Spray 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); Non-Burned Individuals

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female subjects
• years of age.
• Free of any underlying medical conditions

You may not qualify if:

• 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
• Healthy male and female subjects
• 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
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas

Dallas, Texas, 75231, United States

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Craig G Crandall, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin M Harper, B.S.

CONTACT

214-345-4737; erinharper@texashealth.org

Craig G Crandall, PhD

CONTACT

214-345-4623; craigcrandall@texashealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking is required as each subject will be exposed to the cooling modality and the control (non-cooling) trial.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Model Details: 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).

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: January 8, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)