Exercise in Burn Survivors: Cooling Modalities

NCT04512976 | Completed Results

• 2 other identifiers: STU_2020_03342R01GM068865-13A1
• Study Type: interventional
• Target: 70
• 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 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.

Conditions

Burn Injury

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in Core Temperature (°C) During Control Intervention

  The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.

  At 0 minutes and 60 minutes into the intervention.

• Change in Core Temperature (°C) During Fan Intervention

  The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.

  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 temperature via an ingestible telemetric pill.

  At 0 minutes and 60 minutes into the intervention.

• Change in Core Temperature (°C) During Water-Spray and Fan Intervention

  The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.

  At 0 minutes and 60 minutes into the intervention.

Secondary Outcomes (12)

• Skin Temperature (°C) Following Control Intervention

  At 60 minutes into the intervention.

• Skin Temperature (°C) Following Fan Intervention

  At 60 minutes into the intervention.

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

  At 60 minutes into the intervention.

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

  At 60 minutes into the intervention.

• Heart Rate Following Control Intervention

  At 60 minutes into the intervention.

Study Arms (6)

Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C)

EXPERIMENTAL

Burn survivors with 20-40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (30°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.

Other: Control (no cooling modalities); Other: Water Spray Only; Other: Fan Only; Other: Water Spray and Fan

Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (39°C)

EXPERIMENTAL

Burn survivors with 20-40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (39°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.

Other: Control (no cooling modalities); Other: Water Spray Only; Other: Fan Only; Other: Water Spray and Fan

Non-Burned Individuals in Ambient Heat (30°C)

EXPERIMENTAL

Non-burned individuals will exercise for 60 minutes in ambient heat (30°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.

Other: Control (no cooling modalities); Other: Water Spray Only; Other: Fan Only; Other: Water Spray and Fan

Non-Burned Individuals in Ambient Heat (39°C)

EXPERIMENTAL

Non-burned individuals will exercise for 60 minutes in ambient heat (39°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.

Other: Control (no cooling modalities); Other: Water Spray Only; Other: Fan Only; Other: Water Spray and Fan

Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C)

EXPERIMENTAL

Burn survivors with \>40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (30°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.

Other: Control (no cooling modalities); Other: Water Spray Only; Other: Fan Only; Other: Water Spray and Fan

Burn Survivors (>40% Burn Surface Area) in Ambient Heat (39°C)

EXPERIMENTAL

Burn survivors with \>40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (39°C) while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.

Other: Control (no cooling modalities); Other: Water Spray Only; Other: Fan Only; Other: Water Spray and Fan

Interventions

Control (no cooling modalities) OTHER

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

Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C); Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (39°C); Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C); Burn Survivors (>40% Burn Surface Area) in Ambient Heat (39°C); Non-Burned Individuals in Ambient Heat (30°C); Non-Burned Individuals in Ambient Heat (39°C)

Water Spray Only OTHER

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.

Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C); Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (39°C); Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C); Burn Survivors (>40% Burn Surface Area) in Ambient Heat (39°C); Non-Burned Individuals in Ambient Heat (30°C); Non-Burned Individuals in Ambient Heat (39°C)

Fan Only OTHER

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.

Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C); Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (39°C); Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C); Burn Survivors (>40% Burn Surface Area) in Ambient Heat (39°C); Non-Burned Individuals in Ambient Heat (30°C); Non-Burned Individuals in Ambient Heat (39°C)

Water Spray and Fan OTHER

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.

Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C); Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (39°C); Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C); Burn Survivors (>40% Burn Surface Area) in Ambient Heat (39°C); Non-Burned Individuals in Ambient Heat (30°C); Non-Burned Individuals in Ambient Heat (39°C)

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 20-40% or \>40% 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
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

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

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Burns

Interventions

CCP110 protein, human

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Craig Crandall
• Organization: University of Texas Southwestern Medical Center

craigcrandall@texashealth.org

214-345-4623

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is required as each subject will be exposed to each cooling modality (e.g., fan only, skin wetting, and a combination of a fan and skin wetting).
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The investigators will conduct a randomized crossover design study. Burn survivors (20-40% burn surface area), burn survivors (\>40% burn surface area), and non-burned individuals will each perform four bouts of 60-min of exercise trials with the following cooling strategies: A) a control trial, B) skin wetting only trial, C) fan only trial, and D) a combination of skin wetting with a fan trial. Subjects will perform these four bouts under one of the following environmental conditions (30 deg C and 38 deg C). A subject will only be required to perform exercise across all four cooling modalities for a given environmental temperature (i.e., four exercise bouts); each will not be required to perform exercise across all combinations of environmental temperatures and cooling modalities (i.e., 12 exercise bouts).

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 14, 2020
• Study Start: January 15, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: July 28, 2025
• Results First Posted: October 21, 2024

Record last verified: 2025-07

Locations

US (1)