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Exercise in Burn Survivors: Cooling Modalities

Primary Purpose

Burn Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cooing Modalities

About this trial

This is an interventional prevention trial for Burn Injury focused on measuring skin graft, thermoregulation, burn survivor, 3rd degree burn injury, human

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 20-40% 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

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

24 deg C environment

30 deg C environment

38 deg C environment

Arm Description

Subjects will exercise for 60 minutes in a 24 deg C environment 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.

Outcomes

Primary Outcome Measures

Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.

During exercise, one's core body temperature will increase. This device will measure this increase in core body temperature throughout the exercise.

Secondary Outcome Measures

Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.

During exercise, one's skin temperature will increase. This device will measure this increase in skin temperature throughout the exercise.

Heart rate will be measured from ECG electrodes attached to the participant.

During exercise, one's heart rate will increase. This device will measure this increase in heart rate throughout the exercise.

Arterial blood pressure will be measured using a standard arm blood pressure cuff.

During exercise, one's blood pressure will increase. This device will measure this increase in blood pressure throughout the exercise.

Cardiac output (how much blood is ejected from the heart) will be measured using a nitrous oxide rebreathing approach.

During exercise, one's cardiac output will increase. This device will measure this increase in cardiac output throughout the exercise.

Full Information

NCT ID

NCT04512976

First Posted

August 10, 2020

Last Updated

March 27, 2023

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04512976

Brief Title

Exercise in Burn Survivors: Cooling Modalities

Official Title

Exercise in Burn Survivors: Cooling Modalities

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

January 15, 2021 (Actual)

Primary Completion Date

March 1, 2023 (Actual)

Study Completion Date

March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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 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, with and without accompanying fan use, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burn Injury

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

The investigators will conduct a randomized crossover design study. Burn survivors and non-burned individuals, will each perform four bouts of 60-min of exercise trials with each bout incorporating the following cooling strategy: 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 (24 deg C, 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).

Masking

None (Open Label)

Masking Description

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).

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

24 deg C environment

Arm Type

Experimental

Arm Description

Arm Title

30 deg C environment

Arm Type

Experimental

Arm Description

Arm Title

38 deg C environment

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Cooing Modalities

Intervention Description

Subjects will exercise for 60 minutes in the indicated environmental condition 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. A 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 well-healed grafted skin throughout the exercise bout. A combination of a fan and skin wetting will be performed by simultaneously applying both cooling modalities throughout the exercise bout.

Primary Outcome Measure Information:

Title

Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.

Description

During exercise, one's core body temperature will increase. This device will measure this increase in core body temperature throughout the exercise.

Time Frame

Prior to and throughout each bout of exercise; an average of 120 minutes.

Secondary Outcome Measure Information:

Title

Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.

Description

During exercise, one's skin temperature will increase. This device will measure this increase in skin temperature throughout the exercise.

Time Frame

Prior to and throughout each bout of exercise; an average of 120 minutes.

Title

Heart rate will be measured from ECG electrodes attached to the participant.

Description

During exercise, one's heart rate will increase. This device will measure this increase in heart rate throughout the exercise.

Time Frame

Prior to and throughout each bout of exercise; an average of 120 minutes.

Title

Arterial blood pressure will be measured using a standard arm blood pressure cuff.

Description

During exercise, one's blood pressure will increase. This device will measure this increase in blood pressure throughout the exercise.

Time Frame

Prior to and throughout each bout of exercise; an average of 120 minutes.

Title

Cardiac output (how much blood is ejected from the heart) will be measured using a nitrous oxide rebreathing approach.

Description

During exercise, one's cardiac output will increase. This device will measure this increase in cardiac output throughout the exercise.

Time Frame

Prior to and throughout each bout of exercise; an average of 120 minutes.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 20-40% 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 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

Facility Information:

Facility Name

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

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Exercise in Burn Survivors: Cooling Modalities

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