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Exercise in Burn Survivors: Cooling Modalities

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ClinicalTrials.gov Identifier: NCT04512976
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Craig Crandall, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Burn Injury Other: Cooing Modalities Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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).
Primary Purpose: Prevention
Official Title: Exercise in Burn Survivors: Cooling Modalities
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 24 deg C environment
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.
Other: Cooing Modalities

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.


Experimental: 30 deg C environment
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.
Other: Cooing Modalities

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.


Experimental: 38 deg C environment
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.
Other: Cooing Modalities

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 Measures :
  1. Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill. [ Time Frame: Prior to and throughout each bout of exercise; an average of 120 minutes. ]
    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 :
  1. Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. [ Time Frame: Prior to and throughout each bout of exercise; an average of 120 minutes. ]
    During exercise, one's skin temperature will increase. This device will measure this increase in skin temperature throughout the exercise.

  2. Heart rate will be measured from ECG electrodes attached to the participant. [ Time Frame: Prior to and throughout each bout of exercise; an average of 120 minutes. ]
    During exercise, one's heart rate will increase. This device will measure this increase in heart rate throughout the exercise.

  3. Arterial blood pressure will be measured using a standard arm blood pressure cuff. [ Time Frame: Prior to and throughout each bout of exercise; an average of 120 minutes. ]
    During exercise, one's blood pressure will increase. This device will measure this increase in blood pressure throughout the exercise.

  4. Cardiac output (how much blood is ejected from the heart) will be measured using a nitrous oxide rebreathing approach. [ Time Frame: Prior to and throughout each bout of exercise; an average of 120 minutes. ]
    During exercise, one's cardiac output will increase. This device will measure this increase in cardiac output throughout the exercise.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512976


Contacts
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Contact: Frank Cimino, MS 214-345-7112 frankcimino@texashealth.org
Contact: Amy Slack-Bryant 214-345-8740 amybryant@texashealth.org

Locations
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United States, Texas
Institute for Exercise and Environmental Medincine - Texas Health Presbyterian Hospital Dallas Recruiting
Dallas, Texas, United States, 75231
Contact: Bonnie Orth, MS    214-345-6502    BonnieDOrth@texashealth.org   
Contact: Frank Cimino, MS    214-345-7112    frankCimino@texashealth.org   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Responsible Party: Craig Crandall, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04512976    
Other Study ID Numbers: STU_2020_0334
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Craig Crandall, University of Texas Southwestern Medical Center:
skin graft
thermoregulation
burn survivor
3rd degree burn injury
human
Additional relevant MeSH terms:
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Burns
Wounds and Injuries