Exercise in Burn Survivors: Cooling Modalities

Not Applicable

Completed

• Conditions: Burn Injury
• Interventions: Other: Cooing Modalities

• Registration Number: NCT04512976
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-14
• Study Start: 2021-01-15
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Results First Submitted: 2024-05-20
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-18
• Results First Posted: 2024-10-21
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
24 deg C environment	Cooing Modalities	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.
38 deg C environment	Cooing Modalities	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.
30 deg C environment	Cooing Modalities	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.

Primary Outcome Measures

Name	Time	Method
Change in Core Temperature (°C) During Control Intervention	At 0 minutes and 60 minutes into the intervention.	The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.
Change in Core Temperature (°C) During Fan Intervention	At 0 minutes and 60 minutes into the intervention.	The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.
Change in Core Temperature (°C) During Water-Spray Intervention	At 0 minutes and 60 minutes into the intervention.	The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.
Change in Core Temperature (°C) During Water-Spray and Fan Intervention	At 0 minutes and 60 minutes into the intervention.	The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.

Secondary Outcome Measures

Name	Time	Method
Skin Temperature (°C) Following Control Intervention	At 60 minutes into the intervention.	The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.
Skin Temperature (°C) Following Fan Intervention	At 60 minutes into the intervention.	The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.
Skin Temperature (°C) Following Water-Spray Intervention	At 60 minutes into the intervention.	The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.
Skin Temperature (°C) Following Water-Spray and Fan Intervention	At 60 minutes into the intervention.	The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin.
Heart Rate Following Control Intervention	At 60 minutes into the intervention.	The subject's heart rate will be measured from ECG electrodes attached to the participant.
Heart Rate Following Fan Intervention	At 60 minutes into the intervention.	The subject's heart rate will be measured from ECG electrodes attached to the participant.
Heart Rate Following Water-Spray Intervention	At 60 minutes into the intervention.	The subject's heart rate will be measured from ECG electrodes attached to the participant.
Heart Rate Following Water-Spray and Fan Intervention	At 60 minutes into the intervention.	The subject's heart rate will be measured from ECG electrodes attached to the participant.
Mean Arterial Blood Pressure Following Control Intervention	At 60 minutes into the 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)
Mean Arterial Blood Pressure Following Fan Intervention	At 60 minutes into the 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)
Mean Arterial Blood Pressure Following Water-Spray Intervention	At 60 minutes into the 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)
Mean Arterial Blood Pressure Following Water-Spray and Fan Intervention	At 60 minutes into the 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)

Trial Locations

Locations (1)

Institute for Exercise and Environmental Medincine - Texas Health Presbyterian Hospital Dallas; 🇺🇸 Dallas, Texas, United States