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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01GM068865-13A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control (no cooling modalities) | Other | Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modality. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Temperature (°C) Following Control Intervention | The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. | At 60 minutes into the intervention. |
| Skin Temperature (°C) Following Fan Intervention |
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Inclusion Criteria (non-burned individuals):
Exclusion Criteria (non-burned individuals):
Inclusion Criteria (burn survivors):
Exclusion Criteria (burn survivors):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Exercise and Environmental Medincine - Texas Health Presbyterian Hospital Dallas | Dallas | Texas | 75231 | United States |
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70 subjects were enrolled in the study (signed the consent form). However, 5 of those subjects were screened out of the study during their consent visit due to elevated blood pressure (3), anxiety regarding the study procedures (1), and a body mass index higher than 35 (1).
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C) | 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. |
| FG001 | Experimental: Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (38°C) | Burn survivors with 20-40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (38°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. |
| FG002 | Experimental: Non-Burned Individuals in Ambient Heat (30°C) | 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. |
| FG003 | Experimental: Non-Burned Individuals in Ambient Heat (38°C) | Non-burned individuals will exercise for 60 minutes in ambient heat (38°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. |
| FG004 | Experimental: Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C) | 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. |
| FG005 | Experimental: Burn Survivors (>40% Burn Surface Area) in Ambient Heat (38°C) | Burn survivors with >40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (38°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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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65 subjects started this study, however, 3 were withdrawn prior to completing the study. Thus, our analyzed participant baseline information only includes 62 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C) | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | °C | At 0 minutes and 60 minutes into the intervention. |
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Adverse events were assessed throughout the 4 trial protocol for each subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C) | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig Crandall | University of Texas Southwestern Medical Center | 214-345-4623 | craigcrandall@texashealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2024 | May 20, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2024 | May 20, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C467559 | CCP110 protein, human |
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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).
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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).
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. |
| At 60 minutes into the intervention. |
| Skin Temperature (°C) Following Water-Spray Intervention | The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. | At 60 minutes into the intervention. |
| Skin Temperature (°C) Following Water-Spray and Fan Intervention | The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. | At 60 minutes into the intervention. |
| Heart Rate Following Control Intervention | The subject's heart rate will be measured from ECG electrodes attached to the participant. | At 60 minutes into the intervention. |
| Heart Rate Following Fan Intervention | The subject's heart rate will be measured from ECG electrodes attached to the participant. | At 60 minutes into the intervention. |
| Heart Rate Following Water-Spray Intervention | The subject's heart rate will be measured from ECG electrodes attached to the participant. | At 60 minutes into the intervention. |
| Heart Rate Following Water-Spray and Fan Intervention | The subject's heart rate will be measured from ECG electrodes attached to the participant. | At 60 minutes into the intervention. |
| Mean Arterial Blood Pressure Following Control 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) | At 60 minutes into the intervention. |
| Mean Arterial Blood Pressure Following Fan 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) | At 60 minutes into the intervention. |
| Mean Arterial Blood Pressure Following Water-Spray 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) | At 60 minutes into the intervention. |
| Mean Arterial Blood Pressure Following Water-Spray and Fan 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) | At 60 minutes into the intervention. |
| Experimental: Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (38°C) |
Burn survivors with 20-40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (38°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. |
| BG002 | Experimental: Non-Burned Individuals in Ambient Heat (30°C) | 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. |
| BG003 | Experimental: Non-Burned Individuals in Ambient Heat (38°C) | Non-burned individuals will exercise for 60 minutes in ambient heat (38°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. |
| BG004 | Experimental: Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C) | 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. |
| BG005 | Experimental: Burn Survivors (>40% Burn Surface Area) in Ambient Heat (38°C) | Burn survivors with >40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (38°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. |
| BG006 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body mass index | Mean | Standard Deviation | kg/m^2 |
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| OG002 | Non-Burned Individuals in Ambient Heat (30°C) | 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. |
| OG003 | Non-Burned Individuals in Ambient Heat (39°C) | 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. |
| OG004 | Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C) | 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. |
| OG005 | Burn Survivors (>40% Burn Surface Area) in Ambient Heat (39°C) | 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. |
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| Primary | 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. | Posted | Mean | Standard Deviation | °C | At 0 minutes and 60 minutes into the intervention. |
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| Primary | 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. | Posted | Mean | Standard Deviation | °C | At 0 minutes and 60 minutes into the intervention. |
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| Primary | 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. | Posted | Mean | Standard Deviation | °C | At 0 minutes and 60 minutes into the intervention. |
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| Secondary | Skin Temperature (°C) Following Control Intervention | The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. | Posted | Mean | Standard Deviation | °C | At 60 minutes into the intervention. |
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| Secondary | Skin Temperature (°C) Following Fan Intervention | The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. | Posted | Mean | Standard Deviation | °C | At 60 minutes into the intervention. |
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| Secondary | Skin Temperature (°C) Following Water-Spray Intervention | The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. | Posted | Mean | Standard Deviation | °C | At 60 minutes into the intervention. |
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| Secondary | Skin Temperature (°C) Following Water-Spray and Fan Intervention | The subject's skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. | Posted | Mean | Standard Deviation | °C | At 60 minutes into the intervention. |
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| Secondary | Heart Rate Following Control Intervention | The subject's heart rate will be measured from ECG electrodes attached to the participant. | Posted | Mean | Standard Deviation | beats per minute | At 60 minutes into the intervention. |
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| Secondary | Heart Rate Following Fan Intervention | The subject's heart rate will be measured from ECG electrodes attached to the participant. | Posted | Mean | Standard Deviation | beats per minute | At 60 minutes into the intervention. |
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| Secondary | Heart Rate Following Water-Spray Intervention | The subject's heart rate will be measured from ECG electrodes attached to the participant. | Posted | Mean | Standard Deviation | °C | At 60 minutes into the intervention. |
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| Secondary | Heart Rate Following Water-Spray and Fan Intervention | The subject's heart rate will be measured from ECG electrodes attached to the participant. | Posted | Mean | Standard Deviation | °C | At 60 minutes into the intervention. |
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| Secondary | Mean Arterial Blood Pressure Following Control 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) | Posted | Mean | Standard Deviation | mmHg | At 60 minutes into the intervention. |
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| Secondary | Mean Arterial Blood Pressure Following Fan 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) | Posted | Mean | Standard Deviation | mm Hg | At 60 minutes into the intervention. |
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| Secondary | Mean Arterial Blood Pressure Following Water-Spray 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) | Posted | Mean | Standard Deviation | mm Hg | At 60 minutes into the intervention. |
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| Secondary | Mean Arterial Blood Pressure Following Water-Spray and Fan 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) | Posted | Mean | Standard Deviation | mm Hg | At 60 minutes into the intervention. |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (38°C) | Burn survivors with 20-40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (38°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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Non-Burned Individuals in Ambient Heat (30°C) | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Non-Burned Individuals in Ambient Heat (38°C) | Non-burned individuals will exercise for 60 minutes in ambient heat (38°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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG004 | Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C) | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG005 | Burn Survivors (>40% Burn Surface Area) in Ambient Heat (38°C) | Burn survivors with >40% BSA (burn surface area) will exercise for 60 minutes in ambient heat (38°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. | 0 | 14 | 0 | 14 | 0 | 14 |
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