Exercise in Burn Survivors: Cooling Modalities

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04512976

Enrollment

Registered

2020-08-14

Start date

2021-01-15

Completion date

2023-03-01

Last updated

2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Injury

Keywords

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

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.

Interventions

OTHERWater Spray and Fan

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.

OTHERControl (no cooling modalities)

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

OTHERWater Spray Only

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.

OTHERFan Only

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

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).

Intervention model description

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).

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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)
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)
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.

Countries

United States

Participant flow

Pre-assignment details

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).

Participants by arm

Arm	Count
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.	11
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.	10
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.	10
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.	10
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.	10
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.	11
Total	62

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Overall Study	Unable to complete the exercise protocols in the study.	0	0	0	0	0	3

Baseline characteristics

Characteristic	Experimental: Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (38°C)	Experimental: Non-Burned Individuals in Ambient Heat (30°C)	Experimental: Non-Burned Individuals in Ambient Heat (38°C)	Experimental: Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C)	Experimental: Burn Survivors (>40% Burn Surface Area) in Ambient Heat (38°C)	Experimental: Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C)	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	10 Participants	10 Participants	10 Participants	10 Participants	11 Participants	11 Participants	62 Participants
Body mass index	25.76 kg/m^2 STANDARD_DEVIATION 3.64	23.57 kg/m^2 STANDARD_DEVIATION 1.89	23.85 kg/m^2 STANDARD_DEVIATION 1.97	27.77 kg/m^2 STANDARD_DEVIATION 3.45	27.12 kg/m^2 STANDARD_DEVIATION 2.62	25.48 kg/m^2 STANDARD_DEVIATION 3.86	25 kg/m^2 STANDARD_DEVIATION 3
Race/Ethnicity, Customized African American/Black	3 Participants	1 Participants	2 Participants	1 Participants	3 Participants	3 Participants	13 Participants
Race/Ethnicity, Customized Asian	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized Hispanic	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	7 Participants
Race/Ethnicity, Customized Non-Hispanic	9 Participants	8 Participants	9 Participants	9 Participants	10 Participants	10 Participants	55 Participants
Race/Ethnicity, Customized White	7 Participants	9 Participants	8 Participants	8 Participants	7 Participants	8 Participants	47 Participants
Sex: Female, Male Female	5 Participants	5 Participants	5 Participants	5 Participants	5 Participants	6 Participants	31 Participants
Sex: Female, Male Male	5 Participants	5 Participants	5 Participants	5 Participants	6 Participants	5 Participants	31 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 11	0 / 10	0 / 10	0 / 10	0 / 10	0 / 14
other Total, other adverse events	0 / 11	0 / 10	0 / 10	0 / 10	0 / 10	0 / 14
serious Total, serious adverse events	0 / 11	0 / 10	0 / 10	0 / 10	0 / 10	0 / 14

Outcome results

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.

Time frame: At 0 minutes and 60 minutes into the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C)	Change in Core Temperature (°C) During Control Intervention	.578 °C	Standard Deviation 0.27
Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (39°C)	Change in Core Temperature (°C) During Control Intervention	.920 °C	Standard Deviation 0.432
Non-Burned Individuals in Ambient Heat (30°C)	Change in Core Temperature (°C) During Control Intervention	.622 °C	Standard Deviation 0.205
Non-Burned Individuals in Ambient Heat (39°C)	Change in Core Temperature (°C) During Control Intervention	.885 °C	Standard Deviation 0.404
Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C)	Change in Core Temperature (°C) During Control Intervention	.863 °C	Standard Deviation 0.449
Burn Survivors (>40% Burn Surface Area) in Ambient Heat (39°C)	Change in Core Temperature (°C) During Control Intervention	1.29 °C	Standard Deviation 0.58

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.

Time frame: At 0 minutes and 60 minutes into the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C)	Change in Core Temperature (°C) During Fan Intervention	.537 °C	Standard Deviation 0.195
Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (39°C)	Change in Core Temperature (°C) During Fan Intervention	.996 °C	Standard Deviation 0.654
Non-Burned Individuals in Ambient Heat (30°C)	Change in Core Temperature (°C) During Fan Intervention	.728 °C	Standard Deviation 0.318
Non-Burned Individuals in Ambient Heat (39°C)	Change in Core Temperature (°C) During Fan Intervention	.891 °C	Standard Deviation 0.267
Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C)	Change in Core Temperature (°C) During Fan Intervention	.838 °C	Standard Deviation 0.463
Burn Survivors (>40% Burn Surface Area) in Ambient Heat (39°C)	Change in Core Temperature (°C) During Fan Intervention	1.135 °C	Standard Deviation 0.565

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.

Time frame: At 0 minutes and 60 minutes into the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C)	Change in Core Temperature (°C) During Water-Spray and Fan Intervention	.630 °C	Standard Deviation 0.26
Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (39°C)	Change in Core Temperature (°C) During Water-Spray and Fan Intervention	.869 °C	Standard Deviation 0.354
Non-Burned Individuals in Ambient Heat (30°C)	Change in Core Temperature (°C) During Water-Spray and Fan Intervention	.604 °C	Standard Deviation 0.285
Non-Burned Individuals in Ambient Heat (39°C)	Change in Core Temperature (°C) During Water-Spray and Fan Intervention	.928 °C	Standard Deviation 0.347
Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C)	Change in Core Temperature (°C) During Water-Spray and Fan Intervention	.858 °C	Standard Deviation 0.331
Burn Survivors (>40% Burn Surface Area) in Ambient Heat (39°C)	Change in Core Temperature (°C) During Water-Spray and Fan Intervention	.928 °C	Standard Deviation 0.453

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.

Time frame: At 0 minutes and 60 minutes into the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (30°C)	Change in Core Temperature (°C) During Water-Spray Intervention	.511 °C	Standard Deviation 0.224
Burn Survivors (20-40% Burn Surface Area) in Ambient Heat (39°C)	Change in Core Temperature (°C) During Water-Spray Intervention	.922 °C	Standard Deviation 0.289
Non-Burned Individuals in Ambient Heat (30°C)	Change in Core Temperature (°C) During Water-Spray Intervention	.726 °C	Standard Deviation 0.222
Non-Burned Individuals in Ambient Heat (39°C)	Change in Core Temperature (°C) During Water-Spray Intervention	.792 °C	Standard Deviation 0.372
Burn Survivors (>40% Burn Surface Area) in Ambient Heat (30°C)	Change in Core Temperature (°C) During Water-Spray Intervention	.787 °C	Standard Deviation 0.294
Burn Survivors (>40% Burn Surface Area) in Ambient Heat (39°C)	Change in Core Temperature (°C) During Water-Spray Intervention	.940 °C	Standard Deviation 0.488

Secondary