IEEM- Work:Rest Cycles in Burn Survivors- Humidity

The University of Texas System (UT)

Status: Enrolling

Conditions: Hyperthermia; Burn Injury

Study type: Observational

Funder types: Other

Identifiers

NCT06966336

STU20250255

Details and patient eligibility

About

The purpose of this project is to identify the effects of a severe burn injuries in humans on core temperature responses during work:rest cycles while in a heated environment.

Full description

Non-burned control participants and participants who experienced serious burns covering ≥20% of their body surface area will be investigated. Participants will undergo up to three work:rest cycles in the heat (via our environmental chamber) set to no higher than 40 °C. The work:rest cycle will comprise of 30 min of exercise that is followed by up to 20 min of rest, while staying in the heated conditions. Three consecutive work:rest cycles will be performed as illustrated in the protocol document. During one visit, this protocol will be performed in a low humidity state. During the other visit (randomized and crossover), this protocol will be performed in a high humidity state.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Non-burned Individuals:

• Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants must be between the ages of 18 and 65.

Exclusion Criteria for Non-burned Individuals:

• Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 3 years will be excluded. Participants may also be excluded if body mass index is ≥ 31 kg/m2 will likewise be excluded. Participants must not have had a serious burn injury requiring more than 1 night stay in the hospital.

Inclusion Criteria for Individuals with up to 40% of their body surface area burned (moderate burn group):

- Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants who have sustained a burn injury must have a burn covering 20-40% of their body surface area and 50% of those burns must be full-thickness burns requiring skin grafts. Participants must be between the ages of 18 and 65.

Exclusion Criteria for Individuals with up to 40% of their body surface area burned (moderate burn group):

- Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 3 years will be excluded. Participants may also be excluded if body mass index is ≥ 31 kg/m2 will likewise be excluded.

Inclusion Criteria for Individuals with greater than 40% of their body surface area burned (large burn group):

- Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants who have sustained a burn injury must have a burn covering more than 40% of their body surface area and 50% of those burns must be full-thickness burns requiring skin grafts. Participants must be between the ages of 18 and 65.

Exclusion Criteria for Individuals with greater than 40% of their body surface area burned (large burn group):

- Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 3 years will be excluded. Participants may also be excluded if body mass index is ≥ 31 kg/m2 will likewise be excluded.

Trial design

70 participants in 6 patient groups

Non-Burned Individuals in Low Humidity Environment

Description:

Non-burned individuals will perform up to three work:rest cycles in a heated environment with low humidity, with each work:rest cycle lasting up to 50 minutes.

Moderate Burned Individuals in Low Humidity Environment

Description:

Individuals with moderate sized burn injuries will perform up to three work:rest cycles in a heated environment with low humidity, with each work:rest cycle lasting up to 50 minutes.

Large Burned Individuals in Low Humidity Environment

Description:

Individuals with large sized burn injuries will perform up to three work:rest cycles in a heated environment with low humidity, with each work:rest cycle lasting up to 50 minutes.

Non-Burned Individuals in High Humidity Environment

Description:

Non-burned individuals will perform up to three work:rest cycles in a heated environment with high humidity, with each work:rest cycle lasting up to 50 minutes.

Moderate Burned Individuals in High Humidity Environment

Description:

Individuals with moderate sized burn injuries will perform up to three work:rest cycles in a heated environment with high humidity, with each work:rest cycle lasting up to 50 minutes.

Large Burned Individuals in HIgh Humidity Environment

Description:

Individuals with large sized burn injuries will perform up to three work:rest cycles in a heated environment with high humidity, with each work:rest cycle lasting up to 50 minutes.