IEEM- Work:Rest Cycles in Burn Survivors- Humidity

Recruiting

• Conditions: Hyperthermia; Burn Injury

• Registration Number: NCT06966336
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-02
• Study First Posted: 2025-05-11
• Status Verified: 2025-08
• Study Start: 2025-08-15
• Last Update Submitted: 2025-08-19
• Last Update Posted: 2025-08-26
• Primary Completion: 2030-08-01
• Study Completion: 2031-08-01

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in core temperature	From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes.	Change in core body temperature will be measured either from a temperature sensor pill or from a rectal thermometer.

Secondary Outcome Measures

Name	Time	Method
Change in Heart Rate	From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes.	Heart rate will be measured from ECG electrodes attached to the participant.

Trial Locations

Locations (1)

IEEM Texas Health Presbyterian Hospital Dallas; 🇺🇸 Dallas, Texas, United States