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Recruiting NCT07050264

The Effect of Simulated Burn Injury on Post Exercise Recovery in Hot Environments

No phase Interventional Burn Injury Body Temperature Regulation Cardiovascular Physiology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Simulated burn injury via application of absorbent and impermeable material over 60% of the body.
Who it may be relevant to
Registry conditions: Burn Injury, Body Temperature Regulation, Cardiovascular Physiology. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Burn survivors have difficulty thermoregulating due to reduced skin blood flow and sweating responses at the grafted sites. It has been previously shown that this impaired heat dissipation results in burn survivors experiencing higher core temperatures for a given exercise/environmental exposure compared to non-burned individuals. This also holds true with the use of simulated burn injury. When an absorbent material is applied to the skin over a desired amount of body surface area, it replicates a burn injury of the same size (i.e., simulated burn injury). A question that remains unknown is if this impaired thermoregulation in burn survivors would affect post-exercise core temperature recovery, i.e., do burn survivors recover slower than non-burned individuals upon stopping exercise. To that end, the primary objective of this project is to determine the rate at which body temperature and other markers of thermoregulation recover after a bout of exercise in the heat and if this response is different in the same individual with and without simulated burn injury.

Interventions

  • Other Simulated burn injury via application of absorbent and impermeable material over 60% of the body
    Simulated burn injury via application of absorbent and impermeable material over 60% of the body

Primary outcome measures

  • Core Temperature [Time frame: From baseline to end of 60 minutes of recovery]
Secondary outcome measures (1)
  • Heart Rate [Time frame: From baseline to the end of 60 minutes of recovery]

Eligibility criteria

Inclusion criteria

  • 18 and 65 years of age
  • free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram.

Exclusion criteria

  • Known heart disease
  • other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, etc. as well as serious abnormalities detected on routine screening.
  • Individuals who are pregnant, planning to become pregnant, or breastfeeding will be excluded, this will be confirmed in females using a urine pregnancy test.
  • Taking prescribed medications (such as beta blockers and non-dihydropyridine calcium channel blockers) or over-the-counter medications that have known influences on thermoregulatory response.
  • Current smokers, as well as individuals who regularly smoked within the past 3 years.
  • body mass index is ≥ 31 kg/m2.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dal — Dallas

Identifiers

NCT: NCT07050264 · STU20251344 · R35GM152112-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗