Exercise in Burn Survivors: Cooling Modalities

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04512976
Study type	Interventional
Source	University of Texas Southwestern Medical Center
Contact
Status	Completed
Phase	N/A
Start date	January 15, 2021
Completion date	March 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT02241941` - Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury	Phase 4
Completed	`NCT02210208` - A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.	N/A
Completed	`NCT05063409` - Transfusion Ratio of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) During Burn Excision and Grafting	N/A
Completed	`NCT03730688` - Non-invasive Limb Compartment Pressure Measurement	N/A
Recruiting	`NCT04368117` - STAT: Standard Therapy Plus Active Therapy	N/A
Terminated	`NCT01773083` - Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma	Phase 3
Completed	`NCT02092701` - Effects of Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period	N/A
Recruiting	`NCT06263296` - Smartphone Assisted Self-management Education for Adult Burn Patient at Aftercare	N/A
Completed	`NCT02145130` - Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects	Phase 1
Completed	`NCT01618630` - Amino Acid Supplementation in Recovery From Severe Burns	N/A
Recruiting	`NCT05876442` - Efficacy of EPSW Plus HILT on Carpal Tunnel Syndrome Post Burn Injury	N/A
Completed	`NCT04417439` - The Effect of Acute Phase Treatment Approaches on Creatine Kinase and the Musculoskeletal System in Different Types of Burns
Completed	`NCT02417779` - Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy	N/A
Completed	`NCT02417818` - Cutaneous Microcirculation After Plasma Therapy	N/A
Completed	`NCT02417805` - Cutaneous Microcirculation After Remote Ischemic Preconditioning	N/A
Completed	`NCT01404026` - Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Due to Burn Injury	N/A
Completed	`NCT03204669` - Trace Element Repletion Following Severe Burn Injury	N/A
Recruiting	`NCT04947449` - Potential Benefits of Laser Treatment on Skin Blood Flow and Sweating in Burn Survivors
Not yet recruiting	`NCT05532488` - Inulin in Burn-induced Insulin Resistance	N/A
Recruiting	`NCT02189538` - Effect of n-3 PUFA From Fish in Enteral Nutrition of Major Burn Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.