Burn Injury Clinical Trial
Official title:
Exercise in Burn Survivors: Cooling Modalities
Verified date | March 2023 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | March 1, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 Exclusion Criteria (burn survivors): - 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 - Extensive unhealed injured skin |
Country | Name | City | State |
---|---|---|---|
United States | Institute for Exercise and Environmental Medincine - Texas Health Presbyterian Hospital Dallas | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill. | During exercise, one's core body temperature will increase. This device will measure this increase in core body temperature throughout the exercise. | Prior to and throughout each bout of exercise; an average of 120 minutes. | |
Secondary | Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. | During exercise, one's skin temperature will increase. This device will measure this increase in skin temperature throughout the exercise. | Prior to and throughout each bout of exercise; an average of 120 minutes. | |
Secondary | Heart rate will be measured from ECG electrodes attached to the participant. | During exercise, one's heart rate will increase. This device will measure this increase in heart rate throughout the exercise. | Prior to and throughout each bout of exercise; an average of 120 minutes. | |
Secondary | Arterial blood pressure will be measured using a standard arm blood pressure cuff. | During exercise, one's blood pressure will increase. This device will measure this increase in blood pressure throughout the exercise. | Prior to and throughout each bout of exercise; an average of 120 minutes. | |
Secondary | Cardiac output (how much blood is ejected from the heart) will be measured using a nitrous oxide rebreathing approach. | During exercise, one's cardiac output will increase. This device will measure this increase in cardiac output throughout the exercise. | Prior to and throughout each bout of exercise; an average of 120 minutes. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02210208 -
A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.
|
N/A | |
Withdrawn |
NCT02241941 -
Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
|
Phase 4 | |
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 |
NCT02417818 -
Cutaneous Microcirculation After Plasma Therapy
|
N/A | |
Completed |
NCT02417779 -
Cutaneous Microcirculation After Extracorporeal Shock Wave 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 |