N/A
N=65
Exercise in Burn Survivors: Cooling Modalities
Burn Injury
Bottom Line
View on ClinicalTrials.gov: NCT04512976 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Change in Core Temperature (°C) During Control Intervention — .578; .920; .622; .885 °C
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Control (no cooling modalities) (Other); Water Spray Only (Other); Fan Only (Other); Water Spray and Fan (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Core Temperature (°C) During Control Intervention |
.578; .920; .622; .885; .863; 1.29 | — |
| PRIMARY Change in Core Temperature (°C) During Fan Intervention |
.537; .996; .728; .891; .838; 1.135 | — |
| PRIMARY Change in Core Temperature (°C) During Water-Spray Intervention |
.511; .922; .726; .792; .787; .940 | — |
| PRIMARY Change in Core Temperature (°C) During Water-Spray and Fan Intervention |
.630; .869; .604; .928; .858; .928 | — |
| SECONDARY Skin Temperature (°C) Following Control Intervention |
33.204; 37.149; 30.978; 35.863; 34.092; 37.146 | — |
| SECONDARY Skin Temperature (°C) Following Fan Intervention |
32.787; 37.660; 30.396; 33.911; 32.819; 37.146 | — |
| SECONDARY Skin Temperature (°C) Following Water-Spray Intervention |
29.114; 34.332; 29.110; 32.879; 28.65; 33.549 | — |
| SECONDARY Skin Temperature (°C) Following Water-Spray and Fan Intervention |
28.727; 34.406; 27.276; 32.659; 26.958; 34.661 | — |
| SECONDARY Heart Rate Following Control Intervention |
113; 128; 110; 118; 117; 142 | — |
| SECONDARY Heart Rate Following Fan Intervention |
114; 133; 106; 125; 113; 136 | — |
| SECONDARY Heart Rate Following Water-Spray Intervention |
113; 132; 112; 118; 113; 130 | — |
| SECONDARY Heart Rate Following Water-Spray and Fan Intervention |
112; 129; 107; 120; 112; 128 | — |
| SECONDARY Mean Arterial Blood Pressure Following Control Intervention |
89; 86; 86; 83; 100; 97 | — |
| SECONDARY Mean Arterial Blood Pressure Following Fan Intervention |
94; 94; 89; 86; 97; 89 | — |
| SECONDARY Mean Arterial Blood Pressure Following Water-Spray Intervention |
91; 96; 82; 82; 104; 96 | — |
| SECONDARY Mean Arterial Blood Pressure Following Water-Spray and Fan Intervention |
94; 88; 90; 84; 95; 92 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04512976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.