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临床试验/NCT04512976
NCT04512976已完成不适用

Exercise in Burn Survivors: Cooling Modalities

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Change in Core Temperature (°C) During Control Intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

盲法说明

No masking is required as each subject will be exposed to each cooling modality (e.g., fan only, skin wetting, and a combination of a fan and skin wetting).

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Core Temperature (°C) During Control Intervention

时间窗: At 0 minutes and 60 minutes into the intervention.

The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.

Change in Core Temperature (°C) During Fan Intervention

时间窗: At 0 minutes and 60 minutes into the intervention.

The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.

Change in Core Temperature (°C) During Water-Spray Intervention

时间窗: At 0 minutes and 60 minutes into the intervention.

The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.

Change in Core Temperature (°C) During Water-Spray and Fan Intervention

时间窗: At 0 minutes and 60 minutes into the intervention.

The subject's core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill.

次要结局

  • Skin Temperature (°C) Following Control Intervention(At 60 minutes into the intervention.)
  • Skin Temperature (°C) Following Fan Intervention(At 60 minutes into the intervention.)
  • Skin Temperature (°C) Following Water-Spray Intervention(At 60 minutes into the intervention.)
  • Skin Temperature (°C) Following Water-Spray and Fan Intervention(At 60 minutes into the intervention.)
  • Heart Rate Following Control Intervention(At 60 minutes into the intervention.)
  • Heart Rate Following Fan Intervention(At 60 minutes into the intervention.)
  • Heart Rate Following Water-Spray Intervention(At 60 minutes into the intervention.)
  • Heart Rate Following Water-Spray and Fan Intervention(At 60 minutes into the intervention.)
  • Mean Arterial Blood Pressure Following Control Intervention(At 60 minutes into the intervention.)
  • Mean Arterial Blood Pressure Following Fan Intervention(At 60 minutes into the intervention.)
  • Mean Arterial Blood Pressure Following Water-Spray Intervention(At 60 minutes into the intervention.)
  • Mean Arterial Blood Pressure Following Water-Spray and Fan Intervention(At 60 minutes into the intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Craig Crandall

Professor

University of Texas Southwestern Medical Center

研究点 (2)

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