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临床试验/NCT04257266
NCT04257266撤回不适用

The Effect of 5-site Ice Pack Cooling on Body Temperature, Skin Temperature, and Heart Rate After Exercise-induced Hyperthermia

University of Connecticut0 个研究点开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Change in Esophageal Temperature

研究概览

简要总结

This research study aims to examine whether Cryo Cooling packs reduce thermal and cardiovascular strain after exercise-induced hyperthermia compared to a commercially available ice pack. Secondly, the effect of Cryo Cooling packs on cognitive and exercise performance will be examined. There is no current research examining the efficacy of Cryo Cooling packs in hyperthermic individuals and this information will be helpful to establish whether Cryo Cooling Packs can be used for performance enhancement or to prevent heat illness.

详细描述

This study will consist of three study visits:

Visit 1: Baseline and VO2max Testing Visit 2-3: Trial 1 and 2.

Visit 1: Baseline and VO2max Testing

Participants who are approved to participate will be scheduled for a baseline and VO2max testing day. Upon arrival to the lab, subjects will provide a urine sample in a clean urine cup. Urine specific gravity and urine color will be assessed. Nude body mass will be also be recorded. Privacy will be afforded for each participant while obtaining body mass measures by taking measurements with the participant alone in a private room behind a solid, closed door, and the research reading the scale outside of the room. Participants will only be permitted to continue to the VO2max test if the euhydrated criteria of a urine specific gravity (USG) ≤1.025 is met. If the participant arrives with a USG between 1.020 and 1.025, the subject will be asked to drink 500 mL of water to ensure proper hydration status. Height will be measured with a tape measure on Visit 1. Percent body fat will be calculated using a 3-site evaluation of skin fold thickness using skin fold calipers on one of the three baseline days. A researcher will use appropriate grasping technique to measure skin fold thickness on the chest, abdomen, and thigh. This will take less than ~5 minutes to complete. This information will be used to describe the subject demographics. Participants will also be asked to complete a maximal oxygen uptake (VO2max) test on a treadmill in a thermoneutral environment. This test will provide aerobic fitness levels of the participants.

Visit 2-3: Trials 1 and 2

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The participant will be blinded to which ice pack will be used during the intervention.

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Between the ages of 18-30 years
  • been cleared by the medical monitor for this study

排除标准

  • Have a current musculoskeletal injury that would limit their physical activity or preclude the participant from walking, jogging, running, sprinting, or cutting.
  • Chronic health problems that affect your ability to thermoregulate (disorders affecting the liver, kidneys or the ability to sweat normally)
  • Fever or current illness at the time of testing
  • History of cardiovascular, metabolic, or respiratory disease
  • Current musculoskeletal injury that limits their physical activity
  • Currently taking a medication that is known to influence body temperature (amphetamines, antihypertensives, anticholinergics, acetaminophen, diuretics, NSAIDs, aspirin)
  • Are a female
  • Have a history of heat related illness
  • Throat or gastroesophageal diseases including gastroesophageal reflux disease (aka, GERD) or difficulty swallowing

结局指标

主要结局

Change in Esophageal Temperature

时间窗: Measured continuously for 2-3 hours during exercise and cooling period

Esophageal thermometer will be inserted by trained personnel to assess core temperature

Change in Heart rate

时间窗: Measured continuously for 2-3 hours during exercise and cooling period

A heart rate monitor will be worn by participant throughout exercise/cooling protocol

Change in Perception of Thirst

时间窗: Collected every 5 minutes during 2-3 hour exercise and cool down period.

0-9 (no thirst to very,very thirsty) Scale that indicates how thirsty the participant is

Change in Rectal Temperature

时间窗: Measured continuously for 2-3 hours during exercise and cooling period

Rectal thermometer will be self-inserted by participant to assess core temperature

Change in Rating of Perceived Exertion

时间窗: Collected every 5 minutes during 2-3 hour exercise and cool down period.

6-20 scale that indicates how hard the participant feels they are working

Change in Thermal Sensation

时间窗: Collected every 5 minutes during 2-3 hour exercise and cool down period.

0-8 Scale (cold to hot) that indicated how cold or hot the participate feels

Change in Skin Temperature

时间窗: Measured continuously for 2-3 hours during exercise and cooling period

4 skin temperature sensors will be placed on the subject (chest, shoulder, thigh, calf) during exercise and the cooling intervention

Change in Perception of Fatigue

时间窗: Collected every 5 minutes during 2-3 hour exercise and cool down period.

0-10 (no fatigue to extreme fatigue) Scale that indicates how fatigued the participate feels

次要结局

  • Profile of Mood States(immediately following cooling intervention)
  • Digits Backwards(immediately after cooling intervention)
  • Reaction time test(immediately after cooling intervention)
  • 1 Mile run(immediately following Cooling)
  • Grip strength: Hand Grip Dynamometer(immediately following cooling)

研究者

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

Douglas J Casa

Professor

University of Connecticut

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