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临床试验/NCT04596618
NCT04596618已完成不适用

Impact of Forearm Immersion Cooling Equipment (ICE) on Exercise Performance in the Heat

University of Connecticut1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Change in Perception of Thirst

研究概览

简要总结

The purpose of this study is to determine the effects of intermittent forearm cooling on exercise performance in the heat.

详细描述

The study will be completed in the following timeline:

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

Visit specific information is described below, however, specific data collection protocols for dependent variables and procedures are included below the description of the study design.

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. A researcher will use appropriate grasping technique to measure skin fold thickness on the chest, tricep, and abdomen. 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. This visit will take approximately 1-2 hours.

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
None

入排标准

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

入选标准

  • •Cisgender male between the ages of 18-30 years
  • •been cleared by the medical monitor for the study
  • •VO2max >45ml/kg/min

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, NSAIDs, aspirin)
  • •Are a female
  • •Have a history of heat related illness
  • •Have any cold allergies or adverse reactions to the cold (i.e. cold urticaria, Raynaud's, cryoglobulinemia)

研究组 & 干预措施

Forearm Cooling

Active Comparator

Participants will be actively cooled during rest breaks.

干预措施: Forearm cooling (Device)

No Forearm Cooling

No Intervention

Participants will participant in "passive cooling" where they sit in a chair during rest.

结局指标

主要结局

Change in Perception of Thirst

时间窗: Measured every 5 minutes during the duration of the trial (total 150 minutes)

0-9 (no thirst to extreme thirst) Scale that indicates how thirsty the subject feels. A higher score is considered a negative outcome.

Change in Rectal Temperature

时间窗: Measured continuously during the duration of the trial (total 150 minutes)

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

Change in Esophageal Temperature

时间窗: Measured continuously during the duration of the trial (total 150 minutes)

An esophageal thermometer will be inserted by the researchers to assess participants esophageal temperature.

Change in Rating of Perceived Exertion (RPE)

时间窗: Measured every 5 minutes during the duration of the trial (total 150 minutes)

6-20 scale that indicates how hard the participant feels they are working. 6 represents rest and 20 represents maximal exertion. A high score indicates more perceived exertion.

Broad Jump

时间窗: after the quick-board agility, at time point 153minutes

Participants will attempt to jump as far forward as they can 3 times, measured in centimeters.

Change in Perception of Fatigue

时间窗: Measured every 5 minutes during the duration of the trial (total 150 minutes)

0-10 (no fatigue to extreme fatigue) Scale that indicates how fatigued the participate feels. High score indicates more fatigue (negative outcome).

Environmental Symptoms

时间窗: After completion of the performance battery, at time point 180min.

An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable) with the scale ranging from Not at all, a little, somewhat, moderate, a lot, to extreme.

Quick-Board Agility

时间窗: After the end of 3min cooling period block 6

Agility will be assessed by number of foot taps within 10seconds and then number of hops within 10seconds.

Grip Strength

时间窗: after the Broad jump test, at time point 155minutes

Participants will squeeze a hand held dynamometer 3 times, measured in kilograms

Sprints

时间窗: after the grip strength test, at time point 160minutes

On a non-motorized treadmill, participants will sprint for 6sec followed by 24sec of rest, repeat 3 times, belt revolutions will be measured.

Metabolic heat production

时间窗: Measured during the last 5 minutes of each exercise block for a total of six measurements for a total of 36minutes.

Using a metabolic mask and metabolic cart, metabolic heat production will be collected.

Change in Mean Skin Temperature

时间窗: Measured continuously during the duration of the trial (total 150 minutes)

4 skin temperature sensors will be placed on the subject (chest, shoulder, thigh, calf)

Change in Heart Rate

时间窗: Measured continuously during the duration of the trial (total 150 minutes)

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

Change in Thermal Sensation (TS)

时间窗: Measured every 5 minutes during the duration of the trial (total 150 minutes)

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

One Mile Timed Trial

时间窗: after the sprint test, at time point 170minutes

On a motorized treadmill, participants will run at a self-selected pace until they run a distance of 1-mile, time measured in minutes

Environmental Symptoms

时间窗: Before the start of exercise block 1

An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable) with the scale ranging from Not at all, a little, somewhat, moderate, a lot, to extreme.

次要结局

未报告次要终点

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

研究点 (1)

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