Computational Initiative for Performance Monitoring: Military Alerting System for Monitoring Body Temperature During Active Cooling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Thermal Sensation (TS)
研究概览
简要总结
BHSAI is developing a computational system that provides early alerts of a rise in core body temperature to help reduce the risk of heat injury in the field and during training. The goal of the body temperature alerting system is to use it during rest, exercise in the heat and during body cooling. Using this system during cooling will allow healthcare professionals and military personnel monitor core temperature to ensure cooling is effective (and prevent hypothermia). Therefore, the primary purpose of this investigation is to validate a body temperature alerting system using physiological responses that occur during rest, exercise in the heat and during body cooling. Multiple cooling modalities will be validated. The effectiveness of each cooling modality (passive cooling, mist-fan cooling, hand/forearm immersion) on physiological variables after exercise in the heat will be assessed. Lastly, subject characteristics (demographic and anthropometric characteristics) will be examined to examine their effect on physiological variables during exercise in the heat and during body cooling with each cooling modality.
详细描述
The study will be completed in the following timeline:
Visit 1: Baseline and VO2max Testing Visit 2-4: Trial 1, 2 and 3
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 7-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, iliac, tricep, calf, shoulder, 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. 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
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Cisgender man between the ages of 18-35 years
- •been cleared by the medical monitor for this 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, diuretics, NSAIDs, aspirin)
- •Identify as cisgender woman, transgender man or transgender woman
- •Have a history of heat related illness
结局指标
主要结局
Change in Thermal Sensation (TS)
时间窗: Measured every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)
0-8 Scale (cold to hot) that indicated how cold or hot the participate feels. 0 = extremely cold, 8 = extremely hot.
Change in Rectal Temperature
时间窗: Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)
Rectal thermometer will be self-inserted by participant to assess core temperature
Change in Heart Rate
时间窗: Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)
A heart rate monitor will be worn by participant throughout exercise/cooling protocol
Change in Perception of Thirst
时间窗: Measured every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 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 Mean Skin Temperature
时间窗: Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)
7 skin temperature sensors will be placed on the subject (neck, chest, shoulder,back, abdomen, thigh, calf)
Change in Rating of Perceived Exertion (RPE)
时间窗: Measured every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 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.
Environmental Symptoms
时间窗: After the 30 min cooling period in block 3
An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable)
Change in Perception of Fatigue
时间窗: Measured every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)
0-10 (no fatigue to extreme fatigue) Scale that indicates how fatigued the participate feels. High score indicates more fatigue (negative outcome).
次要结局
- POMS(Immediately following cooling period in block 3)
- Heart Rate Variability(Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes), then for 5 minutes 24 hours after)
- Purdue Peg Board test(immediately after cooling block 3)
- Digits Backwards(immediately following cooling block 3)
- Psychomotor Vigilance Test(immediately after cooling block 3)
- Digit Vigilance Test(immediately after cooling block 3)
- Trial Making Test(immediately after cooling block 3)
研究者
Douglas J Casa
Professor
University of Connecticut