Comparison of Bi-environmental Conditions During Occupational Related Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in Blood Lactate
研究概览
简要总结
BHSAI is developing a computational system that provides early alerts of a rise and fall in core body temperature to help reduce the risk of thermal 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 cold. 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 cold. Multiple cold ambient temperatures will be validated.
详细描述
Each participant will perform 5 study visits: 1) baseline testing and four trials.
Participant numbers will be randomly assigned. Four trials for men (extreme cold, EC; Moderate Cold, MoC; mild cold, MiC; extreme heat, EH) and four trials for women (EC-follicular phase, EC-F; EC- luteal phase, EC-L; EH-F; EH-F) will be ordered with a random number generator and assigned to a participant number. These orders will be counterbalanced between participants to ensure that there is not an order effect. Participants will be assigned after medical clearance is granted. 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. Participants will be asked to sign a photo/video release form (Appendix H) to be used in research projects, scientific publications/conferences and for educational purposes. Participants may be videoed or photographed while exercising or resting in the environmental chamber.
Baseline Testing (visit 1)
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between the ages of 18-28 years
- •been cleared by the medical monitor for this study
- •Must perform aerobic exercise for 150 minutes per week.
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, respiratory disease, peripheral arterial disease, or coagulopathy
- •Current musculoskeletal injury that limits their physical activity
- •Currently taking a medication that is known to influence body temperature or blood flow (amphetamines, antihypertensives, anticholinergics, acetaminophen, diuretics, NSAIDs, aspirin, vasoactive medications)
- •Have a history of heat related illness
- •Have a history of cold urticaria (i.e. allergy to the cold) and/or Raynaud's phenomenon [disorder that causes decreased blood flow to peripheral body parts (e.g. fingers and toes)]
- •Currently smoking (cigarettes, vaporizers, e-cigarettes)
结局指标
主要结局
Change in Blood Lactate
时间窗: Collected every 10 mins during last exercise block (exercise block 3) and post-exercise block (total for 4 time points)
a finger stick blood sample equivalent to 1 drop of blood (0.7μ1) will be taken to analyze lactate concentration with a portable analyzer at baseline, at predetermined intervals during exercise, and once during the post-exercise rest periods.
Change in Rating of Perceived Exertion
时间窗: Measured every 10 minutes in rest period (1.5-2.5 hours) and exercise (2 hour).
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.
Change in Rectal Temperature
时间窗: Measured continuously for rest block (1.5-2.5 hours) and exercise 2 hour).
Rectal thermometer will be self-inserted by participant to assess core temperature
Change in esophageal temperature
时间窗: Measured continuously for rest block (1.5-2.5 hours) and exercise (2 hour).
Esophageal thermometer will be inserted by researchers to assess core temperature
Change in Mean Skin temperature
时间窗: Measured continuously for rest block (1.5-2.5 hours) and exercise (2 hour).
14 sites with Biopac sensors and 4 sites with iButtonsResearchers will apply the skin temperature sensors with medical tape to the participants' finger tip and base of finger, hand dorsum, forearm, thigh, calf, feet dorsum, big toe, nose, cheek, ear tip, chin, and forehead. The participant will also be instrumented with 4 iButton skin temp sensors (thigh, calf, chest, shoulder).
Change in Heart rate
时间窗: Measured continuously for rest block (1.5-2.5 hours) and exercise (2 hour).
A heart rate monitor will be worn by participant throughout rest/exercise protocol
Change in Blood Flow
时间窗: Measured 3 data collection points(every 10-15 min) every following each exercise block for all three exercise blocks (total of 3 recovery time points)
Blood flow will be measured using a portable Triplex ultrasound device using Doppler imaging (GE Logiq E, Soma Technology, Bloomfield, CT). Measurements will be taken at 6 predetermined locations (brachial, radial, ulnar, femoral, anterior tibial, and posterior tibial arteries) at distinct anatomical sites
次要结局
- Oxygen saturation(Measured 3 data collection points(every 10-15 min) every following each exercise block for all three exercise blocks (total of 3 recovery time points))
- Heart rate variability(Measured continuously for rest block (1.5-2.5 hours) and exercise (1 hour).)
- Change in Thermal Sensation(Measured every 10 minutes in rest period (1.5-2.5 hours) and exercise (2 hour).)
- Change in Perception of Fatigue(Measured every 10 minutes in rest period (1.5-2.5 hours) and exercise (2 hour).)
- Change in Perception of Thirst(Measured every 10 minutes in rest period (1.5-2.5 hours) and exercise (2 hour).)
研究者
Douglas J Casa
Professor
University of Connecticut