Physiological and Thermoregulatory Responses of Body Cooling During Cycling in a Hot Environment (PYTHON)
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 Mean Skin temperature
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. This study is expanding on a previous intervention IRB#H20-0010 (BHSAI Cooling Study), but will examine body cooling during more intense exercise and while cycling. We will also examine the effectiveness of each cooling modality (passive cooling, mist-fan cooling, hand/forearm immersion, ice towel) on physiological variables after exercise in the heat.
详细描述
Design
The study will be completed in the following timeline:
Visit 1: Baseline and VO2max Testing
Vist 2: Metabolic Heat Production Visit
Visit 3-6: Trial 1, 2 ,3, 4
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 28 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Cisgender man between the ages of 18-28 years
- •been cleared by the medical monitor for this study
- •VO2max > 45ml/kg/min
- •Aerobically active (at least 30 minutes of aerobic exercise 4-5 days 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, or respiratory disease
- •A family member died for no apparent reason, had a heart attack, died from heart problems, or sudden death before the age of 50
- •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. Cisgender women, Transgender men, and transgender women are excluded from the current study because the sponsor of the study has requested that this testing be done in physically active cisgender males. It is assumed that they either currently have data on women or transgender women/men to compare this to or have a strategic initiative from a marketing or business perspective that only involves cisgender men.
- •Have a history of heat related illness
- •Throat or gastroesophageal diseases including gastroesophageal reflux disease (aka, GERD) or difficulty swallowing
- •Have any allergies or adverse reactions to the cold (e.g. Cold Uticaria, Raynauds Phenomenon/Disease, or Cryoglobulinanemia)
结局指标
主要结局
Change in Mean Skin temperature
时间窗: Measured continuously during two, 40 min exercise blocks and 2 20-30 min cooling periods
Prior to the start of exercise, participants will be instrumented with 9-site (Biopac) and 6-site skin temperature (iButton) sensors. The Biopac skin temperature sensors will be placed on the chest, shoulder, forearm, abdomen, neck, back, thigh and anterior calf and posterior calf. and the iButton skin temperature sensors will be placed on the chest, arm, thigh, and anterior calf and posterior calf.
Change in Rating of Perceived Exertion
时间窗: Every 10 minutes of the exercise blocks (2 x 40 mins) and cooling period (2 x 20-30 min)
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.
Difference in VO2max between Cycle ergometer and treadmill
时间窗: At the end of exercise test for both cycle ergometer and treadmill
Participants will be fitted with a Hans Rudolph mask attached to a breathing tube to measure the expired air delivered to the metabolic cart system during the exercise protocol. The metabolic cart will continuously measure oxygen consumption (VO2) to asess their VO2max value.
Metabolic Heat Production
时间窗: Will be measured continuously throughout the 25 min exercise protocol.
Participants will be tested for 3-5 minutes at different % of their VO2max. It will include 5 stages.
Change in Rectal Temperature
时间窗: Measured continuously during two, 40 min exercise blocks and 2 20-30 min cooling periods.
Rectal thermometer will be self-inserted by participant to assess core temperature
Change in Esophageal Temperature
时间窗: Measured continuously during two, 40 min exercise blocks and 2 20-30 min cooling periods
Esophageal thermometer will be inserted by a researcher to assess core temperature
Change in Heart Rate
时间窗: Measured continuously during two, 40 min exercise blocks and 2 20-30 min cooling periods
A heart rate monitor will be worn by participant throughout exercise/cooling protocol
次要结局
- Change in Perception of Fatigue(Every 10 minutes of the exercise blocks (2 x 40 mins) and cooling period (2 x 20-30 min))
- Change in Perception of thirst(Every 10 minutes of the exercise blocks (2 x 40 mins) and cooling period (2 x 20-30 min))
- Change in Thermal Sensation(Every 10 minutes of the exercise blocks (2 x 40 mins) and cooling period (2 x 20-30 min))
研究者
Douglas J Casa
Professor
University of Connecticut