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临床试验/NCT03530163
NCT03530163已完成不适用

Breathing Training to Improve Human Performance at High Altitude

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2018年8月9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
28
试验地点
1
主要终点
Change in incidence and severity of acute mountain sickness during acute simulated high-altitude exposure as determined by the Lake Louise Questionnaire (a diagnostic survey of acute mountain sickness).

研究概览

简要总结

Individuals traveling to altitudes above 8,000 feet may suffer from impaired exercise and cognitive performance, and acute mountain sickness (AMS). Decreased barometric pressure, which leads to low blood oxygen levels, is the primary cause of these disorders. Symptoms of AMS are characterized by headache, nausea, vomiting, dizziness, fatigue, and difficulty sleeping. The goal of this research is to identify whether Respiratory Muscle Training will improve physical and cognitive performance, and reduce the symptoms of AMS, at simulated high altitude.

研究设计

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

盲法说明

Participants will be masked from knowing whether they are performing the Respiratory Muscle Training or sham training.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Men, ages 18-45 who are able to achieve at least 3.5 watts/kg of body weight during the peak oxygen uptake test

排除标准

  • •Less than 18 years old
  • •Greater than 45 years old
  • •Have a body mass index greater than or equal to 30
  • •Have been recent smokers (tobacco or e-cigarettes)
  • •Current recreational or medical marijuana users
  • •Currently taking any medication (over-the-counter or prescription) or herbal supplements
  • •Participants who are unable to tolerate drinking only two, 6-ounce caffeinated beverages per day of the study
  • •Participants who are legally blind
  • •Participants who have been to altitudes above Denver (1609m or 5280ft), including air travel, in the 3 weeks prior to the start of the study or with plans to do so during the study
  • •Participants who have suffered a significant head injury, have anemia or sickle cell trait or disease, have active peptic ulcer disease, diabetes, hypertension, heart disease, HIV/AIDS, glaucoma, kidney disease, liver disease/cirrhosis, adrenal gland failure, hyponatremia/hypokalemia, tuberculosis
  • •Participants who have a current herpes infection or any other current type of viral or bacterial infection
  • •Participants with seizure disorders or history of migraines

研究组 & 干预措施

Respiratory Muscle Training

Experimental

干预措施: Respiratory Muscle Training (Device)

Sham Breathing Training

Sham Comparator

干预措施: Sham Breathing Training (Device)

结局指标

主要结局

Change in incidence and severity of acute mountain sickness during acute simulated high-altitude exposure as determined by the Lake Louise Questionnaire (a diagnostic survey of acute mountain sickness).

时间窗: Baseline and during acute simulated high-altitude exposure. (2 days, 12 hours per day)

Determine whether Respiratory Muscle Training performed 3x a week for 30 minutes per session is effective in reducing incidence and severity of AMS during acute simulated high-altitude exposure.

Change in exercise performance during acute simulated high-altitude exposure as measured by a peak oxygen uptake test and time to complete a 720kJ (40km) time trial on a Velotron cycle ergometer.

时间窗: Baseline and during acute simulated high-altitude exposure. (2 days, 12 hours per day)

Determine whether Respiratory Muscle Training performed 3x a week for 30 minutes per session is effective in improving exercise performance during acute simulated high-altitude exposure.

Change in cognitive function during acute simulated high-altitude exposure as measured by the DANA cognitive test battery.

时间窗: Baseline and during acute simulated high-altitude exposure. (2 days, 12 hours per day)

Determine whether Respiratory Muscle Training performed 3x a week for 30 minutes per session improves cognitive function during simulated high-altitude exposure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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