Decreased Pulmonary Artery Pressure by Oral Sildenafil Injection During Exercise in Air Pollution Increases Exercise Performance.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- That a decrease in exercise performance subsequent to emissions particle inhalation will be blunted by oral ingestion of 50 mg sildenafil prior to a 6-min maximal accumulation test (total kJ)on a cycle ergometer.
研究概览
简要总结
The purpose of this study is to examine if the ingestion of a standard dose of sildenafil enhances the athletic performance of competitive athletes when exercising in a high pollutant environment verses a low air pollutant environment.
详细描述
This study will evaluate effects of sildenafil on exercise performance while breathing high levels of emission exhaust ultrafine and fine particulate matter. Exercise performance will be measured by work accumulation (total kJ) during a 6-min maximal effort cycle ergometer ride (CER) done immediately after 30 min cycling at 75% of 6 min mean watts determined from familiarization trial. Peak oxygen consumption, cardiac output, pulmonary artery pressure, diffusion capacity(DLco), and SaO2 will be determined for each trial. Blood and urine will be analyzed for sildenafil using LC/MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •non-asthmatic
- •asthmatic
- •active participants in endurance sports.
排除标准
- •history of high blood pressure
- •history of heart disease
- •pulmonary arterial hypertension
- •pulmonary emboli
- •diagnosis of moderate to severe asthma (FEV1 <75% predicted)
- •pregnant or lactating
研究组 & 干预措施
1
Subjects will exercise in a high air pollutant environment after ingesting a standard dose of sildenafil.
干预措施: sildenafil (Drug)
2
Subjects will exercise in a low pollutant environment after ingesting a standard dose of sildenafil.
干预措施: sildenafil (Drug)
3
Subjects will exercise in a high pollutant environment after ingesting a placebo.
干预措施: placebo (Other)
4
Subjects will exercise in a low pollutant environment after ingesting a placebo.
干预措施: placebo (Other)
结局指标
主要结局
That a decrease in exercise performance subsequent to emissions particle inhalation will be blunted by oral ingestion of 50 mg sildenafil prior to a 6-min maximal accumulation test (total kJ)on a cycle ergometer.
时间窗: Cycle ergometer testing will be done one hour after administration of sildenafil or matching placebo.
次要结局
- That the decreased VO2 peak and decreased exercise performance from emissions inhalation will be the result of pulmonary hypertension causing decreased stroke volume.(Pulmonary artery pressure will be measured before and immediately post exercise.)
- That plasma and urine sildenafil and metabolites will be measurable by liquid chromatography mass spectrometry (LC/MS) 6 h post ingestion.(Blood and urine samples will be collected at 1, 3, 1nd 6 hours post exercise testing.)