Does Sildenafil Increase Exercise Performance in Air Pollution?

Not Applicable

Completed

• Conditions: Pulmonary Hypertension; Pulmonary Artery Pressure; Exercise Performance; Air Pollution
• Interventions: Drug: sildenafil; Other: placebo

• Registration Number: NCT00808912
• Lead Sponsor: Marywood University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-15
• Study First Posted: 2008-12-16
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-22
• Last Update Posted: 2010-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• non-asthmatic
• asthmatic
• active participants in endurance sports.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	sildenafil	Subjects will exercise in a high air pollutant environment after ingesting a standard dose of sildenafil.
2	sildenafil	Subjects will exercise in a low pollutant environment after ingesting a standard dose of sildenafil.
3	placebo	Subjects will exercise in a high pollutant environment after ingesting a placebo.
4	placebo	Subjects will exercise in a low pollutant environment after ingesting a placebo.

Primary Outcome Measures

Name	Time	Method
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.	Cycle ergometer testing will be done one hour after administration of sildenafil or matching placebo.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Marywood University; 🇺🇸 Scranton, Pennsylvania, United States