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Completed

NCT Number: NCT00808912

Does Sildenafil Increase Exercise Performance in Air Pollution?

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.

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Key information

Conditions

Pulmonary Hypertension Air Pollution Cardiovascular Diseases Exercise Performance Hypertension Hypertension, Pulmonary Lung Diseases Pulmonary Artery Pressure Respiratory Tract Diseases Vascular Diseases

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Marywood University

Scranton, Pennsylvania, 18509, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

sildenafil 50 mg ingested orally 1 hour prior to exercise testing

Other names: Viagra

Placebo

Other

matching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing.

Other names: sugar pill

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. That the decreased VO2 peak and decreased exercise performance from emissions inhalation will be the result of pulmonary hypertension causing decreased stroke volume.

    Time frame: Pulmonary artery pressure will be measured before and immediately post exercise.

  2. That plasma and urine sildenafil and metabolites will be measurable by liquid chromatography mass spectrometry (LC/MS) 6 h post ingestion.

    Time frame: Blood and urine samples will be collected at 1, 3, 1nd 6 hours post exercise testing.

Sponsors and collaborators

Lead sponsor

Marywood University

Other

Registry information

Official study title

Decreased Pulmonary Artery Pressure by Oral Sildenafil Injection During Exercise in Air Pollution Increases Exercise Performance.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 16, 2008
Registry last updated
Jun 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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