Does Sildenafil Increase Exercise Performance in Air Pollution?

June 22, 2010 updated by: Marywood University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Scranton, Pennsylvania, United States, 18509
        • Marywood University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Subjects will exercise in a high air pollutant environment after ingesting a standard dose of sildenafil.
Drug: sildenafil
sildenafil 50 mg ingested orally 1 hour prior to exercise testing
Other Names:
  • Viagra
Active Comparator: 2
Subjects will exercise in a low pollutant environment after ingesting a standard dose of sildenafil.
Drug: sildenafil
sildenafil 50 mg ingested orally 1 hour prior to exercise testing
Other Names:
  • Viagra
Placebo Comparator: 3
Subjects will exercise in a high pollutant environment after ingesting a placebo.
Other: placebo
matching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing.
Other Names:
  • sugar pill
Placebo Comparator: 4
Subjects will exercise in a low pollutant environment after ingesting a placebo.
Other: placebo
matching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing.
Other Names:
  • sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Cycle ergometer testing will be done one hour after administration of sildenafil or matching placebo.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marywood University

Investigators

  • Principal Investigator: Kenneth W Rundell, Ph.D., Marywood University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

December 12, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (Estimate)

December 16, 2008

Study Record Updates

Last Update Posted (Estimate)

June 23, 2010

Last Update Submitted That Met QC Criteria

June 22, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU2007-028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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