Study of Airway Inflammation in Relation to Exercise in Elite Athletes

July 12, 2018 updated by: Dominque Bullens, Universitaire Ziekenhuizen KU Leuven
High school elite training programs are today more and more under development in several 'elite sport schools' in Belgium, in order to select and train future elite athletes already at young age. Little is known about the effects of sustained training on the potential development of asthma in adolescents during lung growth. It would be of great importance to be able to select the individuals at risk to develop exercise-induced asthma, already at the start of their enrollment in the 'elite sport school. This would allow physicians to follow their lung function parameters very closely and regularly; and, if necessary, start treatment early after the first signs of exercise-induced asthma.

Study Overview

Status

Completed

Detailed Description

Competitive swimmers, competitive indoor athletes and control individuals performing sports at a recreational level will be recruited for the study.

They will perform a sport-specific training (swimmers and controls: swimming for 90 minutes, indoor athletes: basketball or volleyball for 90 minutes)

Baseline measurements:

  • Airway inflammation upper and lower airways will be assessed by collection of nasal fluid (nasal sponge will be inserted in nostril for 5 minutes), Fraction of exhaled Nitric Oxide measurement and sputum induction.
  • Upper and lower airway symptoms will be assessed by questionnaires (SinoNasal Outcome Measure-22, Visual Analogue Score, Asthma Symptom Score and Juniper Score)
  • Allergy will be assessed by skin prick test (on skin) and immunocap test (in blood, 1 tube of 10 ml).
  • Lung function and nasal patency will be measured by spirometry and Peak Nasal Inspiratory Flow measurement.
  • Exercise induced bronchoconstriction will be assessed by eucapnic voluntary hyperventilation test.

Measurements immediately after training:

  • Collection of nasal fluid
  • Assessment of upper airway symptoms (Visual Analogue Score)
  • Spirometry and Fraction of Exhaled Nitric Oxide measurement
  • Peak Nasal Inspiratory Flow measurement

Measurements 24 hours after training:

  • Collection of nasal fluid
  • Assessment of upper airway symptoms (Visual Analogue Score)
  • Spirometry and Fraction of Exhaled Nitric Oxide measurement
  • Peak Nasal Inspiratory Flow measurement
  • Sputum induction
  • Venous puncture (1 tube of 10 ml)

Study Type

Observational

Enrollment (Actual)

66

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

    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven

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

14 years to 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Competitive swimmers, competitive indoor athletes and healthy individuals

Description

Inclusion Criteria:

  • Performing sports at national or international level (swimmers and indoor athletes)

Exclusion Criteria:

  • Performing sport at recreational level (not more than 4 hours/week for healthy individuals)

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

Cohorts and Interventions

Group / Cohort
Competitive swimmers
Swimmers performing at national or international level
Competitive indoor athletes
Indoor athletes performing at national or international level
Healthy control individuals
Individuals performing sports at a recreational level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of airway inflammation
Time Frame: Baseline, immediately after and 24 hours after sport-specific training
Airway inflammation upper and lower airways will be assessed by collection of nasal fluid (nasal sponge will be inserted in nostril for 5 minutes), Fraction of exhaled Nitric Oxide measurement and sputum induction.
Baseline, immediately after and 24 hours after sport-specific training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of exercise induced bronchoconstriction
Time Frame: baseline
Exercise induced bronchoconstriction will be assessed by eucapnic voluntary hyperventilation test.
baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of allergy
Time Frame: baseline
-Allergy will be assessed by skin prick test (on skin) and immunocap test (in blood, 1 tube of 10 ml).
baseline
Assessment of upper and lower airway symptoms
Time Frame: Baseline, immediately after and 24 hours after sport-specific training
-Upper and lower airway symptoms will be assessed by questionnaires (SinoNasal Outcome Measure-22, Visual Analogue Score, Asthma Symptom Score and Juniper Score)
Baseline, immediately after and 24 hours after sport-specific training
Measurement of lung function and nasal patency
Time Frame: at baseline, immediately after and 24 hours sport-specific training
-Lung function and nasal patency will be measured by spirometry and Peak Nasal Inspiratory Flow measurement.
at baseline, immediately after and 24 hours sport-specific training

Collaborators and Investigators

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

Investigators

  • Study Director: Sven F Seys, MSc, lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven
  • Study Director: Valerie Hox, MD, lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Overall results are presented in a closed session for participants and parents. Confidential individual data are afterwards discussed with the respective parents and participants.

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.

Clinical Trials on Exercise Induced Asthma

Subscribe