- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02432183
Longitudinal Follow-up of High School Athletes
Longitudinal Follow-up of Exercise-induced Bronchoconstriction and Airway Inflammation in High School Athletes
Study Overview
Status
Conditions
Detailed Description
A group of elite athletes (from the elite sport school in Leuven (n=35) in cooperation with 'Sportmedisch Advies Centrum' (SMAC) UZ Leuven) and the future team of the Flemish Swimming Federation (n=15) will be recruited at the start of their career (first level) as an elite athlete. A group of healthy subjects (n=20) will be recruited to serve as a control.
The investigators will compare lung function parameters and airway inflammation at the first visit in the autumn of 2011 and the second and third visit (one and two years later, respectively).
Lung function will be assessed by spirometry. Sputum will be induced with an aerosol of inhaled hypertonic saline in concentrations of 3%, 4% and 5% for 7 minutes generated by a De Vilbiss nebuliser (Ultra-Neb 2000 model 200HI) after pretreatment with 400 mg inhaled salbutamol. Sputum will be processed as previously described and the obtained cell suspensions will be used for differential cell counts and cytokine mRNA analysis. The supernatant will be used to measure cytokine and chemokine levels.
EIA diagnosis (visit 1,2 and 3) will be assessed by a diagnostic test for asthma (positive reversibility test with salbutamol) and a positive EIB-test. Eucapnic voluntary hyperventilation test will be used as a test for EIB (gold standard of IOC-MC). Dynamic lung function parameters will be assessed before and immediately after, 5' after, 10' after and 15' after eucapnic hyperventilation. Patients were asked to breath at 85% of the maximal ventilation (predefined as maximal voluntary volume) for 6 minutes through a mouthpiece connected to a reservoir. The reservoir is be filled with a gas mixture of 21% 02, 5% CO2 and 74% N2. The test is considered positive when a drop in FEV1 of >10% occurred at one of the time points after eucapnic hyperventilation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vlaams Brabant
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Leuven, Vlaams Brabant, Belgium, 3000
- UZ Leuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
A group of elite athletes at the start of their career (both from the elite sport school in Wilrijk (n=15) and Leuven (n=35) in cooperation with 'Sportmedisch Advies Centrum' (SMAC) UZ Leuven) are recruited. Three sport disciplines are included: basketball players, football players and swimmers.
A group of healthy subjects (n=20) is recruited to serve as a control.
Description
Inclusion Criteria:
- Elite athletes from the elite sport school in Wilrijk and Leuven
- First grade of high school
Exclusion Criteria:
- Performing >4hours/week sports
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Football players
Football players of the first grade of high school are recruited from the topsportschool in Leuven.
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Basketball players
Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.
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Swimmers
Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation
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Control group
Age-matched controls are recruited (exercising at a recreational level, >4 hours).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal Fall in Forced Expiratory Volume in One-second (FEV1) After Eucapnic Voluntary Hyperventilation (EVH) Test
Time Frame: change from baseline compared to 15 minutes after EVH test
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percentage change in FEV1 after EHV test compared to baseline EVH test will be performed for 6 min at a target ventilation of 85% of the maximal voluntary ventilation (MVV), which will be determined before initiation of the test.
Ventilation will be monitored during the 6-min test by a flow sensor (Jaeger Oxycon Mobile, Carefusion), FEV1 will be measured immediately after challenge and at 5, 10 and 15 min.
A reduction in FEV1 ≥ 10% at one of the time points compared with the value before the test will be considered positive.
Salbutamol (400 μg) will be given after the last spirometry (post-EVH) to check bronchodilator reversibility.
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change from baseline compared to 15 minutes after EVH test
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Allergies Determined by Positive Skin Prick Test
Time Frame: baseline
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baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Sputum Uric Acid-high Subjects (Determined by ELISA on Sputum Supernatants)
Time Frame: baseline
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number of subjets with sputum uric acid level above p90 in controls
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baseline
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Collaborators and Investigators
Publications and helpful links
General Publications
- Bonini M, Braido F, Baiardini I, Del Giacco S, Gramiccioni C, Manara M, Tagliapietra G, Scardigno A, Sargentini V, Brozzi M, Rasi G, Bonini S. AQUA: Allergy Questionnaire for Athletes. Development and validation. Med Sci Sports Exerc. 2009 May;41(5):1034-41. doi: 10.1249/MSS.0b013e318193c663.
- Van der Eycken S, Schelpe A, Marijsse G, Dilissen E, Troosters T, Vanbelle V, Aertgeerts S, Dupont LJ, Peers K, Bullens DM, Seys SF. Feasibility to apply eucapnic voluntary hyperventilation in young elite athletes. Respir Med. 2016 Feb;111:91-3. doi: 10.1016/j.rmed.2015.12.012. Epub 2016 Jan 4.
- Jonckheere AC, Seys SF, Dilissen E, Marijsse G, Schelpe AS, Van der Eycken S, Verhalle T, Vanbelle V, Aertgeerts S, Troosters T, Peers K, Dupont LJ, Bullens DMA. AQUA(c) Questionnaire as prediction tool for atopy in young elite athletes. Pediatr Allergy Immunol. 2018 Sep;29(6):648-650. doi: 10.1111/pai.12949. Epub 2018 Jul 9. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- S53448
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