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In this study the investigators will study the lung function and airway inflammation in elite athletes starting at the elite sport school (age: 12-13 year) and the change in lung function parameters and airway inflammation after 1 and 2 years at the elite sport school in comparison to age-matched controls (exercising at a recreational level, <4 hours/week).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Football players | Football players of the first grade of high school are recruited from the topsportschool in Leuven. | ||
| Basketball players | Basketball players of the first grade of high school are recruited from the topsportschool in Leuven. | ||
| Swimmers | Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation | ||
| Control group | Age-matched controls are recruited (exercising at a recreational level, >4 hours). |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximal Fall in Forced Expiratory Volume in One-second (FEV1) After Eucapnic Voluntary Hyperventilation (EVH) Test | 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. | change from baseline compared to 15 minutes after EVH test |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Allergies Determined by Positive Skin Prick Test | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sputum Uric Acid-high Subjects (Determined by ELISA on Sputum Supernatants) | number of subjets with sputum uric acid level above p90 in controls | baseline |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Vlaams Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19346984 | Background | 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. | |
| 26790574 | Result |
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As we did not anticipate a gender imbalance in the study groups, control subjects were recruited based on age-match not on sex-match. To correct for the gender imbalance, we added nine control subjects to the control group.
total number of control subjects is increased compared to protocol enrollment to compensate for gender imbalance
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| ID | Title | Description |
|---|---|---|
| FG000 | Football Players | Football players of the first grade of high school are recruited from the topsportschool in Leuven. |
| FG001 | Swimmers | Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation |
| FG002 | Basketball Players | Basketball players of the first grade of high school are recruited from the topsportschool in Leuven. |
| FG003 | Control Group | Age-matched controls are recruited (exercising at a recreational level, >4 hours). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Football Players | Football players of the first grade of high school are recruited from the topsportschool in Leuven. |
| BG001 | Swimmers | Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximal Fall in Forced Expiratory Volume in One-second (FEV1) After Eucapnic Voluntary Hyperventilation (EVH) Test | 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. | EVH test not correctly performed (according to measure description) in 11 subjects (5 football players, 4 basket ball players and 2 swimmers) and hence 11 subjects here excluded from analysis | Posted | Median | Inter-Quartile Range | percentage of change in FEV1 after EVH | change from baseline compared to 15 minutes after EVH test |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Football Players | Football players of the first grade of high school are recruited from the topsportschool in Leuven. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dominique MA Bullens | KU Leuven | 3216341338 | dominique.bullens@kuleuven.be |
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induced sputum sample and venous blood (serum)
| 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. |
| 29908073 | Result | 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. |
| BG002 | Basketball Players | Basketball players of the first grade of high school are recruited from the topsportschool in Leuven. |
| BG003 | Control Group | Age-matched controls are recruited (exercising at a recreational level, >4 hours). |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Football Players | Football players of the first grade of high school are recruited from the topsportschool in Leuven. |
| OG001 | Basketball Players | Basketball players of the first grade of high school are recruited from the topsportschool in Leuven. |
| OG002 | Swimmers | Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation |
| OG003 | Control Group | Age-matched controls are recruited (exercising at a recreational level, >4 hours). |
|
|
|
| Secondary | Number of Participants With Allergies Determined by Positive Skin Prick Test | Posted | Number | participants | baseline |
|
|
|
| Other Pre-specified | Number of Sputum Uric Acid-high Subjects (Determined by ELISA on Sputum Supernatants) | number of subjets with sputum uric acid level above p90 in controls | Sputum not available in 21 subjects due to technical issues (10 football players, 7 basket ball players, and 4 swimmers) and hence excluded from this analysis | Posted | Number | participants | baseline |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Swimmers | Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation | 0 | 47 | 0 | 47 |
| EG002 | Basketball Players | Basketball players of the first grade of high school are recruited from the topsportschool in Leuven. | 0 | 26 | 0 | 26 |
| EG003 | Control Group | Age-matched controls are recruited (exercising at a recreational level, >4 hours). | 0 | 17 | 0 | 17 |
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