Elite Athlete, Healthy
Conditions
Keywords
individual
Brief summary
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).
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.
Interventions
None listed
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
11 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Elite athletes from the elite sport school in Wilrijk and Leuven * First grade of high school
Exclusion criteria
* Performing \>4hours/week sports
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Fall in Forced Expiratory Volume in One-second (FEV1) After Eucapnic Voluntary Hyperventilation (EVH) Test | change from baseline compared to 15 minutes after 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. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Allergies Determined by Positive Skin Prick Test | baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Sputum Uric Acid-high Subjects (Determined by ELISA on Sputum Supernatants) | baseline | number of subjets with sputum uric acid level above p90 in controls |
Countries
Belgium
Participant flow
Recruitment details
total number of control subjects is increased compared to protocol enrollment to compensate for gender imbalance
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Football Players Football players of the first grade of high school are recruited from the topsportschool in Leuven. | 44 |
| Swimmers Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation | 47 |
| Basketball Players Basketball players of the first grade of high school are recruited from the topsportschool in Leuven. | 26 |
| Control Group Age-matched controls are recruited (exercising at a recreational level, \>4 hours). | 17 |
| Total | 134 |
Baseline characteristics
| Characteristic | Swimmers | Basketball Players | Football Players | Control Group | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 47 Participants | 26 Participants | 44 Participants | 17 Participants | 134 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.1 years STANDARD_DEVIATION 0.8 | 12.2 years STANDARD_DEVIATION 0.6 | 13.1 years STANDARD_DEVIATION 0.9 | 12.9 years STANDARD_DEVIATION 1.8 | 12.5 years STANDARD_DEVIATION 0.7 |
| Region of Enrollment Belgium | 47 participants | 26 participants | 44 participants | 17 participants | 134 participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 7 Participants | 12 Participants | 42 Participants |
| Sex: Female, Male Male | 36 Participants | 14 Participants | 37 Participants | 5 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 47 | 0 / 26 | 0 / 17 |
| serious Total, serious adverse events | 0 / 44 | 0 / 47 | 0 / 26 | 0 / 17 |
Outcome results
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.
Time frame: change from baseline compared to 15 minutes after EVH test
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Football Players | Maximal Fall in Forced Expiratory Volume in One-second (FEV1) After Eucapnic Voluntary Hyperventilation (EVH) Test | -4 percentage of change in FEV1 after EVH |
| Basketball Players | Maximal Fall in Forced Expiratory Volume in One-second (FEV1) After Eucapnic Voluntary Hyperventilation (EVH) Test | -9 percentage of change in FEV1 after EVH |
| Swimmers | Maximal Fall in Forced Expiratory Volume in One-second (FEV1) After Eucapnic Voluntary Hyperventilation (EVH) Test | -9 percentage of change in FEV1 after EVH |
| Control Group | Maximal Fall in Forced Expiratory Volume in One-second (FEV1) After Eucapnic Voluntary Hyperventilation (EVH) Test | -5 percentage of change in FEV1 after EVH |
p-value: 0.0061Kruskal-Wallis
Secondary
Number of Participants With Allergies Determined by Positive Skin Prick Test
Time frame: baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Football Players | Number of Participants With Allergies Determined by Positive Skin Prick Test | 14 participants |
| Basketball Players | Number of Participants With Allergies Determined by Positive Skin Prick Test | 6 participants |
| Swimmers | Number of Participants With Allergies Determined by Positive Skin Prick Test | 19 participants |
| Control Group | Number of Participants With Allergies Determined by Positive Skin Prick Test | 4 participants |
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
Time frame: baseline
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Football Players | Number of Sputum Uric Acid-high Subjects (Determined by ELISA on Sputum Supernatants) | 15 participants |
| Basketball Players | Number of Sputum Uric Acid-high Subjects (Determined by ELISA on Sputum Supernatants) | 15 participants |
| Swimmers | Number of Sputum Uric Acid-high Subjects (Determined by ELISA on Sputum Supernatants) | 26 participants |
| Control Group | Number of Sputum Uric Acid-high Subjects (Determined by ELISA on Sputum Supernatants) | 3 participants |