Elite AthleteNCT02432183
Longitudinal Follow-up of High School Athletes
An observational study of Elite Athlete and Healthy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Elite Athlete, Healthy
- How many people
- 134 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2012to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Elite athletes from the elite sport school in Wilrijk and Leuven
- First grade of high school
Who cannot join
- Performing >4hours/week sports
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Follow-up of Exercise-induced Bronchoconstriction and Airway Inflammation in High School Athletes
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).
Read the 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.
- Conditions
- Elite Athlete, Healthy
- Keywords
- individual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline compared to 15 minutes after EVH test
Secondary outcomes (1)
Number of Participants With Allergies Determined by Positive Skin Prick Test
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startSep 2012
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Elite AthleteStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominque Bullens, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432183
- Sponsor's protocol ID
- S53448
- Status last verified
- Dec 2023
- First submitted
- 27 Mar 2015
- Last updated
- 10 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 19346984Van 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.
PubMed 26790574Jonckheere 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.
PubMed 29908073
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Follow-up of Exercise-induced Bronchoconstriction and Airway Inflammation in High School Athletes
- ClinicalTrials.gov ID
- NCT02432183
- Acronym / sponsor ID
- S53448
- Conditions
- Elite Athlete, Healthy
- Keywords
- individual
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Posted 5 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Elite athletes from the elite sport school in Wilrijk and Leuven
- First grade of high school
Key exclusion criteria (1 listed)
- Performing >4hours/week sports
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
1 secondary outcome
Number of Participants With Allergies Determined by Positive Skin Prick Test
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19346984Bonini 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.
- Results publication: PubMed 26790574Van 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.
- Results publication: PubMed 29908073Jonckheere 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elite Athlete and Healthy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02432183, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.