NCT02432183

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

February 5, 2021

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

2.7 years

First QC Date

March 27, 2015

Results QC Date

August 12, 2019

Last Update Submit

December 19, 2023

Conditions

Keywords

individual

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Number of Participants With Allergies Determined by Positive Skin Prick Test

    baseline

Other Outcomes (1)

  • Number of Sputum Uric Acid-high Subjects (Determined by ELISA on Sputum Supernatants)

    baseline

Study Arms (4)

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).

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Elite athletes from the elite sport school in Wilrijk and Leuven
  • First grade of high school

You may not qualify if:

  • Performing \>4hours/week sports

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (3)

  • 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.

    PMID: 19346984BACKGROUND
  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

induced sputum sample and venous blood (serum)

Results Point of Contact

Title
Dominique MA Bullens
Organization
KU Leuven

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 27, 2015

First Posted

May 4, 2015

Study Start

September 1, 2012

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

January 10, 2024

Results First Posted

February 5, 2021

Record last verified: 2023-12

Locations