Longitudinal Follow-up of High School Athletes

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Completed
• CT.gov ID: NCT02432183
• Collaborator: (none)
• Enrollment: 134
• Location: 1
• Duration (Months): 39
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Elite Athlete; Healthy

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

• Study Type: Observational
• Actual Enrollment: 134 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Longitudinal Follow-up of Exercise-induced Bronchoconstriction and Airway Inflammation in High School Athletes
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

1. 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 as described in "Feasibility to apply eucapnic voluntary hyperventilation in young elite athletes. Van der Eycken S et al, Respir Med. 2016 Feb;111:91-3."

Secondary Outcome Measures

1. Number of Participants With Allergies Determined by Positive Skin Prick Test [baseline]

Other Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven	Vlaams Brabant	Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Dominque Bullens, Prof. Dr., Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT02432183
• Other Study ID Numbers: S53448
• First Posted: May 4, 2015
• Last Update Posted: Feb 5, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Dominque Bullens, Prof. Dr., Universitaire Ziekenhuizen Leuven: individual

Study Results

Participant Flow

Recruitment Details	total number of control subjects is increased compared to protocol enrollment to compensate for gender imbalance
Pre-assignment Detail	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.

Arm/Group Title	Football Players	Swimmers	Basketball Players	Control Group
Arm/Group Description	Football players of the first grade of high school are recruited from the topsportschool in Leuven.	Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation	Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.	Age-matched controls are recruited (exercising at a recreational level, >4 hours).
Period Title: Overall Study
STARTED	44	47	26	17
COMPLETED	44	47	26	17
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Football Players	Swimmers	Basketball Players	Control Group	Total
Arm/Group Description	Football players of the first grade of high school are recruited from the topsportschool in Leuven.	Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation	Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.	Age-matched controls are recruited (exercising at a recreational level, >4 hours).	Total of all reporting groups
Overall Participants	44	47	26	17	134
Age (Count of Participants)
<=18 years	44 100%	47 100%	26 100%	17 100%	134 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	13.1 (0.9)	12.1 (0.8)	12.2 (0.6)	12.9 (1.8)	12.5 (0.7)
Sex: Female, Male (Count of Participants)
Female	7 15.9%	11 23.4%	12 46.2%	12 70.6%	42 31.3%
Male	37 84.1%	36 76.6%	14 53.8%	5 29.4%	92 68.7%
Region of Enrollment (participants) [Number]
Belgium	44 100%	47 100%	26 100%	17 100%	134 100%

Outcome Measures

1. Primary Outcome

Title	Maximal Fall in Forced Expiratory Volume in One-second (FEV1) After Eucapnic Voluntary Hyperventilation (EVH) Test
Description	percentage change in FEV1 after EHV test compared to baseline EVH test will be performed as described in "Feasibility to apply eucapnic voluntary hyperventilation in young elite athletes. Van der Eycken S et al, Respir Med. 2016 Feb;111:91-3."
Time Frame	change from baseline compared to 15 minutes after EVH test

Outcome Measure Data

Analysis Population Description

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/Group Title	Football Players	Basketball Players	Swimmers	Control Group
Arm/Group Description	Football players of the first grade of high school are recruited from the topsportschool in Leuven.	Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.	Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation	Age-matched controls are recruited (exercising at a recreational level, >4 hours).
Measure Participants	39	22	45	17
Median (Inter-Quartile Range) [percentage of change in FEV1 after EVH]	-4	-9	-9	-5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Football Players, Basketball Players, Swimmers, Control Group
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0061
	Comments
	Method	Kruskal-Wallis
	Comments	post-hoc comparison with Dunn's multiple comparison test: p=0.0326 between arm 1 and 2; p=0.0147 between arm 1 and 3

2. Secondary Outcome

Title	Number of Participants With Allergies Determined by Positive Skin Prick Test
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Football Players	Basketball Players	Swimmers	Control Group
Arm/Group Description	Football players of the first grade of high school are recruited from the topsportschool in Leuven.	Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.	Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation	Age-matched controls are recruited (exercising at a recreational level, >4 hours).
Measure Participants	44	26	47	17
Number [participants]	14 31.8%	6 12.8%	19 73.1%	4 23.5%

3. Other Pre-specified Outcome

Title	Number of Sputum Uric Acid-high Subjects (Determined by ELISA on Sputum Supernatants)
Description	number of subjets with sputum uric acid level above p90 in controls
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

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/Group Title	Football Players	Basketball Players	Swimmers	Control Group
Arm/Group Description	Football players of the first grade of high school are recruited from the topsportschool in Leuven.	Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.	Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation	Age-matched controls are recruited (exercising at a recreational level, >4 hours).
Measure Participants	34	19	43	17
Number [participants]	15 34.1%	15 31.9%	26 100%	3 17.6%

Adverse Events

Arm/Group Title	Football Players		Swimmers		Basketball Players		Control Group
Arm/Group Description	Football players of the first grade of high school are recruited from the topsportschool in Leuven.		Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation		Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.		Age-matched controls are recruited (exercising at a recreational level, >4 hours).
All Cause Mortality
	Football Players		Swimmers		Basketball Players		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Football Players		Swimmers		Basketball Players		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/47 (0%)		0/26 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Football Players		Swimmers		Basketball Players		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/47 (0%)		0/26 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.