Trial Outcomes & Findings for Longitudinal Follow-up of High School Athletes (NCT NCT02432183)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

134 participants

Primary outcome timeframe

change from baseline compared to 15 minutes after EVH test

Results posted on

2024-01-10

Participant Flow

total number of control subjects is increased compared to protocol enrollment to compensate for gender imbalance

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.

Participant milestones

Participant milestones
Measure	Football Players Football 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	Basketball Players Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.	Control Group Age-matched controls are recruited (exercising at a recreational level, \>4 hours).
Overall Study STARTED	44	47	26	17
Overall Study COMPLETED	44	47	26	17
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Longitudinal Follow-up of High School Athletes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Football Players n=44 Participants Football players of the first grade of high school are recruited from the topsportschool in Leuven.	Swimmers n=47 Participants Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation	Basketball Players n=26 Participants Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.	Control Group n=17 Participants Age-matched controls are recruited (exercising at a recreational level, \>4 hours).	Total n=134 Participants Total of all reporting groups
Age, Categorical <=18 years	44 Participants n=5 Participants	47 Participants n=7 Participants	26 Participants n=5 Participants	17 Participants n=4 Participants	134 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	13.1 years STANDARD_DEVIATION 0.9 • n=5 Participants	12.1 years STANDARD_DEVIATION 0.8 • n=7 Participants	12.2 years STANDARD_DEVIATION 0.6 • n=5 Participants	12.9 years STANDARD_DEVIATION 1.8 • n=4 Participants	12.5 years STANDARD_DEVIATION 0.7 • n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	42 Participants n=21 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	36 Participants n=7 Participants	14 Participants n=5 Participants	5 Participants n=4 Participants	92 Participants n=21 Participants
Region of Enrollment Belgium	44 participants n=5 Participants	47 participants n=7 Participants	26 participants n=5 Participants	17 participants n=4 Participants	134 participants n=21 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Football Players n=39 Participants Football players of the first grade of high school are recruited from the topsportschool in Leuven.	Basketball Players n=22 Participants Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.	Swimmers n=45 Participants Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation	Control Group n=17 Participants Age-matched controls are recruited (exercising at a recreational level, \>4 hours).
Maximal Fall in Forced Expiratory Volume in One-second (FEV1) After Eucapnic Voluntary Hyperventilation (EVH) Test	-4 percentage of change in FEV1 after EVH Interval -11.0 to 3.0	-9 percentage of change in FEV1 after EVH Interval -18.0 to 0.0	-9 percentage of change in FEV1 after EVH Interval -15.0 to -2.0	-5 percentage of change in FEV1 after EVH Interval -11.0 to 1.0

SECONDARY outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Football Players n=44 Participants Football players of the first grade of high school are recruited from the topsportschool in Leuven.	Basketball Players n=26 Participants Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.	Swimmers n=47 Participants Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation	Control Group n=17 Participants Age-matched controls are recruited (exercising at a recreational level, \>4 hours).
Number of Participants With Allergies Determined by Positive Skin Prick Test	14 participants	6 participants	19 participants	4 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

number of subjets with sputum uric acid level above p90 in controls

Outcome measures

Outcome measures
Measure	Football Players n=34 Participants Football players of the first grade of high school are recruited from the topsportschool in Leuven.	Basketball Players n=19 Participants Basketball players of the first grade of high school are recruited from the topsportschool in Leuven.	Swimmers n=43 Participants Swimmers of the first grade of high school are recruited from the future team of the Flemish Swimming Federation	Control Group n=17 Participants Age-matched controls are recruited (exercising at a recreational level, \>4 hours).
Number of Sputum Uric Acid-high Subjects (Determined by ELISA on Sputum Supernatants)	15 participants	15 participants	26 participants	3 participants

Adverse Events

Football Players

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Swimmers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Basketball Players

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dominique MA Bullens

KU Leuven

Phone: 3216341338

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place