- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01942096
Study of Airway Inflammation in Relation to Exercise in Elite Athletes
Study Overview
Status
Conditions
Detailed Description
Competitive swimmers, competitive indoor athletes and control individuals performing sports at a recreational level will be recruited for the study.
They will perform a sport-specific training (swimmers and controls: swimming for 90 minutes, indoor athletes: basketball or volleyball for 90 minutes)
Baseline measurements:
- Airway inflammation upper and lower airways will be assessed by collection of nasal fluid (nasal sponge will be inserted in nostril for 5 minutes), Fraction of exhaled Nitric Oxide measurement and sputum induction.
- Upper and lower airway symptoms will be assessed by questionnaires (SinoNasal Outcome Measure-22, Visual Analogue Score, Asthma Symptom Score and Juniper Score)
- Allergy will be assessed by skin prick test (on skin) and immunocap test (in blood, 1 tube of 10 ml).
- Lung function and nasal patency will be measured by spirometry and Peak Nasal Inspiratory Flow measurement.
- Exercise induced bronchoconstriction will be assessed by eucapnic voluntary hyperventilation test.
Measurements immediately after training:
- Collection of nasal fluid
- Assessment of upper airway symptoms (Visual Analogue Score)
- Spirometry and Fraction of Exhaled Nitric Oxide measurement
- Peak Nasal Inspiratory Flow measurement
Measurements 24 hours after training:
- Collection of nasal fluid
- Assessment of upper airway symptoms (Visual Analogue Score)
- Spirometry and Fraction of Exhaled Nitric Oxide measurement
- Peak Nasal Inspiratory Flow measurement
- Sputum induction
- Venous puncture (1 tube of 10 ml)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- UZ Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Performing sports at national or international level (swimmers and indoor athletes)
Exclusion Criteria:
- Performing sport at recreational level (not more than 4 hours/week for healthy individuals)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Competitive swimmers
Swimmers performing at national or international level
|
|
Competitive indoor athletes
Indoor athletes performing at national or international level
|
|
Healthy control individuals
Individuals performing sports at a recreational level
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of airway inflammation
Time Frame: Baseline, immediately after and 24 hours after sport-specific training
|
Airway inflammation upper and lower airways will be assessed by collection of nasal fluid (nasal sponge will be inserted in nostril for 5 minutes), Fraction of exhaled Nitric Oxide measurement and sputum induction.
|
Baseline, immediately after and 24 hours after sport-specific training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of exercise induced bronchoconstriction
Time Frame: baseline
|
Exercise induced bronchoconstriction will be assessed by eucapnic voluntary hyperventilation test.
|
baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of allergy
Time Frame: baseline
|
-Allergy will be assessed by skin prick test (on skin) and immunocap test (in blood, 1 tube of 10 ml).
|
baseline
|
|
Assessment of upper and lower airway symptoms
Time Frame: Baseline, immediately after and 24 hours after sport-specific training
|
-Upper and lower airway symptoms will be assessed by questionnaires (SinoNasal Outcome Measure-22, Visual Analogue Score, Asthma Symptom Score and Juniper Score)
|
Baseline, immediately after and 24 hours after sport-specific training
|
|
Measurement of lung function and nasal patency
Time Frame: at baseline, immediately after and 24 hours sport-specific training
|
-Lung function and nasal patency will be measured by spirometry and Peak Nasal Inspiratory Flow measurement.
|
at baseline, immediately after and 24 hours sport-specific training
|
Collaborators and Investigators
Investigators
- Study Director: Sven F Seys, MSc, lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven
- Study Director: Valerie Hox, MD, lab of clinical immunology, CDG 8th floor, Herestraat 49, 3000 Leuven
Publications and helpful links
General Publications
- Seys SF, Hox V, Van Gerven L, Dilissen E, Marijsse G, Peeters E, Dekimpe E, Kasran A, Aertgeerts S, Troosters T, Vanbelle V, Peers K, Ceuppens JL, Hellings PW, Dupont LJ, Bullens DM. Damage-associated molecular pattern and innate cytokine release in the airways of competitive swimmers. Allergy. 2015 Feb;70(2):187-94. doi: 10.1111/all.12540.
- Steelant B, Hox V, Van Gerven L, Dilissen E, Dekimpe E, Kasran A, Aertgeerts S, Van Belle V, Peers K, Dupont LJ, Hellings PW, Bullens DM, Seys SF. Nasal symptoms, epithelial injury and neurogenic inflammation in elite swimmers. Rhinology. 2018 Sep 1;56(3):279-287. doi: 10.4193/Rhin17.167.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML7650
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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