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AQUApay (AQUA Predictive Ability in Youths): Study on the Predictive Ability of the Questionnaire AQUA© in Children and Adolescents

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ClinicalTrials.gov Identifier: NCT03823586
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica

Brief Summary:
Allergic diseases like asthma, rhinitis, conjunctivitis and dermatitis are very frequent in athletes, even if those complaining allergic symptoms do not always receive a medical diagnosis. Many athletes already start competitive sport activities in pediatric age, but allergy screening tests are usually not performed when assessing eligibility to sport practice. Therefore, the primary objective of the present study is assessing the predictive ability of the Allergy Questionnaire for Athletes (AQUA©), pediatric version, to predict the atopic status in young athletes. The secondary objective is assessing the ability of AQUA© to predict an exercise-induced bronchoconstriction (EIB).

Condition or disease Intervention/treatment
Young Athletes Diagnostic Test: Questionnaire AQUA©, pediatric version

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Study Type : Observational
Estimated Enrollment : 152 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: AQUApay (AQUA Predictive Ability in Youths): Study on the Predictive Ability of the Questionnaire AQUA© in Children and Adolescents
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Group/Cohort Intervention/treatment
Children Diagnostic Test: Questionnaire AQUA©, pediatric version
A version of AQUA© recently adapted and pretested in young athletes. It is a self-administered questionnaire composed of 25 items includes items about type, duration and intensity of training sessions, allergic status, habits of children (supplements and drugs intake) and their parents (smoking), presence and burden of infections.

Adolescents Diagnostic Test: Questionnaire AQUA©, pediatric version
A version of AQUA© recently adapted and pretested in young athletes. It is a self-administered questionnaire composed of 25 items includes items about type, duration and intensity of training sessions, allergic status, habits of children (supplements and drugs intake) and their parents (smoking), presence and burden of infections.




Primary Outcome Measures :
  1. Atopic status [ Time Frame: Day 0 ]
    Having at least 1 positive skin prick test to common aero-allergens


Secondary Outcome Measures :
  1. Exercise-induced bronchoconstriction [ Time Frame: Day 0 ]
    Positivity to a bronchial provocation test, e.g. the "3-Min step-test".

  2. Psychological well-being [ Time Frame: Day 0 ]

    Percentage score from the WHO-5 questionnaire for measuring psychological well-being.

    The questionnaire is composed of 5 questions scored on a scale ranging from 0 (worse outcome) to 5 (best outcome). The total (raw) score is obtaining by summing all the individual score items, therefore it ranges from 0 (worse outcome) to 25 (best outcome). To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 represents worst possible outcome, whereas a score of 100 represents best possible outcome.


  3. Executive functioning (EF) [ Time Frame: Day 0 ]

    Total score from an experimental questionnaire (EF) for measuring difficulties in executive functioning.

    The questionnaire is composed of 20 questions scored on a scale ranging from 1 (worse outcome) to 4 (best outcome). The total score is obtaining by summing all the individual score items, therefore it ranges from 20 (worse outcome) to 100 (best outcome).




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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
76 athletes 7 to 10 years old, and 76 athletes aged 11 to 14 years old, recruited from several sport associations located in the city of Palermo (Italy).
Criteria

Inclusion Criteria:

- Athletes, males or females, 7 to 14 years old

Exclusion Criteria:

  • Respiratory infections in the previous 4 weeks;
  • Immunological or metabolic systemic diseases;
  • Major malformations of the upper airways;
  • Active smoker.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823586


Contacts
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Contact: Stefania La Grutta, PhD 0916809680 stefania.lagrutta@ibim.cnr.it

Locations
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Italy
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council Recruiting
Palermo, Sicily, Italy, 90146
Contact: Stefania La Grutta, PhD    +390916809680    stefania.lagrutta@ibim.cnr.it   
Sponsors and Collaborators
Istituto per la Ricerca e l'Innovazione Biomedica

Publications:
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Responsible Party: Stefania La Grutta, MD, Coordinator of the group "Clinical and Environmental Epidemiology of Pulmonary and Allergic Pediatric Diseases". Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy., Istituto per la Ricerca e l'Innovazione Biomedica
ClinicalTrials.gov Identifier: NCT03823586     History of Changes
Other Study ID Numbers: 01/2019
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No