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

Completed

• Conditions: Young Athletes
• Interventions: Diagnostic Test: Questionnaire AQUA©, pediatric version

• Registration Number: NCT03823586
• Lead Sponsor: 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-30
• Study Start: 2019-03-11
• Primary Completion: 2020-02-07
• Study Completion: 2020-02-07
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

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

Exclusion Criteria

• Use of systemic antihistamines or long term or high dose corticosteroids in the last two weeks;
• Poor understanding of written or spoken Italian;
• Lack of written informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adolescents	Questionnaire AQUA©, pediatric version	-
Children	Questionnaire AQUA©, pediatric version	-

Primary Outcome Measures

Name	Time	Method
Atopic status	Day 0	Having at least 1 positive skin prick test to common aero-allergens

Secondary Outcome Measures

Name	Time	Method
Psychological well-being	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.

Trial Locations

Locations (1)

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council; 🇮🇹 Palermo, Sicily, Italy