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

Young Athletes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823586
• Other study ID #: 01/2019
• Status: Completed
• Start date: March 11, 2019
• Est. completion date: February 7, 2020

Study information

• Verified date: August 2020
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: February 7, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Young Athletes

Intervention

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.

Locations

Country	Name	City	State
Italy	Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council	Palermo	Sicily

Sponsors (1)

Lead Sponsor	Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atopic status	Having at least 1 positive skin prick test to common aero-allergens	Day 0
Secondary	Psychological well-being	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.	Day 0