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Completed

NCT Number: NCT03823586

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

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.

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Key information

Conditions

Young Athletes

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Palermo, Sicily, 90146, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire AQUA©, pediatric version

Diagnostic Test

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 outcomes

  1. Atopic status

    Time frame: Day 0

    Having at least 1 positive skin prick test to common aero-allergens

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2019
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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