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

Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica (Other)
Overall Status
Completed
CT.gov ID
NCT03823586
Collaborator
(none)
133
1
10.9
12.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Questionnaire AQUA©, pediatric version

Study Design

Study Type:
Observational
Actual Enrollment :
133 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 :
Mar 11, 2019
Actual Primary Completion Date :
Feb 7, 2020
Actual Study Completion Date :
Feb 7, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Atopic status [Day 0]

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

Secondary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council Palermo Sicily Italy 90146

Sponsors and Collaborators

  • Istituto per la Ricerca e l'Innovazione Biomedica

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
Other Study ID Numbers:
  • 01/2019
First Posted:
Jan 30, 2019
Last Update Posted:
Sep 1, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 1, 2020