Young AthletesNCT03823586
AQUApay (AQUA Predictive Ability in Youths): Study on the Predictive Ability of the Questionnaire AQUA© in Children and Adolescents
An observational study of Young Athletes, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Young Athletes
- What is being tested?
- Questionnaire AQUA©, pediatric version
- How many people
- 133 participants
- Where
- 1 siteItaly
- Study dates
- 11 Mar 2019to 7 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Athletes aged 7 to 14 years old, recruited from several sport associations located in the city of Palermo (Italy).
Who may be able to join
- Athletes, males or females, 7 to 14 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, 90146
About this study
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.
- Conditions
- Young Athletes
- Being tested
- Questionnaire AQUA©, pediatric version
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AQUA©, pediatric versionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Children | Not described Receives: Diagnostic Test: Questionnaire AQUA©, pediatric version | |
| Adolescents | Not described Receives: Diagnostic Test: Questionnaire AQUA©, pediatric version |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atopic status
Having at least 1 positive skin prick test to common aero-allergens
Measured: Day 0
Secondary outcomes (1)
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start11 Mar 2019
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Young AthletesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823586
- Sponsor's protocol ID
- 01/2019
- Status last verified
- Aug 2020
- First submitted
- 29 Jan 2019
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fasola S, Ferrante G, Malizia V, Bommarito N, Del Giacco S, Bonini M, Baiardini I, Bellafiore M, La Grutta S. Validity and repeatability of the Pediatric Allergy Questionnaire for Athletes (AQUAped) for the screening of atopy. Pediatr Allergy Immunol. 2021 Apr;32(3):437-444. doi: 10.1111/pai.13410. Epub 2020 Dec 2.
PubMed 33202069
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AQUApay (AQUA Predictive Ability in Youths): Study on the Predictive Ability of the Questionnaire AQUA© in Children and Adolescents
- ClinicalTrials.gov ID
- NCT03823586
- Acronym / sponsor ID
- 01/2019
- Conditions
- Young Athletes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | Diagnostic Test: Questionnaire AQUA©, pediatric version |
| Adolescents | – | Diagnostic Test: Questionnaire AQUA©, pediatric version |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Athletes aged 7 to 14 years old, recruited from several sport associations located in the city of Palermo (Italy).
Key inclusion criteria (1 listed)
- Athletes, males or females, 7 to 14 years old
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire AQUA©, pediatric versionA 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. | Diagnostic test | Adolescents, Children |
Primary outcome
Atopic status
Time frame: Day 0
Having at least 1 positive skin prick test to common aero-allergens
1 secondary outcome
Psychological well-being
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Derived from this study: PubMed 33202069Fasola S, Ferrante G, Malizia V, Bommarito N, Del Giacco S, Bonini M, Baiardini I, Bellafiore M, La Grutta S. Validity and repeatability of the Pediatric Allergy Questionnaire for Athletes (AQUAped) for the screening of atopy. Pediatr Allergy Immunol. 2021 Apr;32(3):437-444. doi: 10.1111/pai.13410. Epub 2020 Dec 2.
- Individual participant dataSharing planned: No
Related trials for Young Athletes
Not yet recruiting
Effects of Manual Lymphatic Drainage and Pressotherapy on Muscle Recovery After Eccentric Exercise in Physically Active Young Adults
Young Athletes
Active, not recruiting
SUSTAINA Study: Effects of Sustainable Diet and Therapeutic Exercise on Health in Young Athletes
Metabolic Health, Musculoskeletal Disorders (MSDs)
Recruiting
Effects of a Multimodal and Multidimensional Intervention on Urinary Incontinence in Young Nulliparous Female Athletes.
Urinary Incontinence
Recruiting
Young Athlete Body Project - Prevention of Body Dissatisfaction and Eating Disorders Among Adolescent Athletes
Eating Disorders in Adolescence, Body Dissatisfaction
RecruitingObservational study
Sudden Cardiac Arrest Related to Sport in Young and Value of the Genetic Assessment: a French Prospective Register
Sudden Cardiac Arrest, Sudden Cardiac Death
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Young Athletes, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atopic status (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03823586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.