NCT03017976

Brief Summary

This study aims to assess the influence of exposure to swimming pool environment on respiratory symptoms and diseases, and on cancer outcomes among swimmers and swimming pool attendants.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 11, 2017

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

December 22, 2016

Last Update Submit

January 9, 2017

Conditions

Outcome Measures

Primary Outcomes (5)

  • Spirometry with bronchodilation

    First week after recruitment

  • Airway resistance measurement

    First week after recruitment

  • Airway reactance measurement

    First week after recruitment

  • Fractional concentration of orally exhaled nitric oxide

    First week after recruitment

  • Volatile organic compounds in the exhaled breath condensate

    First week after recruitment

Secondary Outcomes (3)

  • Diagnosis of immunoglobulin E (IgE) mediated allergies by skin prick testing

    First week after recruitment

  • Autonomic nervous system function assessment by pupillometry

    First week after recruitment

  • Transepidermal water loss

    First week after recruitment

Study Arms (2)

Competitive swimmers

Regular and naïf competitive swimmers will be followed for a mean period of 90 days. A battery of measurements and biological samples will be collected at the baseline evaluation and 90 days after, in order to evaluate long-term changes in respiratory health biomarkers. Measurements will also be performed before and after a single regular training session in order to assess acute effects in respiratory health biomarkers.

Recreational swimmers and swimming pool staff

Swimming pool physicochemical and microbiological characteristics and the association between each parameter measured as an indicator of water and air quality, contamination of surfaces will be evaluated and the association with recreational users, swimming teachers and pool attendants health parameters will be studied.

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Competitive swimmers, recreational users and swimming pool workers attending chlorinated and brominated public indoor municipal swimming pools in the North of Portugal.

Competitive swimmers, recreational swimmers or pool workers of a participating indoor swimming pool; Individuals with 12 years of age or older; Individuals who provide (or their caregivers) a signed informed consent.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine of Porto University

Porto, Porto District, 4200-319, Portugal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Exhaled breath condensate (no DNA) Blood (DNA) Urine (DNA)

MeSH Terms

Conditions

AsthmaLung Diseases

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2016

First Posted

January 11, 2017

Study Start

January 1, 2017

Primary Completion

March 1, 2017

Study Completion

July 1, 2018

Last Updated

January 11, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations