Exercise and Arterial Modulation in Youth (ExAMIN YOUTH)

September 21, 2023 updated by: Henner Hanssen, University of Basel
The project is designed as a large scale, cross-sectional study. The aim of the study is to investigate the association of micro- and macrovascular function with physical fitness and body composition in primary school children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will examine whether physical fitness, body composition and blood pressure differently affect large and small arteries in young children. Furthermore, the investigators will examine whether pulmonary dysfunction is associated with vascular disorders and if subcutaneous advanced glycation endproducts (AGE's) mediate some of the vascular alterations observed.

Study Type

Observational

Enrollment (Actual)

337

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel Stadt
      • Basel, Basel Stadt, Switzerland, 4052
        • Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin und Systemphysiologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

ExAMIN YOUTH is a cooperative project between the department of sport, movement and health sciences (DSBG) of the University of Basel and the Cantonal Office of Sport of Basel-Stadt (COS-BS). Primary school children aged 6 to 8 years of the City of Basel are examined.The investigators expect to include n=1200 children in this cross-sectional study.

Description

Inclusion Criteria:

  • primary school children aged 6-8 years who can participate in physical education lessons with written consent from their parents.

Exclusion Criteria:

  • children with a medical certificate that prohibits physical exercise with no consent from their parents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of arterial stiffness (pulse wave velocity) with physical fitness in primary school children
Time Frame: Through study completion, an average of 1 year.
Oscillometric calculation of central pulse wave velocity.
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of arteriolar-to-venular diameter ratio (AVR) with physical fitness in primary school children
Time Frame: Through study completion, an average of 1 year.
Retinal vessel diameters by use of Static Retinal Vessel Analyzer (SVA-T).
Through study completion, an average of 1 year.
Association of subcutaneous advanced glycation endproducts (AGEs) with body composition, blood pressure and physical fitness
Time Frame: Through study completion, an average of one year.
Non-invasive, subcutaneous measurement of AGEs (skin autofluorescence).
Through study completion, an average of one year.
Association of lung function (FEV1/VC) with body composition, blood pressure and physical fitness
Time Frame: Through study completion, an average of one year.
Handheld spirometer (EasyOne Diagnostic) to measure vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV1) and the ratio of FEV1/VC.
Through study completion, an average of one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Basel

Investigators

  • Principal Investigator: Henner Hanssen, Prof. Dr. med., University of Basel
  • Principal Investigator: Lukas Zahner, Prof. Dr., University of Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimated)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKNZ258/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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