NCT02853747

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
337

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

July 25, 2016

Last Update Submit

September 21, 2023

Conditions

Keywords

arterial stiffnessretinal vesselsphysical activitychildren

Outcome Measures

Primary Outcomes (1)

  • Association of arterial stiffness (pulse wave velocity) with physical fitness in primary school children

    Oscillometric calculation of central pulse wave velocity.

    Through study completion, an average of 1 year.

Secondary Outcomes (3)

  • Association of arteriolar-to-venular diameter ratio (AVR) with physical fitness in primary school children

    Through study completion, an average of 1 year.

  • Association of subcutaneous advanced glycation endproducts (AGEs) with body composition, blood pressure and physical fitness

    Through study completion, an average of one year.

  • Association of lung function (FEV1/VC) with body composition, blood pressure and physical fitness

    Through study completion, an average of one year.

Interventions

cross-sectional physical activity assessment and medical screeening

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin und Systemphysiologie

Basel, Canton of Basel-City, 4052, Switzerland

Location

Related Publications (9)

  • Imhof K, Zahner L, Schmidt-Trucksass A, Faude O, Hanssen H. Influence of physical fitness and activity behavior on retinal vessel diameters in primary schoolchildren. Scand J Med Sci Sports. 2016 Jul;26(7):731-8. doi: 10.1111/sms.12499. Epub 2015 Jun 24.

    PMID: 26105148BACKGROUND
  • Veijalainen A, Tompuri T, Haapala EA, Viitasalo A, Lintu N, Vaisto J, Laitinen T, Lindi V, Lakka TA. Associations of cardiorespiratory fitness, physical activity, and adiposity with arterial stiffness in children. Scand J Med Sci Sports. 2016 Aug;26(8):943-50. doi: 10.1111/sms.12523. Epub 2015 Jul 29.

    PMID: 26220100BACKGROUND
  • Steinmann M, Abbas C, Singer F, Casaulta C, Regamey N, Haffner D, Fischer DC, Simonetti GD. Arterial stiffness is increased in asthmatic children. Eur J Pediatr. 2015 Apr;174(4):519-23. doi: 10.1007/s00431-014-2423-2. Epub 2014 Sep 25.

    PMID: 25248341BACKGROUND
  • Hauser C, Lichtenstein E, Nebiker L, Streese L, Kochli S, Infanger D, Faude O, Hanssen H. Cardiorespiratory fitness and development of childhood cardiovascular risk: The EXAMIN YOUTH follow-up study. Front Physiol. 2023 Aug 23;14:1243434. doi: 10.3389/fphys.2023.1243434. eCollection 2023.

  • Kochli S, Smith W, Lona G, Goikoetxea-Sotelo G, Breet Y, Botha-Le Roux S, Mokwatsi GG, Kruger R, Hanssen H. Obesity, blood pressure and retinal microvascular phenotype in a bi-ethnic cohort of young children. Atherosclerosis. 2022 Jun;350:51-57. doi: 10.1016/j.atherosclerosis.2022.04.018. Epub 2022 Apr 21.

  • Kochli S, Deiseroth A, Hauser C, Streese L, Schmidt-Trucksass A, Faude O, Hanssen H. Body Composition and Physical Fitness Affect Central Hemodynamics in Young Children. Front Pediatr. 2021 Oct 27;9:750398. doi: 10.3389/fped.2021.750398. eCollection 2021.

  • Kochli S, Endes K, Grenacher J, Streese L, Lona G, Hauser C, Deiseroth A, Zahner L, Hanssen H. Socioeconomic Status and Parental Lifestyle Are Associated With Vascular Phenotype in Children. Front Public Health. 2021 Mar 26;9:610268. doi: 10.3389/fpubh.2021.610268. eCollection 2021.

  • Kochli S, Endes K, Bartenstein T, Usemann J, Schmidt-Trucksass A, Frey U, Zahner L, Hanssen H. Lung function, obesity and physical fitness in young children: The EXAMIN YOUTH study. Respir Med. 2019 Nov;159:105813. doi: 10.1016/j.rmed.2019.105813. Epub 2019 Nov 8.

  • Kochli S, Endes K, Steiner R, Engler L, Infanger D, Schmidt-Trucksass A, Zahner L, Hanssen H. Obesity, High Blood Pressure, and Physical Activity Determine Vascular Phenotype in Young Children. Hypertension. 2019 Jan;73(1):153-161. doi: 10.1161/HYPERTENSIONAHA.118.11872.

MeSH Terms

Conditions

Cardiovascular DiseasesPediatric ObesityHypertensionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Henner Hanssen, Prof. Dr. med.

    University of Basel

    PRINCIPAL INVESTIGATOR
  • Lukas Zahner, Prof. Dr.

    University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.med. Henner Hanssen

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 3, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

September 25, 2023

Record last verified: 2023-09

Locations