Clinical trial NCT02853747: Exercise and Arterial Modulation in Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Childhood Obesity
Hypertension
Endothelial Dysfunction
Keywords: arterial stiffness
retinal vessels
physical activity
children
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 337
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Association of arterial stiffness (pulse wave velocity) with physical fitness in primary school children
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Association of arteriolar-to-venular diameter ratio (AVR) with physical fitness in primary school children
timeFrame: Through study completion, an average of 1 year.
measure: Association of subcutaneous advanced glycation endproducts (AGEs) with body composition, blood pressure and physical fitness
timeFrame: Through study completion, an average of one year.
measure: Association of lung function (FEV1/VC) with body composition, blood pressure and physical fitness
timeFrame: Through study completion, an average of one year.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin und Systemphysiologie
state: Basel Stadt
Study officials:
affiliation: University of Basel
name: Henner Hanssen, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Basel
name: Lukas Zahner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.