Exercise and Arterial Modulation in Youth

Hypertension Clinical Trial

— ExAMIN YOUTH  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853747
• Other study ID #: EKNZ258/12
• Status: Completed
• Start date: May 2016
• Est. completion date: May 2018

Study information

• Verified date: September 2023
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Childhood Obesity
• Endothelial Dysfunction
• Hypertension
• Pediatric Obesity

Intervention

Behavioral:
• Physical Activity, 20-meter shuttle run
cross-sectional physical activity assessment and medical screeening

Locations

Country	Name	City	State
Switzerland	Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin und Systemphysiologie	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University of Basel

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Association of arteriolar-to-venular diameter ratio (AVR) with physical fitness in primary school children	Retinal vessel diameters by use of Static Retinal Vessel Analyzer (SVA-T).	Through study completion, an average of 1 year.
Secondary	Association of subcutaneous advanced glycation endproducts (AGEs) with body composition, blood pressure and physical fitness	Non-invasive, subcutaneous measurement of AGEs (skin autofluorescence).	Through study completion, an average of one year.
Secondary	Association of lung function (FEV1/VC) with body composition, blood pressure and physical fitness	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.