Exercise and Arterial Modulation in Youth

Completed

• Conditions: Childhood Obesity; Hypertension; Cardiovascular Disease; Endothelial Dysfunction

• Registration Number: NCT02853747
• Lead Sponsor: University of Basel

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-03
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin und Systemphysiologie; 🇨🇭 Basel, Basel Stadt, Switzerland