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Completed

NCT Number: NCT02853747

Exercise and Arterial Modulation in Youth

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.

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Key information

Conditions

Cardiovascular Disease Behavior Body Weight Cardiovascular Diseases Childhood Obesity Endothelial Dysfunction Hypertension Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Vascular Diseases

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin und Systemphysiologie

Basel, Canton of Basel-City, 4052, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Activity, 20-meter shuttle run

Behavioral

cross-sectional physical activity assessment and medical screeening

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Basel

Other

Registry information

Acronym: ExAMIN YOUTH

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2016
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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