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Exercise and Arterial Modulation in Youth (ExAMIN YOUTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853747
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Henner Hanssen, 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.

Condition or disease Intervention/treatment
Cardiovascular Disease Childhood Obesity Hypertension Endothelial Dysfunction Behavioral: high-intensity-interval-training

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.

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Study Type : Observational
Actual Enrollment : 337 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Actual Study Start Date : May 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: high-intensity-interval-training
    12 weeks of walking-based HIIT training


Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853747


Locations
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Switzerland
Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin und Systemphysiologie
Basel, Basel Stadt, Switzerland, 4052
Sponsors and Collaborators
University of Basel
Investigators
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Principal Investigator: Henner Hanssen, Prof. Dr. med. University of Basel
Principal Investigator: Lukas Zahner, Prof. Dr. University of Basel
Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Homepage DSBG Research

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Henner Hanssen, Prof.Dr.med. Henner Hanssen, University of Basel
ClinicalTrials.gov Identifier: NCT02853747    
Other Study ID Numbers: EKNZ258/12
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Keywords provided by Henner Hanssen, University of Basel:
arterial stiffness
retinal vessels
physical activity
children
Additional relevant MeSH terms:
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Cardiovascular Diseases
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight