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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

Tracking Information
First Submitted Date July 25, 2016
First Posted Date August 3, 2016
Last Update Posted Date October 15, 2018
Actual Study Start Date May 2016
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 29, 2016)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 29, 2016)
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exercise and Arterial Modulation in Youth
Official Title Not Provided
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Cardiovascular Disease
  • Childhood Obesity
  • Hypertension
  • Endothelial Dysfunction
Intervention Behavioral: high-intensity-interval-training
12 weeks of walking-based HIIT training
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 10, 2018)
337
Original Estimated Enrollment
 (submitted: July 29, 2016)
1200
Actual Study Completion Date May 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 8 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02853747
Other Study ID Numbers EKNZ258/12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Henner Hanssen, University of Basel
Study Sponsor University of Basel
Collaborators Not Provided
Investigators
Principal Investigator: Henner Hanssen, Prof. Dr. med. University of Basel
Principal Investigator: Lukas Zahner, Prof. Dr. University of Basel
PRS Account University of Basel
Verification Date October 2018