Cardiovascular DiseaseExAMIN YOUTHNCT02853747
Exercise and Arterial Modulation in Youth
An observational study of Cardiovascular Disease and Childhood Obesity, run by University of Basel at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Childhood Obesity, Hypertension
- What is being tested?
- Physical Activity, 20-meter shuttle run
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 337 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- primary school children aged 6-8 years who can participate in physical education lessons with written consent from their parents.
Who cannot join
- children with a medical certificate that prohibits physical exercise with no consent from their parents.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin und Systemphysiologie
Basel, Canton of Basel-City, 4052
About this study
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.
Read the 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.
- Being tested
- Physical Activity, 20-meter shuttle run
- Keywords
- arterial stiffness, retinal vessels, physical activity, children
- Medical subject headings
- Cardiovascular Diseases, Pediatric Obesity, Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity, 20-meter shuttle runBehavioural
cross-sectional physical activity assessment and medical screeening
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of arterial stiffness (pulse wave velocity) with physical fitness in primary school children
Oscillometric calculation of central pulse wave velocity.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (3)
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).
Measured: Through study completion, an average of 1 year.
Association of subcutaneous advanced glycation endproducts (AGEs) with body composition, blood pressure and physical fitness
Non-invasive, subcutaneous measurement of AGEs (skin autofluorescence).
Measured: Through study completion, an average of one year.
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.
Measured: Through study completion, an average of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henner Hanssen, University of Basel
- Investigators
- Henner Hanssen, Prof. Dr. med., Principal investigator, University of BaselLukas Zahner, Prof. Dr., Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853747
- Sponsor's protocol ID
- EKNZ258/12
- Acronym
- ExAMIN YOUTH
- Status last verified
- Sep 2023
- First submitted
- 25 Jul 2016
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26105148Veijalainen 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.
PubMed 26220100Steinmann 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.
PubMed 25248341Hauser C, Lichtenstein E, Nebiker L, Streese L, Kochli S, Infanger D, Faude O, Hanssen H. Cardiorespiratory fitness and development of childhood cardiovascular risk: The EXAMIN YOUTH follow-up study. Front Physiol. 2023 Aug 23;14:1243434. doi: 10.3389/fphys.2023.1243434. eCollection 2023.
PubMed 37680774Kochli S, Smith W, Lona G, Goikoetxea-Sotelo G, Breet Y, Botha-Le Roux S, Mokwatsi GG, Kruger R, Hanssen H. Obesity, blood pressure and retinal microvascular phenotype in a bi-ethnic cohort of young children. Atherosclerosis. 2022 Jun;350:51-57. doi: 10.1016/j.atherosclerosis.2022.04.018. Epub 2022 Apr 21.
PubMed 35490596Kochli S, Deiseroth A, Hauser C, Streese L, Schmidt-Trucksass A, Faude O, Hanssen H. Body Composition and Physical Fitness Affect Central Hemodynamics in Young Children. Front Pediatr. 2021 Oct 27;9:750398. doi: 10.3389/fped.2021.750398. eCollection 2021.
PubMed 34778141Kochli S, Endes K, Grenacher J, Streese L, Lona G, Hauser C, Deiseroth A, Zahner L, Hanssen H. Socioeconomic Status and Parental Lifestyle Are Associated With Vascular Phenotype in Children. Front Public Health. 2021 Mar 26;9:610268. doi: 10.3389/fpubh.2021.610268. eCollection 2021.
PubMed 33842418Kochli S, Endes K, Bartenstein T, Usemann J, Schmidt-Trucksass A, Frey U, Zahner L, Hanssen H. Lung function, obesity and physical fitness in young children: The EXAMIN YOUTH study. Respir Med. 2019 Nov;159:105813. doi: 10.1016/j.rmed.2019.105813. Epub 2019 Nov 8.
PubMed 31731085Kochli S, Endes K, Steiner R, Engler L, Infanger D, Schmidt-Trucksass A, Zahner L, Hanssen H. Obesity, High Blood Pressure, and Physical Activity Determine Vascular Phenotype in Young Children. Hypertension. 2019 Jan;73(1):153-161. doi: 10.1161/HYPERTENSIONAHA.118.11872.
PubMed 30571553
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Arterial Modulation in Youth
- ClinicalTrials.gov ID
- NCT02853747
- Acronym / sponsor ID
- ExAMIN YOUTH / EKNZ258/12
- Keywords
- arterial stiffness, retinal vessels, physical activity, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- primary school children aged 6-8 years who can participate in physical education lessons with written consent from their parents.
Key exclusion criteria (1 listed)
- children with a medical certificate that prohibits physical exercise with no consent from their parents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity, 20-meter shuttle runcross-sectional physical activity assessment and medical screeening | Behavioural | – |
Primary outcome
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.
3 secondary outcomes
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.
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.
Association of lung function (FEV1/VC) with body composition, blood pressure and physical fitness
Time frame: Through study completion, an average of one year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Background: PubMed 26105148Imhof 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.
- Background: PubMed 26220100Veijalainen 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.
- Background: PubMed 25248341Steinmann 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.
- Derived from this study: PubMed 37680774Hauser C, Lichtenstein E, Nebiker L, Streese L, Kochli S, Infanger D, Faude O, Hanssen H. Cardiorespiratory fitness and development of childhood cardiovascular risk: The EXAMIN YOUTH follow-up study. Front Physiol. 2023 Aug 23;14:1243434. doi: 10.3389/fphys.2023.1243434. eCollection 2023.
- Derived from this study: PubMed 35490596Kochli S, Smith W, Lona G, Goikoetxea-Sotelo G, Breet Y, Botha-Le Roux S, Mokwatsi GG, Kruger R, Hanssen H. Obesity, blood pressure and retinal microvascular phenotype in a bi-ethnic cohort of young children. Atherosclerosis. 2022 Jun;350:51-57. doi: 10.1016/j.atherosclerosis.2022.04.018. Epub 2022 Apr 21.
- Derived from this study: PubMed 34778141Kochli S, Deiseroth A, Hauser C, Streese L, Schmidt-Trucksass A, Faude O, Hanssen H. Body Composition and Physical Fitness Affect Central Hemodynamics in Young Children. Front Pediatr. 2021 Oct 27;9:750398. doi: 10.3389/fped.2021.750398. eCollection 2021.
- Derived from this study: PubMed 33842418Kochli S, Endes K, Grenacher J, Streese L, Lona G, Hauser C, Deiseroth A, Zahner L, Hanssen H. Socioeconomic Status and Parental Lifestyle Are Associated With Vascular Phenotype in Children. Front Public Health. 2021 Mar 26;9:610268. doi: 10.3389/fpubh.2021.610268. eCollection 2021.
- Derived from this study: PubMed 31731085Kochli S, Endes K, Bartenstein T, Usemann J, Schmidt-Trucksass A, Frey U, Zahner L, Hanssen H. Lung function, obesity and physical fitness in young children: The EXAMIN YOUTH study. Respir Med. 2019 Nov;159:105813. doi: 10.1016/j.rmed.2019.105813. Epub 2019 Nov 8.
- Derived from this study: PubMed 30571553Kochli S, Endes K, Steiner R, Engler L, Infanger D, Schmidt-Trucksass A, Zahner L, Hanssen H. Obesity, High Blood Pressure, and Physical Activity Determine Vascular Phenotype in Young Children. Hypertension. 2019 Jan;73(1):153-161. doi: 10.1161/HYPERTENSIONAHA.118.11872.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henner Hanssen, Prof. Dr. med. principal investigator
University of Basel
Lukas Zahner, Prof. Dr. principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Childhood Obesity, run by University of Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of arterial stiffness (pulse wave velocity) with physical fitness in primary school children (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02853747, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023; AzTrials last refreshed its copy on 29 Oct 2026.