- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03085498
Sportcheck Follow-Up
October 10, 2018 updated by: Henner Hanssen, University of Basel
Sportcheck Follow-Up: Physical Fitness, Cardiovascular and Psychosocial Health in Primary School Childen
The study resembles a four-year follow-up on the influence of physical activity and fitness, blood pressure, BMI and stress on vascular health in primary schoolchildren.
It examines the predictive value of retinal vessel diameters for the development of childhood hypertension.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study aims to examine the usefulness of retinal vessel analysis in childhood cardiovascular prevention.
It investigates the long-term influence of physical activity and fitness on retinal vessel diameters, blood pressure, BMI and psychosocial stress in children.
The study aims to set new standards for an integrative primary prevention concept to initiate healthy ageing from childhood to adulthood.
Study Type
Observational
Enrollment (Actual)
280
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Basel Stadt
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Basel, Basel Stadt, Switzerland, 4052
- Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This study will be designed as a four-year follow-up of the 2014 Sportcheck.
All first-graders of primary schools in the canton Basel-Stadt took part in measurements of height, body weight and physical fitness during physical education lesson.
From the 1255 children, 540 (43%) were allowed by their parents to join additional measurements of blood pressure and retinal vessel diameters and filled in questionnaires.
In the year 2018, all fifth-graders of Basel-Stadt will be invited to take part in the same measurements as in 2014.
All children will again conduct physical fitness tests and measurements of height and body weight during physical education.
All children with an informed consent will participate in the same medical tests that were performed four years previously.
Description
Inclusion Criteria:
- All fifth-graders of public primary schools in Basel-Stadt with an informed consent signed by their parents are included.
Exclusion Criteria:
- Fifth-graders with motor-or other disabilities that do not allow participation will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retinal vessel diameter
Time Frame: Through study completion, an average of 1 year
|
To assess whether physical activity and fitness changes during the four-year follow-up influence retinal vessel diameters in children
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: Through study completion, an average of 1 year
|
To assess whether physical activity and fitness changes during the four-year follow-up influence blood pressure in children
|
Through study completion, an average of 1 year
|
|
Body mass index (BMI)
Time Frame: Through study completion, an average of 1 year
|
To assess whether physical activity and fitness changes during the four-year follow-up influence BMI in children
|
Through study completion, an average of 1 year
|
|
Psychosocial stress exposure as assessed by the conflict subscale of the Family Environment Scale
Time Frame: Through study completion, an average of 1 year
|
To assess whether physical activity and fitness changes during the four-year follow-up influence psychosocial stress in children
|
Through study completion, an average of 1 year
|
|
Health behavior as assessed by the HBSC Symptom Checklist
Time Frame: Through study completion, an average of 1 year
|
To assess whether health behavior has changed during the four-year follow-up
|
Through study completion, an average of 1 year
|
|
Health-related quality of life as assessed by the KINDL-R questionnaire
Time Frame: Through study completion, an average of 1 year
|
To assess whether physical activity and fitness changes during the four-year follow-up influence health-related quality of life
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Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lukas Zahner, Prof. Dr., University of Basel
- Principal Investigator: Henner Hanssen, Prof. Dr., University of Basel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lona G, Hauser C, Bade S, Kochli S, Infanger D, Endes K, Faude O, Hanssen H. Association of Parental Socioeconomic Status and Physical Activity with Development of Arterial Stiffness in Prepubertal Children. Int J Environ Res Public Health. 2021 Aug 3;18(15):8227. doi: 10.3390/ijerph18158227.
- Lona G, Hauser C, Kochli S, Infanger D, Endes K, Faude O, Hanssen H. Blood Pressure Increase and Microvascular Dysfunction Accelerate Arterial Stiffening in Children: Modulation by Physical Activity. Front Physiol. 2020 Dec 17;11:613003. doi: 10.3389/fphys.2020.613003. eCollection 2020.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2017
Primary Completion (Actual)
July 7, 2018
Study Completion (Actual)
October 1, 2018
Study Registration Dates
First Submitted
February 28, 2017
First Submitted That Met QC Criteria
March 14, 2017
First Posted (Actual)
March 21, 2017
Study Record Updates
Last Update Posted (Actual)
October 11, 2018
Last Update Submitted That Met QC Criteria
October 10, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKNZ_258/12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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