CHAMPS Eye Study - Myopia and Retinal Vascular Geometry in Relation to Physical Activity

NCT02346006 | Completed DMC

• 1 other identifier: CES 001
• Study Type: interventional
• Target: 307
• Locations: 0 countries
• Sites: N/A

Brief Summary

An increasingly physical inactive lifestyle in the Western World has led to a higher number of lifestyle -related diseases. The consequences are now already present in childhood with an increased prevalence of overweight, obesity, and diabetes. Inactivity is also accompanied by cardiovascular iseases and is also thought to be associated with an increased incidence of nearsightedness (myopia). Myopia is the most frequent eye disease globally, and causes severe personal and societal expenses and may additionally lead to secondary eye disorders such as retinal detachment, glaucoma, and cataract. The retina is the only place in the human body where it is possible to directly inspect the blood vessels (microvasculature). Photography of the eye background allows a noninvasive examination of the retinal structure in which it is possible to make measurements on the retinal blood vessels. It is well known that early vascular chances can be detected with this method and that there are correlation between these changes and systemic diseases, such as hypertension, stroke and other cardiovascular diseases. This study is a new subproject in The Childhood Health, Activity, and Motor Performance School (CHAMPS) Study Denmark, also known as the Svendborg Project. The project has a well-defined cohort with originally 1515 school students who since 2007 have been divided into two groups: schools with extra exercise during school hours and matched traditional schools. CHAMPS-DK aims to investigate the effect of increased physical activity on current and future health of children and adolescents. Thanks to this unique child cohort it is possible to investigate the correlation between physical activity, myopia and retinal vascular diameters in a large group of Danish schoolchildren. We want to study the degree and reversibility of physical activity and its effect on the development of myopia and retinal blood vessel changes. However, there is still a lack of knowledge about the correlation between physical activity and retinal vascular diameters in children. Furthermore, it is still unclear whether physical activity can prevent the development of myopia; such a realization could have far-reaching consequences in form of a modified approach to the necessity for exercise and, furthermore, potentially a significant socio-economic benefit.

Conditions

Child; Motor Activity; Myopia

Keywords

Exercise; Visual Acuity; Blood Vessels; Retina; Choroid

Outcome Measures

Primary Outcomes (1)

• Myopic status in relation to physical activity (longitudinal data on physical activity)

  Myopic status in relation to longitudinal data on physical activity

  7 years

Secondary Outcomes (4)

• Retinal vessel geometry (caliber)

  None (analyzes on data from tests in march to july 2015, 4 months)

• Choroidal thickness

  None (analyzes on data from tests in march to july 2015, 4 months)

• Myopic status (data from tests in spring 2015)

  None (analyzes on data from tests in march to july 2015, 4 months)

• Myopia development

  10 years. Changes from baseline.

Study Arms (1)

Physical activity

EXPERIMENTAL

Subject from schools with more physical activity.

Behavioral: More physical activity.

Interventions

More physical activity. BEHAVIORAL

Subjects receiving more physical activity in school.

Physical activity

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children from the The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK) cohord.

You may not qualify if:

• None

Sponsors & Collaborators

• Odense University Hospital: lead

Related Publications (20)

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  PMID: 19618163 BACKGROUND

• Hanssen H, Siegrist M, Neidig M, Renner A, Birzele P, Siclovan A, Blume K, Lammel C, Haller B, Schmidt-Trucksass A, Halle M. Retinal vessel diameter, obesity and metabolic risk factors in school children (JuvenTUM 3). Atherosclerosis. 2012 Mar;221(1):242-8. doi: 10.1016/j.atherosclerosis.2011.12.029. Epub 2011 Dec 27.

  PMID: 22244041 BACKGROUND

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  PMID: 9614255 BACKGROUND

• Wedderkopp N, Jespersen E, Franz C, Klakk H, Heidemann M, Christiansen C, Moller NC, Leboeuf-Yde C. Study protocol. The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK). BMC Pediatr. 2012 Aug 20;12:128. doi: 10.1186/1471-2431-12-128.

  PMID: 22906115 BACKGROUND

• Heidemann M, Molgaard C, Husby S, Schou AJ, Klakk H, Moller NC, Holst R, Wedderkopp N. The intensity of physical activity influences bone mineral accrual in childhood: the childhood health, activity and motor performance school (the CHAMPS) study, Denmark. BMC Pediatr. 2013 Mar 2;13:32. doi: 10.1186/1471-2431-13-32.

  PMID: 23452342 BACKGROUND

• Lundberg K, Kawasaki R, Sjolie AK, Wong TY, Grauslund J. Localized changes in retinal vessel caliber after focal/grid laser treatment in patients with diabetic macular edema: a measure of treatment response? Retina. 2013 Nov-Dec;33(10):2089-95. doi: 10.1097/IAE.0b013e3182891dda.

  PMID: 23514802 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Myopia

Condition Hierarchy (Ancestors)

Behavior; Refractive Errors; Eye Diseases

Study Officials

• Kristian Lundberg, MD

  Department of Ophthalmology, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 26, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-04