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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01236222
Other study ID # Cycling
Secondary ID
Status Completed
Phase N/A
First received November 4, 2010
Last updated August 8, 2011
Start date March 2011
Est. completion date June 2011

Study information

Verified date August 2011
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether cycling to school is effective in the prevention of the metabolic syndrome.


Description:

Physical activity plays a crucial role in relation to prevent a clustering of risk factors. In adults a lower all-cause mortality has been found in those cycling to work compared to inactive commuters. It thus seems possible that cycling to school will entail health beneficial effects for children.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 10 Years to 13 Years
Eligibility Inclusion Criteria:

- passive commuted to school last 6 months, own a bike

Exclusion Criteria:

- less than 2 km to school

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Cycling to school
Regular cycling to school

Locations

Country Name City State
Denmark University of Southern Denmark Odense

Sponsors (2)

Lead Sponsor Collaborator
University of Southern Denmark TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fitness Difference in VO2max determined by use of a metabolic cart Day 0, Day 120 No
Secondary Metabolic syndrome Metabolic syndrome as defined by the international diabetes federation based upon: obesity(from age and gender adjusted BMI),TG,HDL,blood pressure,glucose (fasting) Day 0, Day 120 No
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