- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01236222
Health Effects of Commuter Cycling
August 8, 2011 updated by: University of Southern Denmark
The purpose of this study is to determine whether cycling to school is effective in the prevention of the metabolic syndrome.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
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
-
-
-
Odense, Denmark, 5230
- University of Southern Denmark
-
-
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 13 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- passive commuted to school last 6 months, own a bike
Exclusion Criteria:
- less than 2 km to school
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: Cycling to school
|
Regular cycling to school
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fitness
Time Frame: Day 0, Day 120
|
Difference in VO2max determined by use of a metabolic cart
|
Day 0, Day 120
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metabolic syndrome
Time Frame: Day 0, Day 120
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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
March 1, 2011
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
November 4, 2010
First Submitted That Met QC Criteria
November 5, 2010
First Posted (Estimate)
November 7, 2010
Study Record Updates
Last Update Posted (Estimate)
August 9, 2011
Last Update Submitted That Met QC Criteria
August 8, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- Cycling
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.