- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02399553
Effect of the Interaction Between the Type of Artificial Turf and Boots Model of Bone Health in Children Soccer Players (FUTBOMAS)
The number of turf fields has experienced an important increase in public and private facilities during the last years. This artificial surface will be predominant in any soccer field in the next years. Among turf fields there are many different types depending on their construction characteristics (with and without asphalted base, elastic base, rubber filling, etc.). Officially all types of artificial turfs should have similar stability and impact absorption characteristics. On the other hand there is a great variety of soccer-boots, especially for youth soccer players, similar to the football stars.
Many evidences support the fact that when a person exercises many different type of impacts-stimulus are necessary in order to stimulate bone and skeletal muscle systems. However, it is not known yet whether this effect can be extended or shortened depending on the type of artificial surface and soccer-boots used, or even more whether it could be more or less dangerous and/or provoke injuries/disagreement among the users. Little information is available in youth soccer player pointing in the same direction but still controversial. Furthermore, bone strength do not only depends on bone mass but on bone structure and microarchitecture. The cross sectional area, cortex thickness or trabecular density are important aspects of bone health. There are few studies on the effect of interaction between turf field and soccer boots on bone architecture of youth soccer players. This information is relevant for present and future health of adolescents practicing football and for all the organizations promoting this sport.
Due to the fact that turf fields are preferentially used by youth populations, it is important to know the real effects of the interaction between of different type of artificial surfaces and soccer boots on children bone mass development. Nowadays, there are no data and/or defined guidelines that can answer those unresolved questions, thus the main aim of the present project is to identify which turf field and soccer boots are the most adequate to optimize the acquisitions of bone mass in children soccer players.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zaragoza, Spain, 50009
- José Antonio Casajús Mallén
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Both: Aged from 11-13 years.
- Both: Parental/guardian permission (informed consent) and if appropriate, child verbal assent.
- Specific for the control group: Subjects that do not perform more than 3 hours of physical activity per week.
Exclusion Criteria:
- Taking medication affecting bone.
- Non-Caucasian.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
|
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Experimental: Soccer 2G
Soccer players who trained in second generation artificial turf
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Experimental: Soccer 3G
Soccer players who trained in third generation artificial turf
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Experimental: Soccer NG
Soccer players who trained in natural grass
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Experimental: Soccer NON-NG
Soccer players who trained in non-natural grass
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in body composition during 2 years evaluated by Dual energy X-ray absorptiometry
Time Frame: Change from baseline in body composition at 2 years
|
Change from baseline in body composition at 2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DEP 2103-32724
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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