SoccerFUTBOMASNCT02399553
Effect of the Interaction Between the Type of Artificial Turf and Boots Model of Bone Health in Children Soccer Players
A study testing Soccer boot intervention in people with Soccer and Bone Density, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Soccer, Bone Density, Physical Fitness
- What is being tested?
- Soccer boot intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Taking medication affecting bone.
- Non-Caucasian.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Soccer, Bone Density, Physical Fitness
- Being tested
- Soccer boot intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soccer boot interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Soccer 2G | Experimental | Soccer players who trained in second generation artificial turf Receives: Other: Soccer boot intervention |
| Soccer 3G | Experimental | Soccer players who trained in third generation artificial turf Receives: Other: Soccer boot intervention |
| Soccer NG | Experimental | Soccer players who trained in natural grass Receives: Other: Soccer boot intervention |
| Soccer NON-NG | Experimental | Soccer players who trained in non-natural grass Receives: Other: Soccer boot intervention |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition during 2 years evaluated by Dual energy X-ray absorptiometry
Measured: Change from baseline in body composition at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startSep 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SoccerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José A. Casajús, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399553
- Sponsor's protocol ID
- DEP 2103-32724
- Acronym
- FUTBOMAS
- Status last verified
- May 2016
- First submitted
- 20 Mar 2015
- Last updated
- 12 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Interaction Between the Type of Artificial Turf and Boots Model of Bone Health in Children Soccer Players
- ClinicalTrials.gov ID
- NCT02399553
- Acronym / sponsor ID
- FUTBOMAS / DEP 2103-32724
- Conditions
- Soccer, Bone Density, Physical Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Soccer 2G | Experimental | Other: Soccer boot interventionSoccer players who trained in second generation artificial turf |
| Soccer 3G | Experimental | Other: Soccer boot interventionSoccer players who trained in third generation artificial turf |
| Soccer NG | Experimental | Other: Soccer boot interventionSoccer players who trained in natural grass |
| Soccer NON-NG | Experimental | Other: Soccer boot interventionSoccer players who trained in non-natural grass |
| Control group | No intervention | – |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Taking medication affecting bone.
- Non-Caucasian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soccer boot intervention | Other | Soccer 2G, Soccer 3G, Soccer NG, Soccer NON-NG |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soccer boot intervention in people with Soccer and Bone Density, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.