NCT02399553

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

March 20, 2015

Last Update Submit

May 11, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in body composition during 2 years evaluated by Dual energy X-ray absorptiometry

    Change from baseline in body composition at 2 years

Study Arms (5)

Soccer 2G

EXPERIMENTAL

Soccer players who trained in second generation artificial turf

Other: Soccer boot intervention

Soccer 3G

EXPERIMENTAL

Soccer players who trained in third generation artificial turf

Other: Soccer boot intervention

Soccer NG

EXPERIMENTAL

Soccer players who trained in natural grass

Other: Soccer boot intervention

Soccer NON-NG

EXPERIMENTAL

Soccer players who trained in non-natural grass

Other: Soccer boot intervention

Control group

NO INTERVENTION

Interventions

Soccer 2GSoccer 3GSoccer NGSoccer NON-NG

Eligibility Criteria

Age11 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Taking medication affecting bone.
  • Non-Caucasian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

José Antonio Casajús Mallén

Zaragoza, Zaragoza, 50009, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffesor

Study Record Dates

First Submitted

March 20, 2015

First Posted

March 26, 2015

Study Start

September 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations