NCT04839172

Brief Summary

Several studies have shown that football practice regulates bone remodeling, producing an increase of bone mineral density and reducing the risk of fractures. Thus, the aim of this study is to evaluate the effect of football practice on the regulation of bone turnover in Spanish adult football players. Thanks to the collaboration agreement "Aula Endavant" the Villarreal CF participates as a collaborator in this Project. This agreement allows us to use their facilities and to analyze several football players' data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

April 7, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

9 days

First QC Date

April 7, 2021

Last Update Submit

March 8, 2022

Conditions

Keywords

Regional body compositionTestosteroneCortisol

Outcome Measures

Primary Outcomes (1)

  • to examine the evolution of total and regional body composition and cortisol and testosterone levels of Spanish elite soccer players during a soccer season

    to examine the evolution of total and regional body composition and cortisol and testosterone levels of Spanish elite soccer players during a soccer season

    3 years

Interventions

Longitudinal changes in body composition are examined over four consecutive seasons (2017-2018, 2018-2019, 2019-2020, 2020-2021), four times per season in the following stages: start-preseason, start-season, mid-season and end-season.

Also known as: Fasting blood samples

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

male professional soccer players playing in the top soccer championship in Spain

You may qualify if:

  • male gender
  • aged between 18 and 40 years
  • who practice soccer for more than 6 hours / week from the age of 10 to the present.

You may not qualify if:

  • play other elite sports than soccer
  • play 6 or more hours of recreational sports per week
  • smokers
  • individuals with chronic cardiovascular diseases, hypo and hyperthyroidism, hypertension, rheumatoid arthritis and osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Villarreal CF

Villarreal, Castellón, 12540, Spain

Location

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Adolfo Muñoz Macho, MD

    Medical Services of Villarreal CF SAD

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 9, 2021

Study Start

July 1, 2021

Primary Completion

July 10, 2021

Study Completion

December 30, 2021

Last Updated

March 9, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations