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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04839172
Other study ID # CMOTC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date December 30, 2021

Study information

Verified date March 2022
Source Cardenal Herrera University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Several studies have shown that football practice regulates bone remodeling, producing an increase of bone mineral density and reducing the risk of fractures. These studies are mainly performed in adolescents and there are few results obtained from European adults subjects. 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. Secondary objectives include: describing bone mineral density values, evaluating percentage of total lean mass and body fat, describing dietary and physical habits and analyzing blood tests of professional football players. As well as, they include updating the current state of knowledge of the influence of sports on bone. 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. In addition, different members of the club will directly participate as researchers during the development of this study. One of the strengths of this study is that the data were obtained from two consecutive seasons of an elite soccer team. One of the potential limitations that we have faced in this study is that in order to obtain a large sample, it is necessary to analyse the soccers from two consecutive seasons, which makes the study temporarily longer than desired.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 30, 2021
Est. primary completion date July 10, 2021
Accepts healthy volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Intervention

Diagnostic Test:
Dual-energy X-ray Absorptiometry (DXA) scan
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.

Locations

Country Name City State
Spain Villarreal CF Villarreal Castellón

Sponsors (2)

Lead Sponsor Collaborator
Cardenal Herrera University Villarreal CF

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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