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Effect of Football on the Musculoskeletal System and Hormonal System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04839172
Recruitment Status : Completed
First Posted : April 9, 2021
Last Update Posted : March 9, 2022
Sponsor:
Collaborator:
Villarreal CF
Information provided by (Responsible Party):
Isabel Almodóvar Fernández, Cardenal Herrera University

Study Description
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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.

Condition or disease Intervention/treatment
Regional Body Composition Cortisol and Testosterone Levels Diagnostic Test: Dual-energy X-ray Absorptiometry (DXA) scan

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Study of the Effect of Football Practice on Bone Remodeling.
Actual Study Start Date : July 1, 2021
Actual Primary Completion Date : July 10, 2021
Actual Study Completion Date : December 30, 2021
Groups and Cohorts
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Intervention Details:
  • 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.
    Other Name: Fasting blood samples

Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 3 years ]
    to examine the evolution of total and regional body composition and cortisol and testosterone levels of Spanish elite soccer players during a soccer season


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Sampling Method:   Non-Probability Sample
Study Population
male professional soccer players playing in the top soccer championship in Spain
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04839172


Locations
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Spain
Villarreal CF
Villarreal, Castellón, Spain, 12540
Sponsors and Collaborators
Cardenal Herrera University
Villarreal CF
Investigators
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Study Chair: Adolfo Muñoz Macho, MD Medical Services of Villarreal CF SAD
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Isabel Almodóvar Fernández, PhD, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT04839172    
Other Study ID Numbers: CMOTC
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Isabel Almodóvar Fernández, Cardenal Herrera University:
Regional body composition
Testosterone
Cortisol