Regional Body CompositionNCT04839172
Effect of Football on the Musculoskeletal System and Hormonal System
An observational study of Regional Body Composition and Cortisol and Testosterone Levels, run by Cardenal Herrera University at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Regional Body Composition, Cortisol and Testosterone Levels
- What is being tested?
- Dual-energy X-ray Absorptiometry (DXA) scan
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2021to 30 Dec 2021
- Phase
- Observational
- 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 18 to 40 years
- Men only
- Adult
Study population: male professional soccer players playing in the top soccer championship in Spain
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effect of Football Practice on Bone Remodeling.
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.
Read the 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.
- Being tested
- Dual-energy X-ray Absorptiometry (DXA) scan
- Keywords
- Regional body composition, Testosterone, Cortisol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-energy X-ray Absorptiometry (DXA) scanDiagnostic test
Also called Fasting blood samples
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Jul 2021
- Primary completion10 Jul 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Body CompositionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Villarreal CF
- Responsible party
- Principal investigator, Isabel Almodóvar Fernández, Cardenal Herrera University
- Investigators
- Adolfo Muñoz Macho, MD, Study chair, Medical Services of Villarreal CF SAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839172
- Sponsor's protocol ID
- CMOTC
- Status last verified
- Mar 2022
- First submitted
- 7 Apr 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Football Practice on Bone Remodeling.
- ClinicalTrials.gov ID
- NCT04839172
- Acronym / sponsor ID
- CMOTC
- Keywords
- Regional body composition, Testosterone, Cortisol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Villarreal CF
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 10 Jul 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 9 Apr 2021 (actual)
- 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.
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.
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- male professional soccer players playing in the top soccer championship in Spain
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Dual-energy X-ray Absorptiometry (DXA) scanAlso: Fasting blood samplesLongitudinal 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. | Diagnostic test | – |
Primary outcome
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
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 9 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Adolfo Muñoz Macho, MD study chair
Medical Services of Villarreal CF SAD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Body Composition and Cortisol and Testosterone Levels, run by Cardenal Herrera University 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 4 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 9 Mar 2022. 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?
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). 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 9 Mar 2022.