ElectrocardiogramAIPROFBNCT05872945
Model-based Systems for Professional Football Teams, Aimed at Optimizing Health and Performance
An observational study of Electrocardiogram and Arrhythmias, Cardiac, run by RCD Mallorca SAD at 1 site in Spain.
Trial summary
LIST OF PLANNED ORIGINAL PUBLICATIONS 1. T wave inversion detection with machine learning to prevent sudden death in professional football players. 2. Machine learning applied to biological parameters for control and advisory in professional football players (Machine learning applied to biological parameters for… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Electrocardiogram, Arrhythmias, Cardiac
- What is being tested?
- Electrocardiogram
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2019to 30 Jul 2024
- 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 45 years
- Men only
- No healthy volunteers
- Adult
Study population: Pro Football Players
Who may be able to join
- Healthy young and professional players of legal age who play their role in professional football teams.
Who cannot join
- Players who are not a regular part of these professional teams.
- Players with known pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Implementation of Model-based Systems for Professional Football Teams, Aimed at Optimizing Health and Performance
LIST OF PLANNED ORIGINAL PUBLICATIONS
- T wave inversion detection with machine learning to prevent sudden death in professional football players.
- Machine learning applied to biological parameters for control and advisory in professional football players (Machine learning applied to biological parameters for control and advisory in professional football players.)
- Machine learning applied to sport geolocation systems for injury prevention in professional football players.
Read the detailed description
- Introduction The approach of this project arises from the concern to use intelligence systems artificial intelligence and machine learning in professional sports as assistance for the optimization of health and performance in professional soccer players. In professional sport, increasing physical, biological and physiological efforts are required and we need help tools.
In this regard, the proposal of several publications within the project has been raised:
- Detection of T-wave inversion with machine learning to prevent sudden death in professional soccer players. Players undergo various pre-competitive screening tests to assess their state of health, specifically one of them is a resting 12-lead electrocardiogram. Based on the waveform findings in this complementary test, the risk of a professional athlete and the need for more complementary tests can be classified (Drezner et al., 2017). Our proposal is to reanalyze these tests and subject them to a machine learning mathematical model that is capable of detecting T wave inversions in said leads and presenting the results and recommendations in accordance with international criteria for electrocardiographic study in athletes.
- Machine learning applied to biological parameters for control and advice in professional soccer players. During the season, routine analyzes are carried out to control biochemical parameters related to health and performance that fluctuate or change throughout the season: vitamin D, vitamin B12, vitamin B9, ferritin, etc. (Galan et al. ., 2012). Said data will be subjected to a machine learning procedure that can notify us of alterations in the habitual pattern of the players and that can cause alterations in performance, even generating pathologies.
- Machine learning applied to sports geolocation systems for the prevention of injuries in professional soccer players.
The data obtained during training sessions and matches regarding physical data such as duration, distance, distance at different speeds, training density, etc. Which are provided by sports geolocation systems, are of great importance when studying the effort and performance profile of each player. Obtaining the player's performance profile standardized according to the training day, we can detect adverse situations such as: over-training or lack of physical condition. Warning and alarm systems aimed at injury prevention can be designed. (Rossi, Pappalardo, Marcello, Javier, \& May, 2017).
- Description The studies will be implemented by implementing artificial intelligence and machine learning systems on the physical, biological and physiological data collected during the routine sports and health activity of the professional football players in the 2019-20 and 2020-21, 2021-22, 2022-23 y 2023-24 seasons.
2.1 General Objectives
- Evaluate the installation of artificial intelligence systems such as automatic learning to obtain models and results in the interpretation of physical, biomedical and physiological parameters of the players.
- Develop advisory/advertising systems in the area of health and performance based on profiles.
- Practical application The project has great potential for practical applicability and could generate a paradigm shift, since it is based on the generation of mathematical and/or programming models that will help in health controls and sports load controls that are applied to professional soccer players. A notable aspect is the possible improvement in the calculation of the probabilistic weights of the risk factors on health and performance.
- Conditions
- Electrocardiogram, Arrhythmias, Cardiac
- Being tested
- Electrocardiogram
- Keywords
- Artificial Intelligence, Performance, Pro Football Players, Sudden Death Prevention
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiogramDiagnostic test
Also called Blood Analitycs, GPS Data
Study by Artificial Intelligence the biosignal or biodata from profesional football players
What is being measured
The primary outcome is the main question the study is designed to answer.
Waves Detection
Detection waves changes in the electrocardiogram from pro football players
Measured: 2023-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jul 2019
- Primary completion1 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectrocardiogramStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- RCD Mallorca SAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adolfo Munoz Macho, Dr., Principal investigator, RCD Mallorca SAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872945
- Sponsor's protocol ID
- 1573N19
- Acronym
- AIPROFB
- Status last verified
- Nov 2024
- First submitted
- 2 May 2023
- Last updated
- 13 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is to generate an anonymous ECG, blood data and GPS Data from football players and share the dataset in XML or CSV format
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of Model-based Systems for Professional Football Teams, Aimed at Optimizing Health and Performance
- ClinicalTrials.gov ID
- NCT05872945
- Acronym / sponsor ID
- AIPROFB / 1573N19
- Conditions
- Electrocardiogram, Arrhythmias, Cardiac
- Keywords
- Artificial Intelligence, Performance, Pro Football Players, Sudden Death Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- RCD Mallorca SADUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 24 May 2023 (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.
LIST OF PLANNED ORIGINAL PUBLICATIONS
- T wave inversion detection with machine learning to prevent sudden death in professional football players.
- Machine learning applied to biological parameters for control and advisory in professional football players (Machine learning applied to biological parameters for control and advisory in professional football players.)
- Machine learning applied to sport geolocation systems for injury prevention in professional football players.
Detailed description
- Introduction The approach of this project arises from the concern to use intelligence systems artificial intelligence and machine learning in professional sports as assistance for the optimization of health and performance in professional soccer players. In professional sport, increasing physical, biological and physiological efforts are required and we need help tools.
In this regard, the proposal of several publications within the project has been raised:
- Detection of T-wave inversion with machine learning to prevent sudden death in professional soccer players. Players undergo various pre-competitive screening tests to assess their state of health, specifically one of them is a resting 12-lead electrocardiogram. Based on the waveform findings in this complementary test, the risk of a professional athlete and the need for more complementary tests can be classified (Drezner et al., 2017). Our proposal is to reanalyze these tests and subject them to a machine learning mathematical model that is capable of detecting T wave inversions in said leads and presenting the results and recommendations in accordance with international criteria for electrocardiographic study in athletes.
- Machine learning applied to biological parameters for control and advice in professional soccer players. During the season, routine analyzes are carried out to control biochemical parameters related to health and performance that fluctuate or change throughout the season: vitamin D, vitamin B12, vitamin B9, ferritin, etc. (Galan et al. ., 2012). Said data will be subjected to a machine learning procedure that can notify us of alterations in the habitual pattern of the players and that can cause alterations in performance, even generating pathologies.
- Machine learning applied to sports geolocation systems for the prevention of injuries in professional soccer players.
The data obtained during training sessions and matches regarding physical data such as duration, distance, distance at different speeds, training density, etc. Which are provided by sports geolocation systems, are of great importance when studying the effort and performance profile of each player. Obtaining the player's performance profile standardized according to the training day, we can detect adverse situations such as: over-training or lack of physical condition. Warning and alarm systems aimed at injury prevention can be designed. (Rossi, Pappalardo, Marcello, Javier, \& May, 2017).
- Description The studies will be implemented by implementing artificial intelligence and machine learning systems on the physical, biological and physiological data collected during the routine sports and health activity of the professional football players in the 2019-20 and 2020-21, 2021-22, 2022-23 y 2023-24 seasons.
2.1 General Objectives
- Evaluate the installation of artificial intelligence systems such as automatic learning to obtain models and results in the interpretation of physical, biomedical and physiological parameters of the players.
- Develop advisory/advertising systems in the area of health and performance based on profiles.
- Practical application The project has great potential for practical applicability and could generate a paradigm shift, since it is based on the generation of mathematical and/or programming models that will help in health controls and sports load controls that are applied to professional soccer players. A notable aspect is the possible improvement in the calculation of the probabilistic weights of the risk factors on health and performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pro Football Players
Key inclusion criteria (1 listed)
- Healthy young and professional players of legal age who play their role in professional football teams.
Key exclusion criteria (2 listed)
- Players who are not a regular part of these professional teams.
- Players with known pathology.
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 |
|---|---|---|
| ElectrocardiogramAlso: Blood Analitycs, GPS DataStudy by Artificial Intelligence the biosignal or biodata from profesional football players | Diagnostic test | – |
Primary outcome
Waves Detection
Time frame: 2023-2024
Detection waves changes in the electrocardiogram from pro football players
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 13 Nov 2024.
- Repository to view the datasetLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The plan is to generate an anonymous ECG, blood data and GPS Data from football players and share the dataset in XML or CSV format
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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 Munoz Macho, Dr. principal investigator
RCD Mallorca 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 Electrocardiogram and Arrhythmias, Cardiac, run by RCD Mallorca SAD 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 1 inclusion and 2 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 13 Nov 2024. 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?
Waves Detection (time frame: 2023-2024). 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 13 Nov 2024.