SoccerNCT03588065
Health Education for Physiotherapy in Soccer Players
A study testing FMS, TICS and CONFERENCE in people with Soccer, run by Cardenal Herrera University at 1 site in Colombia.
Trial summary
INTRODUCTION. Health education based on interventions with new information and communication technologies. OBJECTIVE. To compare the effectiveness of an educational physiotherapy intervention in footballers, in face-to-face mode (conference) versus an intervention mediated by ICT, on the risk of medical injury with… Read more about this study
- Who is it for?
- Ages 18 to 20 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Soccer
- What is being tested?
- FMS, TICS and CONFERENCE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteColombia
- Study dates
- 2 Jul 2017to 15 Nov 2017
- Phase
- Interventional
- 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 20 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Athletes over 18 years of age belonging to the La Equidad sports club.
- Athletes with a previous sporting age of more than three years.Athletes who have taken the entrance exam for the interdisciplinary team of the previous or initial physical condition of the La Equidad sports club.
- Resident in Bogotá or municipalities of Cundinamarca.
Who cannot join
- Alterations of perception or behavior that hinder educational interventions.
- Other co-morbidities reported by the user or in the clinical history of the sport that limit the intervention (Example: hearing loss, kyphosis, memory deficit or cognitive attention, visual limitation).
- Users who do not have training in educational computer skills.
- Not having a computer with an internet connection.
Trial locations and contacts
1 site in 1 country.
About this study
INTRODUCTION. Health education based on interventions with new information and communication technologies.
OBJECTIVE. To compare the effectiveness of an educational physiotherapy intervention in footballers, in face-to-face mode (conference) versus an intervention mediated by ICT, on the risk of medical injury with the Functional Movement Screen [FMS].
MATERIAL AND METHODS. A randomized clinical trial (RCT) was carried out. The population consisted of 100 participants divided into two groups (ICT n = 50) and (Conference n = 50), with an average age of 18.2 versus 18.3 years for a conference. and ICT respectively.
Read the detailed description
Recruitment phase: In this phase the athletes were contacted to explain the objectives of the study and the interventions; those who agreed to participate filled out the questionnaire to verify the inclusion and exclusion criteria, later those who met the criteria gave written informed consent. This phase was held in a week in the sports team club Initial evaluation phase: In this phase, the contact form and the general characteristics of the population were filled out and the initial evaluation of knowledge about sports injuries was done in all the participants of the investigation. Likewise, the participants were assigned to each of the two interventions at random. For the random assignment, the Excel 2010® program was used, where random numbers were assigned to the sampling frame.
Intervention phase: The educational intervention in health was developed from physiotherapy in each of the groups (conference or mediated by ICT) according to the allocation group as explained below.
Final evaluation phase: The final evaluation of knowledge about the prevention of injuries in football was made to both groups of the investigation.
- Conditions
- Soccer
- Being tested
- FMS, TICS, CONFERENCE
- Keywords
- public health, Soccer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMSDiagnostic test
The evaluation of the risk of sports injury was obtained from the score in the Functional Movement Screen test suite.
The Functional Movement Screen (FMS) is a battery of tests that allows the integral assessment of the risk of injury, evaluating the basic patterns of movement and motor control through the performance of seven tests in which the combination of force is reflected muscle, flexibility, range of motion range, coordination, balance and proprioception
TICSOther
The educational activities were directed to soccer players belonging to Equidad, Bogotá-Colombia. Computerized media were used within the reach of footballers, applied with professionals of physical activity sciences under blind study methodology, using the new tendencies of Information and Communication Technologies (ICT) in Health Education. The investigators counted on the advice of the group manager of knowledge of the secretary of the district of the city of Bogotá. In the educational intervention seven aspects were addressed, distributed in four weekly modules for a total of four months
CONFERENCEOther
The face-to-face educational intervention (conference) consisted of four educational sessions, distributed over four weeks during the sports transition period of the Equity sub-20 team. During these sessions, workshops (conferences) were held with the players following a face-to-face methodology . All these activities were concerted with the multidisciplinary team of the Equity football team and were carried out by the researcher at the University of La Sabana, a physiotherapist, who was studying the needs of the prevention of musculoskeletal injuries in football.
| Study group | Role | What they receive |
|---|---|---|
| attend education for TICS | Experimental | The educational activities were directed to soccer players belonging to Equidad, Bogotá-Colombia. Computerized media were used within the reach of footballers, applied with professionals of physical activity sciences under blind study methodology, using the new tendencies of Information and Communication Technologies (ICT) in Health Education. The investigators counted on the advice of the group manager of knowledge of the secretary of the district of the city of Bogotá. In the educational intervention seven aspects were addressed, distributed in four weekly modules for a total of four months Receives: Diagnostic Test: FMS; Other: TICS |
| attend education for conference | Active comparator | The intervention arm descriptionTHE CONFERENCE include face-to-face sessions focused on the four aspects mentioned above for ICT. To this end, the theoretical elements of the concepts under study were taken into account: human body movement, warm-up phases, postural hygiene, sports hygiene, nutrition and clothing.
The face-to-face sessions focused on the four aspects mentioned above for ICT. To this end, the theoretical elements of the concepts under study were taken into account: human body movement, warm-up phases, postural hygiene, sports hygiene, nutrition and clothing. Receives: Diagnostic Test: FMS; Other: CONFERENCE |
| attend for FMS | Sham comparator | The FMS test was applied in two moments with three blind evaluators physiotherapists with specialization in therapeutic physical activity and master in Physical Activity and Sports, with an experience of more than 5 years in the field of assessment of sport condition and clinical experience in sport greater than 6 years in sports clubs in the region. Receives: Diagnostic Test: FMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
SELF-AWARENESS QUESTIONNAIRE ON SPORTS INJURIES
A total of 17 questions were established, divided into seven categories of knowledge on the prevention of injuries, which should be addressed in the health education plan from Physiotherapy. The score was calculated as follows: each question answered correctly with the option of YES and NO had a point, the sum of the correct questions was made and divided by the number of questions. Using a rule of three this score was converted to a scale of 0 to 100.
Measured: 4 months
Secondary outcomes (1)
FMS
The scores of the seven movement patterns. If the athlete is able to make the movements without any compensation, receive a score of 3. If the athlete performs the movement with one or more compensations or with a difficulty to receive a score of 2. If the athlete is unable to reproduce the requested movement, receive a score of 1. If during the performance of the test the athlete presents pain, receive a score of zero and should be referred to a specialist. The maximum score for the sum of all movements is 21.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start2 Jul 2017
- Primary completion8 Oct 2017
- Study completion15 Nov 2017
Why it stopped: The study was stopped by insufficient funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SoccerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For the process of imparting health education strategies in face-to-face (conference) and ICT-mediated mode, a 4-week time was estimated where 4 educational sessions were held at a rate of one each week, lasting about 40 minutes, for part of two physiotherapists experts in the theme of injury prevention around the conceptual elements of human body movement, warm-up phases, postural hygiene, sports hygiene, nutrition and clothing. Interventions were carried out simultaneously in both groups of the study, so that one researcher taught the lecture modality in person (conference group), and the other supervised the participants while using the computers of the sports training institution.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JORGE ENRIQUE MORENO COLLAZOS, Cardenal Herrera University
- Investigators
- JORGE MORENO COLLAZOS, PHD, Principal investigator, universidad cardenal herrera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588065
- Sponsor's protocol ID
- TERAPIA MANUAL
- Status last verified
- Jul 2018
- First submitted
- 25 Jun 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: does not apply
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Education for Physiotherapy in Soccer Players
- ClinicalTrials.gov ID
- NCT03588065
- Acronym / sponsor ID
- TERAPIA MANUAL
- Conditions
- Soccer
- Keywords
- public health, Soccer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped by insufficient funds
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 2 Jul 2017 (actual)
- Primary completion
- 8 Oct 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 17 Jul 2018 (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.
INTRODUCTION. Health education based on interventions with new information and communication technologies.
OBJECTIVE. To compare the effectiveness of an educational physiotherapy intervention in footballers, in face-to-face mode (conference) versus an intervention mediated by ICT, on the risk of medical injury with the Functional Movement Screen [FMS].
MATERIAL AND METHODS. A randomized clinical trial (RCT) was carried out. The population consisted of 100 participants divided into two groups (ICT n = 50) and (Conference n = 50), with an average age of 18.2 versus 18.3 years for a conference. and ICT respectively.
Detailed description
Recruitment phase: In this phase the athletes were contacted to explain the objectives of the study and the interventions; those who agreed to participate filled out the questionnaire to verify the inclusion and exclusion criteria, later those who met the criteria gave written informed consent. This phase was held in a week in the sports team club Initial evaluation phase: In this phase, the contact form and the general characteristics of the population were filled out and the initial evaluation of knowledge about sports injuries was done in all the participants of the investigation. Likewise, the participants were assigned to each of the two interventions at random. For the random assignment, the Excel 2010® program was used, where random numbers were assigned to the sampling frame.
Intervention phase: The educational intervention in health was developed from physiotherapy in each of the groups (conference or mediated by ICT) according to the allocation group as explained below.
Final evaluation phase: The final evaluation of knowledge about the prevention of injuries in football was made to both groups of the investigation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- For the process of imparting health education strategies in face-to-face (conference) and ICT-mediated mode, a 4-week time was estimated where 4 educational sessions were held at a rate of one each week, lasting about 40 minutes, for part of two physiotherapists experts in the theme of injury prevention around the conceptual elements of human body movement, warm-up phases, postural hygiene, sports hygiene, nutrition and clothing. Interventions were carried out simultaneously in both groups of the study, so that one researcher taught the lecture modality in person (conference group), and the other supervised the participants while using the computers of the sports training institution.
| Arm | Type | Receives |
|---|---|---|
| attend education for TICS | Experimental | Diagnostic Test: FMS, Other: TICSThe educational activities were directed to soccer players belonging to Equidad, Bogotá-Colombia. Computerized media were used within the reach of footballers, applied with professionals of physical activity sciences under blind study methodology, using the new tendencies of Information and Communication Technologies (ICT) in Health Education. The investigators counted on the advice of the group manager of knowledge of the secretary of the district of the city of Bogotá. In the educational intervention seven aspects were addressed, distributed in four weekly modules for a total of four months |
| attend education for conference | Active comparator | Diagnostic Test: FMS, Other: CONFERENCEThe intervention arm descriptionTHE CONFERENCE include face-to-face sessions focused on the four aspects mentioned above for ICT. To this end, the theoretical elements of the concepts under study were taken into account: human body movement, warm-up phases, postural hygiene, sports hygiene, nutrition and clothing. The face-to-face sessions focused on the four aspects mentioned above for ICT. To this end, the theoretical elements of the concepts under study were taken into account: human body movement, warm-up phases, postural hygiene, sports hygiene, nutrition and clothing. |
| attend for FMS | Sham comparator | Diagnostic Test: FMSThe FMS test was applied in two moments with three blind evaluators physiotherapists with specialization in therapeutic physical activity and master in Physical Activity and Sports, with an experience of more than 5 years in the field of assessment of sport condition and clinical experience in sport greater than 6 years in sports clubs in the region. |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Athletes over 18 years of age belonging to the La Equidad sports club.
- Athletes with a previous sporting age of more than three years.Athletes who have taken the entrance exam for the interdisciplinary team of the previous or initial physical condition of the La Equidad sports club.
- Resident in Bogotá or municipalities of Cundinamarca.
Key exclusion criteria (4 listed)
- Alterations of perception or behavior that hinder educational interventions.
- Other co-morbidities reported by the user or in the clinical history of the sport that limit the intervention (Example: hearing loss, kyphosis, memory deficit or cognitive attention, visual limitation).
- Users who do not have training in educational computer skills.
- Not having a computer with an internet connection.
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 |
|---|---|---|
| FMSThe evaluation of the risk of sports injury was obtained from the score in the Functional Movement Screen test suite. The Functional Movement Screen (FMS) is a battery of tests that allows the integral assessment of the risk of injury, evaluating the basic patterns of movement and motor control through the performance of seven tests in which the combination of force is reflected muscle, flexibility, range of motion range, coordination, balance and proprioception | Diagnostic test | attend education for TICS, attend education for conference, attend for FMS |
| TICSThe educational activities were directed to soccer players belonging to Equidad, Bogotá-Colombia. Computerized media were used within the reach of footballers, applied with professionals of physical activity sciences under blind study methodology, using the new tendencies of Information and Communication Technologies (ICT) in Health Education. The investigators counted on the advice of the group manager of knowledge of the secretary of the district of the city of Bogotá. In the educational intervention seven aspects were addressed, distributed in four weekly modules for a total of four months | Other | attend education for TICS |
| CONFERENCEThe face-to-face educational intervention (conference) consisted of four educational sessions, distributed over four weeks during the sports transition period of the Equity sub-20 team. During these sessions, workshops (conferences) were held with the players following a face-to-face methodology . All these activities were concerted with the multidisciplinary team of the Equity football team and were carried out by the researcher at the University of La Sabana, a physiotherapist, who was studying the needs of the prevention of musculoskeletal injuries in football. | Other | attend education for conference |
Primary outcome
SELF-AWARENESS QUESTIONNAIRE ON SPORTS INJURIES
Time frame: 4 months
A total of 17 questions were established, divided into seven categories of knowledge on the prevention of injuries, which should be addressed in the health education plan from Physiotherapy. The score was calculated as follows: each question answered correctly with the option of YES and NO had a point, the sum of the correct questions was made and divided by the number of questions. Using a rule of three this score was converted to a scale of 0 to 100.
1 secondary outcome
FMS
Time frame: 4 months
Results and safety
The study was stopped early (reason given: The study was stopped by insufficient funds). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: No. does not apply
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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.
JORGE MORENO COLLAZOS, PHD principal investigator
universidad cardenal herrera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMS, TICS and CONFERENCE in people with Soccer, run by Cardenal Herrera University at 1 site in Colombia.
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: stopped early, as of the sponsor's last update on 18 Jul 2018. 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 Colombia. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The study was stopped by insufficient funds). Results are not available in the source record.
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?
SELF-AWARENESS QUESTIONNAIRE ON SPORTS INJURIES (time frame: 4 months). 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 18 Jul 2018.