Sports Physical TherapyNCT03513978
Effects of Two Multimodal-programs of Exercises in Male Soccer Players.
A study testing IAI Exercises Protocol and FIFA 11+ in people with Sports Physical Therapy, run by University of Alcala at 1 site in Spain.
Trial summary
The prevention of injuries has a close relation with the proprioception. In this sense, the proprioception is defined as the information about the corporal and segmental movement, as well as the position of the body and the corporal segments of oneself in the space. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- IAI Exercises Protocol and FIFA 11+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 30 Apr 2018to 1 Nov 2018
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Soccer Players inscribed in Madrid's Soccer Confederation, who have not been sufferd any injury in the last three months and had been trainning regularly in the last six weeks.
Who cannot join
- Soccer Players who had been suffered any severe injury in the last six months like (1) fracture in the low limb, (2) ACL injury, (3) grade III ankle sprain or (4) any surgical intervention in the low limb.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Plaza de los Irlandeses, Nº 12, 2º C
Alcalá de Henares, Madrid, 28801
About this study
Official title: Comparison of the Effects Between Two Multimodal-programs of Exercises on Joint Position Sense, Dynamic Postural Balance and Counter Movement Jump in Male Soccer Players.
The prevention of injuries has a close relation with the proprioception. In this sense, the proprioception is defined as the information about the corporal and segmental movement, as well as the position of the body and the corporal segments of oneself in the space. Some authors divide the proprioception into kinesthesia and the Joint Position Sense (JPS).
The hypothesis of the study is the implantation of a progressive multimodal exercise protocol with transferences to sport in the trainings of amateur male soccer players in the age range from 18 to 30 years, can decrease the adverse effects of the fatigue during the high intensity activities and its relation with the JPS. Due to the close relation between fatigue and incidence of injuries, the obtaining of positive results could be an important finding for the design of prevention and rehabilitation protocols in soccer.
- Conditions
- Sports Physical Therapy
- Being tested
- IAI Exercises Protocol, FIFA 11+
- Keywords
- Soccer, Prevention injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IAI Exercises ProtocolOther
Progressive exercises to improve the strength and propioception of the male soccer players.
FIFA 11+Other
Progressive exercises protocol to prevent injuries in male soccer players which has been created by "FIFA". It is based in different body wieght exercises to improve the neuromuscular control and stabilization.
| Study group | Role | What they receive |
|---|---|---|
| IAI Protocol | Experimental | A progressive exercises with transference to sport protocol, oriented to improve the proprioception. Receives: Other: IAI Exercises Protocol |
| FIFA 11+ Protocol | Active comparator | A typical exercises protocol to soccer Receives: Other: FIFA 11+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Position Sense of the knee
A digital inclinometer (range measured in degreesº) was used to assess knee Joint Position Sense in a Closed Kinetic Chain using an active modality (athletes actively reached and maintained the knee). The athletes did three trials to the target position. The average of three trials was used to compared with the target position to obtain the absolute error and relative error.
Measured: Was measured at baseline (realized before the training), post-treatment (six weeks, realized before the training), ten weeks (before the training) and three months (realized before the trainng)
Joint Position Sense of the knee after the training
A digital inclinometer (range measured in degreesº) was used to assess knee Joint Position Sense in a Closed Kinetic Chain using an active modality (athletes actively reached and maintained the knee). The athletes did three trials to the target position. The average of three trials was used to compared with the target position to obtain the absolute error and relative error.
Measured: Was measured at baseline (realized after the training), post-treatment (six weeks, realized after the training) and three months (realized after the trainng)
Secondary outcomes (3)
Fatigue
The effort perception was measured with Borg Rating of Perceived Exertion Scale (Borg RPE), a 15-point single-item scale ranging from 6 to 20 (with anchors ranging from 6 "No exertion" to 20 "Maximum exertion") (little or no effort) to 20 (maximun exertion) scores
Measured: Was measured at baseline (after the training), post-treatment (six weeks, after the training), and three months (after the training
Lateral Step Down Test
Five consecutive test repetitions were then performed. The examiner were positioned 3 m in front of the subject during the test. The examiner evaluated the performance of the test simultaneously and scored the test on a 6-point scale (0-5), according to the criteria outlined by Piva et al. A total score of 0 to 1 was classified as "good" quality of movement, a total score of 2 to 3 was classified as "moderate" quality of movement, and a total score of 4 to 5 was classified as "poor" quality of movement.
Measured: Was measured at baseline (realized before and after the training), post-treatment (six weeks, realized before and after the training), ten weeks (realized only before the training) and three months (realized before and after the training
Counter movement jump
Measured by app "My Jump 2", participants performed each CMJ with hands on their hips, starting from a static standing position and with their legs straight during the flight phase of the jump. The landing was performed simultaneously with either feet keeping ankle dorsiflexion. Participants were instructed to jump as high as possible.
Measured: Was measured at baseline (realized before and after the training), post-treatment (six weeks, realized before and after the training), ten weeks (realized only before the training) and three months (realized before and after the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start30 Apr 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Physical TherapyStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Collaborators
- Colegio de Fisioterapeutas de la Comunidad de Madrid
- Responsible party
- Principal investigator, Marcos Jose Navarro Santana, University of Alcala
- Investigators
- Marcos Jose Navarro Santana, MSc, Principal investigator, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513978
- Sponsor's protocol ID
- Undefined
- Status last verified
- Nov 2018
- First submitted
- 26 Mar 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects Between Two Multimodal-programs of Exercises on Joint Position Sense, Dynamic Postural Balance and Counter Movement Jump in Male Soccer Players.
- ClinicalTrials.gov ID
- NCT03513978
- Acronym / sponsor ID
- Undefined
- Conditions
- Sports Physical Therapy
- Keywords
- Soccer, Prevention injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Collaborators
- Colegio de Fisioterapeutas de la Comunidad de Madrid
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 2 May 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.
The prevention of injuries has a close relation with the proprioception. In this sense, the proprioception is defined as the information about the corporal and segmental movement, as well as the position of the body and the corporal segments of oneself in the space. Some authors divide the proprioception into kinesthesia and the Joint Position Sense (JPS).
The hypothesis of the study is the implantation of a progressive multimodal exercise protocol with transferences to sport in the trainings of amateur male soccer players in the age range from 18 to 30 years, can decrease the adverse effects of the fatigue during the high intensity activities and its relation with the JPS. Due to the close relation between fatigue and incidence of injuries, the obtaining of positive results could be an important finding for the design of prevention and rehabilitation protocols in soccer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IAI Protocol | Experimental | Other: IAI Exercises ProtocolA progressive exercises with transference to sport protocol, oriented to improve the proprioception. |
| FIFA 11+ Protocol | Active comparator | Other: FIFA 11+A typical exercises protocol to soccer |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Soccer Players inscribed in Madrid's Soccer Confederation, who have not been sufferd any injury in the last three months and had been trainning regularly in the last six weeks.
Key exclusion criteria (1 listed)
- Soccer Players who had been suffered any severe injury in the last six months like (1) fracture in the low limb, (2) ACL injury, (3) grade III ankle sprain or (4) any surgical intervention in the low limb.
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 |
|---|---|---|
| IAI Exercises ProtocolProgressive exercises to improve the strength and propioception of the male soccer players. | Other | IAI Protocol |
| FIFA 11+Progressive exercises protocol to prevent injuries in male soccer players which has been created by "FIFA". It is based in different body wieght exercises to improve the neuromuscular control and stabilization. | Other | FIFA 11+ Protocol |
Primary outcome
Joint Position Sense of the knee
Time frame: Was measured at baseline (realized before the training), post-treatment (six weeks, realized before the training), ten weeks (before the training) and three months (realized before the trainng)
A digital inclinometer (range measured in degreesº) was used to assess knee Joint Position Sense in a Closed Kinetic Chain using an active modality (athletes actively reached and maintained the knee). The athletes did three trials to the target position. The average of three trials was used to compared with the target position to obtain the absolute error and relative error.
Joint Position Sense of the knee after the training
Time frame: Was measured at baseline (realized after the training), post-treatment (six weeks, realized after the training) and three months (realized after the trainng)
A digital inclinometer (range measured in degreesº) was used to assess knee Joint Position Sense in a Closed Kinetic Chain using an active modality (athletes actively reached and maintained the knee). The athletes did three trials to the target position. The average of three trials was used to compared with the target position to obtain the absolute error and relative error.
3 secondary outcomes
Fatigue
Time frame: Was measured at baseline (after the training), post-treatment (six weeks, after the training), and three months (after the training
Lateral Step Down Test
Time frame: Was measured at baseline (realized before and after the training), post-treatment (six weeks, realized before and after the training), ten weeks (realized only before the training) and three months (realized before and after the training
Counter movement jump
Time frame: Was measured at baseline (realized before and after the training), post-treatment (six weeks, realized before and after the training), ten weeks (realized only before the training) and three months (realized before and after the training
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 6 Nov 2018.
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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.
Marcos Jose Navarro Santana, MSc principal investigator
Alcala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IAI Exercises Protocol and FIFA 11+ in people with Sports Physical Therapy, run by University of Alcala 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 1 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 6 Nov 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 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?
Joint Position Sense of the knee (time frame: Was measured at baseline (realized before the training), post-treatment (six weeks, realized before the training), ten weeks (before the training) and three months (realized before the trainng)). The study lists 2 primary outcomes in all. 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 6 Nov 2018.