- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03513978
Effects of Two Multimodal-programs of Exercises in Male Soccer Players.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Alcalá de Henares, Madrid, Spain, 28801
- Plaza de los Irlandeses, Nº 12, 2º C
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: IAI Protocol
A progressive exercises with transference to sport protocol, oriented to improve the proprioception.
|
Progressive exercises to improve the strength and propioception of the male soccer players.
|
ACTIVE_COMPARATOR: FIFA 11+ Protocol
A typical exercises protocol to soccer
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
Was measured at baseline (realized after the training), post-treatment (six weeks, realized after the training) and three months (realized after the trainng)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue
Time Frame: Was measured at baseline (after the training), post-treatment (six weeks, after the training), and three months (after the training
|
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
|
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
|
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.
|
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
|
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.
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcos Jose Navarro Santana, MSc, Alcala University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Undefined
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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