Young Soccer PlayersCOREGLUTFEMNCT03617887
Isometric Abdominal and Specific Gluteus Medius Work in Soccer Players
A study testing Experimental group in people with Young Soccer Players, run by Real Fundación Victoria Eugenia at 1 site in Spain.
Trial summary
The problems of lack of lumbo-pelvic stability, as well as weakness or mobile restriction of the adductor muscles, may be the origin of lower limb injuries. Both intrinsic and extrinsic factors are key in the probability of suffering an imbalance. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Young Soccer Players
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2018to 1 Aug 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 35 years
- Federated in the Royal Football Federation of Madrid currently and with a minimum of 4 years
- Without any previous pathology or during the experimental period
- Signed the informed consent
Who cannot join
- Not have current or previous pathology in any region of the lower limb during the last 6 months
- Inability or inability to comply with the demands of the study in terms of follow-up or problems of involvement
- Players under pharmacological treatment or exercising a physiotherapy treatment parallel to the development of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Isometric Abdominal and Specific Gluteus Medius Work in Soccer Players. A Randomized Pilot Study
The problems of lack of lumbo-pelvic stability, as well as weakness or mobile restriction of the adductor muscles, may be the origin of lower limb injuries. Both intrinsic and extrinsic factors are key in the probability of suffering an imbalance. A protocol of abdominal isometric strength, accompanied by specific exercises of the gluteus medius, can be useful in order to prevent such dysfunctions.
The objective is to compare the efficacy of abdominal isometric work against the specific work of gluteus medius in the improvement of lumbo-pelvic stability and strength and elasticity of the adductor muscles.
Read more
Study design. Randomized, longitudinal, experimental, prospective, multicentre and single-blind clinical trial. It will take place at the facilities of the Soccer Club Fuenlabrada S. A. D. and the European University of Madrid.
The subjects will be randomly divided into two groups: control group and experimental group. The intervention period will last eight weeks, performing 2 weekly sessions, of approximately 20 minutes (depending on the group to which each subject belongs). The variables to be evaluated before and after the intervention will be the lumbo-pelvic stability and the strength and elasticity of the adductor muscles. For the statistical analysis, the SPSS program version 19.0 will be used.
It is expected to find how gluteal work produces improvements in lumbo-pelvic stability, as well as an increase in strength and adduction elasticity.
Read the detailed description
Each session will last 20 minutes, taking place during 2 days a week, in a period of 8 weeks. The intervention will be carried out at the beginning of the training session. This intervention consists of an abdominal work protocol, and a gluteal work protocol added to the previous protocol, performed by the control group and the experimental group, respectively.
- Conditions
- Young Soccer Players
- Being tested
- Experimental group, Control group
- Keywords
- Core, Isometric abdominal, Gluteus medius, Adductor, Lumbo-pelvic stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Plank exercise, Lateral plank exercise, Bird dog exercise, Pelvic drop exercise, and Stabilization of the middle gluteus in the knee valgus.
The intervention consisted of sessions of approximately 20 minutes, taking place 2 days a week, for 8 weeks. The exercises were performed at the beginning of the training session, and consisted of a work of the abdominal region in the control group, and a specific work of gluteus medius, added to the previous one, in the experimental group.
Control groupOther
Plank exercise, Lateral plank exercise and Bird dog exercise. The intervention consisted of sessions of approximately 20 minutes, taking place 2 days a week, for 8 weeks. The exercises were performed at the beginning of the training session, and consisted of a work of the abdominal region.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Plank exercise, Lateral plank exercise, Bird dog exercise, Pelvic drop exercise, and Stabilization of the middle gluteus in the knee valgus: Receives: Other: Experimental group |
| Control group | Experimental | Plank exercise, Lateral plank exercise and Bird dog exercise Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline lumbo-pelvic stability after treatment and at 1 month
With a universal goniometer, the subject slightly lowers the extended legs, and the moment the lumbar spine loses contact with the ground, the angle is measured whose legs form with the ground
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (2)
Change from baseline elasticity of the adductor muscles after treatment and at 1 month
With the subject sitting on the floor, and both legs extended and separated as much as possible, passively, place the goniometer with the axis parallel to the floor at the level of the pubic symphysis and both arms moving along the axis of the femur. The normative values: the normal range is from 0º to 180º
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline adductor muscle strength after treatment and at 1 month
With a manual dynamometer, hooked to a fixed point and perpendicular and lateral to the leg to be treated, at the height of the distal third of the tibia, and the subject standing, the subject had to perform a hip adduction, generating a Progressive maximum isometric contraction.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Mar 2018
- Primary completion31 May 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Young Soccer PlayersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 25 subjects will be randomized into both groups: experimental and control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Real Fundación Victoria Eugenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617887
- Sponsor's protocol ID
- COREGLUTFEM
- Acronym
- COREGLUTFEM
- Status last verified
- Sep 2018
- First submitted
- 1 Aug 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guerrero-Tapia H, Martin-Baeza R, Cuesta-Barriuso R. Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-Pelvic Stability and Adductor Strength in Female Soccer Players. A Randomized Controlled Study. Int J Environ Res Public Health. 2021 Feb 5;18(4):1528. doi: 10.3390/ijerph18041528.
PubMed 33562743
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isometric Abdominal and Specific Gluteus Medius Work in Soccer Players. A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03617887
- Acronym / sponsor ID
- COREGLUTFEM / COREGLUTFEM
- Conditions
- Young Soccer Players
- Keywords
- Core, Isometric abdominal, Gluteus medius, Adductor, Lumbo-pelvic stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Real Fundación Victoria EugeniaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 7 Aug 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 problems of lack of lumbo-pelvic stability, as well as weakness or mobile restriction of the adductor muscles, may be the origin of lower limb injuries. Both intrinsic and extrinsic factors are key in the probability of suffering an imbalance. A protocol of abdominal isometric strength, accompanied by specific exercises of the gluteus medius, can be useful in order to prevent such dysfunctions.
The objective is to compare the efficacy of abdominal isometric work against the specific work of gluteus medius in the improvement of lumbo-pelvic stability and strength and elasticity of the adductor muscles.
Study design. Randomized, longitudinal, experimental, prospective, multicentre and single-blind clinical trial. It will take place at the facilities of the Soccer Club Fuenlabrada S. A. D. and the European University of Madrid.
The subjects will be randomly divided into two groups: control group and experimental group. The intervention period will last eight weeks, performing 2 weekly sessions, of approximately 20 minutes (depending on the group to which each subject belongs). The variables to be evaluated before and after the intervention will be the lumbo-pelvic stability and the strength and elasticity of the adductor muscles. For the statistical analysis, the SPSS program version 19.0 will be used.
It is expected to find how gluteal work produces improvements in lumbo-pelvic stability, as well as an increase in strength and adduction elasticity.
Detailed description
Each session will last 20 minutes, taking place during 2 days a week, in a period of 8 weeks. The intervention will be carried out at the beginning of the training session. This intervention consists of an abdominal work protocol, and a gluteal work protocol added to the previous protocol, performed by the control group and the experimental group, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 25 subjects will be randomized into both groups: experimental and control
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental groupPlank exercise, Lateral plank exercise, Bird dog exercise, Pelvic drop exercise, and Stabilization of the middle gluteus in the knee valgus: |
| Control group | Experimental | Other: Control groupPlank exercise, Lateral plank exercise and Bird dog exercise |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 35 years
- Federated in the Royal Football Federation of Madrid currently and with a minimum of 4 years
- Without any previous pathology or during the experimental period
- Signed the informed consent
Key exclusion criteria (3 listed)
- Not have current or previous pathology in any region of the lower limb during the last 6 months
- Inability or inability to comply with the demands of the study in terms of follow-up or problems of involvement
- Players under pharmacological treatment or exercising a physiotherapy treatment parallel to the development of the study
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 |
|---|---|---|
| Experimental groupPlank exercise, Lateral plank exercise, Bird dog exercise, Pelvic drop exercise, and Stabilization of the middle gluteus in the knee valgus. The intervention consisted of sessions of approximately 20 minutes, taking place 2 days a week, for 8 weeks. The exercises were performed at the beginning of the training session, and consisted of a work of the abdominal region in the control group, and a specific work of gluteus medius, added to the previous one, in the experimental group. | Other | Experimental group |
| Control groupPlank exercise, Lateral plank exercise and Bird dog exercise. The intervention consisted of sessions of approximately 20 minutes, taking place 2 days a week, for 8 weeks. The exercises were performed at the beginning of the training session, and consisted of a work of the abdominal region. | Other | Control group |
Primary outcome
Change from baseline lumbo-pelvic stability after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
With a universal goniometer, the subject slightly lowers the extended legs, and the moment the lumbar spine loses contact with the ground, the angle is measured whose legs form with the ground
2 secondary outcomes
Change from baseline elasticity of the adductor muscles after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline adductor muscle strength after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
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 Sep 2018.
- Derived from this study: PubMed 33562743Guerrero-Tapia H, Martin-Baeza R, Cuesta-Barriuso R. Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-Pelvic Stability and Adductor Strength in Female Soccer Players. A Randomized Controlled Study. Int J Environ Res Public Health. 2021 Feb 5;18(4):1528. doi: 10.3390/ijerph18041528.
- 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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Young Soccer Players, run by Real Fundación Victoria Eugenia 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 4 inclusion and 3 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 Sep 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?
Change from baseline lumbo-pelvic stability after treatment and at 1 month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03617887, which also lists 1 linked publication.
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 Sep 2018.