Isometric Abdominal and Specific Gluteus Medius Work in Soccer Players (COREGLUTFEM)

September 11, 2018 updated by: Real Fundación Victoria Eugenia

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madird
      • Madrid, Madird, Spain, 28029
        • Royal Victoria Eugenia Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Plank exercise, Lateral plank exercise, Bird dog exercise, Pelvic drop exercise, and Stabilization of the middle gluteus in the knee valgus:
Other: Experimental group

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.
Experimental: Control group
Plank exercise, Lateral plank exercise and Bird dog exercise
Other: Control group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Screening visit, within the first seven days after treatment and after one month follow-up visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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.
Screening visit, within the first seven days after treatment and after one month follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Real Fundación Victoria Eugenia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COREGLUTFEM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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