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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03617887
Other study ID # COREGLUTFEM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date August 1, 2018

Study information

Verified date September 2018
Source Real Fundación Victoria Eugenia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date August 1, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Spain Royal Victoria Eugenia Foundation Madrid Madird

Sponsors (1)

Lead Sponsor Collaborator
Real Fundación Victoria Eugenia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary 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 Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary 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. Screening visit, within the first seven days after treatment and after one month follow-up visit