NCT03870321

Brief Summary

Introduction. The prevalence of ankle injuries in basketball are high. The lack of balance in the ankle is one of the main causes that produces these injuries. The goal of core training is to increase the physical capacities of resistance strength in the abdomen and analyze if it produces improvement in proprioception in the ankle joint in basketball players. Objective. To evaluate the effectiveness of Core training to improve the strength of the abdomen and analyze if it produces improvement in proprioception in ankle of basketball players. Study design. Randomized, multicentric, single-blind clinical study with a follow-up period. Methods. The 30 participants recruited will be randomly assigned to the two study groups: experimental (Core training for strength in the abdomen) and control (without intervention). The treatment will last 4 weeks, with 3 weekly sessions, approximately 20 minutes each. There will be three evaluations (pre-intervention, post-intervention and follow-up). On the dependent variables: strength core resistance (evaluated with Trunk Flexor Test, Trunk Extender Test, and Side Bridge Test) and proprioception (measured with the Star Excursion Balance tests and Romberg test) With the Kolmogorov Smirnov statistical test we will calculate the normality and with the t-student test of paired data and an ANOVA of repeated measures, we will obtain the difference between the three evaluations and the intra and intersubject effect, respectively. Expected results. To observe improvement in strength in the abdomen and analyze if it produces improvement in proprioception in the ankle of basketball players.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

March 8, 2019

Last Update Submit

January 23, 2020

Conditions

Keywords

CoreStrengthProprioceptionAnkleBasketball

Outcome Measures

Primary Outcomes (1)

  • Change from baseline ankle proprioception after intervention and at month

    The Star excursion balance test will be used to measure ankle proprioception. It begins with a star drawn on the ground, while the subject will remain in a static position, placing his or her bare foot in the center of the star. During the execution of the test the subject will be asked to touch the farthest point possible with the tip of the first finger. The contact of the finger has to be clean, without supporting the weight or imbalance of the other foot, returning each time to the initial monopodal position. At each attempt the contact point will be recorded on the ground line. This exercise will be repeated three times and the average of the evaluations will be taken into account to obtain the value of the measurement in each one of the directions to be studied, with the final result being the average distance of all the attempts in each of the directions. The unit of measurement is the centimeter (the greater distance in centimeters, the better ankle proprioception).

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Secondary Outcomes (4)

  • Change from baseline strength of the flexor muscles of the abdomen after intervention and at month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

  • Change from baseline strength of the extensor muscles of the abdomen after intervention and at month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

  • Change from baseline strength of the lateral flexor muscles of the abdomen after intervention and at month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

  • Change from baseline ankle proprioception after intervention and at month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Study Arms (2)

Core training

EXPERIMENTAL

The subjects who are in the experimental group will carry out the Core training routine

Other: Core training

Control

NO INTERVENTION

The subjects who are in the control group will not receive intervention and will continue with their daily routine and training

Interventions

In the first week different types of abdominal exercises will be performed: standard, with trunk rotation, extension of the back raising the upper extremity of the body and legs, extension of the back raising one arm and the contralateral leg. In the same way, the subject will raise from the quadruped position one arm and the contralateral leg on each side, and we will ask for the exercise of the front plate, positioning itself in a position of four support points: feet and elbows. When performing the rear bridge exercise the subject will raise the trunk resting on both feet, while in the lateral bridge exercise will be done with support on the right and left side. All exercises will be done for 30 seconds, in 3 series). During the next three weeks we will continue with the same training, but for each week we will increase 10 seconds per exercise.

Core training

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Basketball players
  • Federated in the Community of Madrid
  • Male
  • With an age range of 18 to 40 years.

You may not qualify if:

  • Who have a musculoskeletal injury at the time of the study or who have suffered a lower limb injury in a period of three months before the study
  • That they are in an individualized personal training
  • Not signed the informed consent document.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Comunity of Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Somatosensory Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rubén Cuesta-Barriuso, PhD

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 12, 2019

Study Start

April 1, 2019

Primary Completion

May 15, 2019

Study Completion

June 20, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations