NCT05206786

Brief Summary

The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. A total of 92 female basketball players aged between 12 and 25 will be selected and randomized in two different groups. The control group will carry out a conventional preventive work out and the experimental group will carry out a specific strengthening program for the gluteus maximus in addition to the conventional preventive exercises. The treatment will take place during the basketball club season and will last 4 months, from January to April 2022. The objective is to evaluate the effectiveness of the inclusion of a specific gluteus maximus strength program in the conventional preventive work to improve the dynamic stability and to reduce the injury rate and pain in female basketball players.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

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

January 6, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

May 3, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

January 6, 2022

Last Update Submit

May 2, 2022

Conditions

Keywords

Dynamic Postural ControlGluteus MaximusLower limbInjury prevention

Outcome Measures

Primary Outcomes (1)

  • Dynamic stability change assessed by a modified version of the Star Excursion Balance Test (SEBT). For this, Octobo-Balance device will be used.

    Five lower limb excursion directions are going to be analysed: anterior (SEBT-A), medial (SEBT-M), posterior (SEBT-P), posteromedial (SEBT-PM) and posterolateral (SEBT-PL), with all these excursion directions and the legs' length of each player we will calculate the sum of them. The device system consists of an extending measuring tape magnetized to an octagon-shaped platform which allows to measure the different directions. There is a marked point in the middle of the octagon where players must put one of their feet properly and push the measuring tape with the other one. Players will have to go as far as possible in each direction without touching de floor or lifting the foot that it's set on the octagon. There will be three attempts in all the excursion directions, and it will be done for each leg.

    Baseline and 4 months later

Secondary Outcomes (5)

  • Change in the rate of lower limb injuries measured with a Daily Injury Report

    Daily from baseline until the end of the research study 4 months later

  • Pain change measured with the Visual Analogue Scale

    Baseline and 4 months later

  • Vertical Jump Height using the app MyJump2

    Baseline and 4 months later

  • Dynamic knee valgus measured with the programme Kinovea

    Baseline and 4 months later

  • Treatment adherence through an exercise tracking diary

    Weekly from baseline until the end of the research study 4 months later

Study Arms (2)

Control group. Conventional preventive work out

EXPERIMENTAL
Other: Conventional preventive work out

Intervention group. Gluteus maximus strengthening specific program

EXPERIMENTAL
Other: Conventional preventive work outOther: Gluteus maximus strengthening specific program

Interventions

Female players in the control group will carry out a conventional preventive work that is organised in 3 training days per week. First training session includes preventive strength and proprioception exercises. Junior and senior teams (above 16 years old) will also do plyometrics exercises. In the second training session, players will do preventive strength exercises with an increased load compared to the previous session and proprioception exercises. Junior and senior players will also do anaerobic work. In the third session, players will perform reaction speed exercises.

Control group. Conventional preventive work outIntervention group. Gluteus maximus strengthening specific program

Female players will carry out a gluteus maximus strengthening work out in addition to the control group programme. Of the following four exercises, the first and the third ones will be done on the first training session and the second and the fourth exercises will be done on the second one. Dosage will be 2 sets of 10 repetitions for each leg. 1. Clam Shell: Lateral decubitus with the knees and hips bend, the working leg placed on top of the other. Separate this knee while feet stay in contact. 2. Unilateral gluteal bridge: Supine decubitus with one foot flat on the floor and bent knee. This leg pushes the ground with the foot until the pelvis is lifted while the other leg remains straight. 3. Quadruped hip extension with knee extension : Quadruped on forearms. Straighten the hip by bringing the whole leg up and back with knee extension. 4. Quadruped hip extension with bent knee: Performed as the previous one, but during this one, the knee of the working leg is bent at 90º.

Intervention group. Gluteus maximus strengthening specific program

Eligibility Criteria

Age12 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female basketball players belonging to a sports club.
  • Female basketball players between 12 and 25 years old.

You may not qualify if:

  • Acute lower limb injuries at the start of the study.
  • Surgery on the lower limb in the previous year.
  • Injuries or diseases that prevent the correct performance of the evaluation tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandra Sánchez

Alcalá de Henares, Madrid, 28801, Spain

Location

Study Officials

  • Sandra Sánchez

    University of Alcalá, Madrid, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2022

First Posted

January 25, 2022

Study Start

January 10, 2022

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

May 3, 2022

Record last verified: 2022-05

Locations