BasketballNCT05206786
A Gluteus Maximus Strength Exercise Effectiveness for Improving Dynamic Postural Control in Female Basketball Players
A study testing Conventional preventive work out and Gluteus maximus strengthening specific program in people with Basketball, run by University of Jaén at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Basketball
- What is being tested?
- Conventional preventive work out and Gluteus maximus strengthening specific program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2022to 30 Apr 2022
- 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 12 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female basketball players belonging to a sports club.
- Female basketball players between 12 and 25 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Specific Strength Program of the Gluteus Maximus Muscle to Improve Dynamic Postural Control in Female Basketball Players
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.
Read more
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.
- Conditions
- Basketball
- Being tested
- Conventional preventive work out, Gluteus maximus strengthening specific program
- Keywords
- Dynamic Postural Control, Gluteus Maximus, Lower limb, Injury prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional preventive work outOther
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.
Gluteus maximus strengthening specific programOther
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.
- 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.
- 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.
- Quadruped hip extension with knee extension : Quadruped on forearms. Straighten the hip by bringing the whole leg up and back with knee extension.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group. Conventional preventive work out | Experimental | Not described Receives: Other: Conventional preventive work out |
| Intervention group. Gluteus maximus strengthening specific program | Experimental | Not described Receives: Other: Conventional preventive work out; Other: Gluteus maximus strengthening specific program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 months later
Secondary outcomes (5)
Change in the rate of lower limb injuries measured with a Daily Injury Report
Lower limb injuries occurrence will be recorded on a daily basis. For this purpose, one person in charge of each team, under the supervision of the researchers, will fill in an injury report. This report will include basic information about the injury, so as the location, the side of the body, the type and the mechanism of the injury and the time of injury, as well as the happening and duration of a sick leave.
Measured: Daily from baseline until the end of the research study 4 months later
Pain change measured with the Visual Analogue Scale
Players will be asked to rate from 0 to 10 their general pain and their specific pain in: ankle, knee, hip and low back.
Measured: Baseline and 4 months later
Vertical Jump Height using the app MyJump2
Vertical jump is calculated analysing it on a recorded video with the help of this app. It is necessary to select manually the take-off frame and landing frame. Videos will be recorded by the researchers in the frontal plane in the same position and distance from the jumping player. Participants will be taught to perform a correct vertical jump, starting from a static position with knees and hips at 90º and the hands on the hips, as well as stretching the knees during the flight and landing. The objective is to achieve the maximum height with the jump. Total leg length (from anterior iliac spine to tiptoe in maximum plantar flexion) and height with flexed knees at 90º (measured vertically from floor to greater trochanter) will be measured to calculate the height of vertical jumps with the help of the app.
Measured: Baseline and 4 months later
Dynamic knee valgus measured with the programme Kinovea
Players will be recorded from the frontal plane and in the same position for each player. Players shall perform three jumps in a row. Afterwards, with the Kinovea programme, the moment in which the highest knee valgus is produced in the landing of the different jumps will be analysed.
Measured: Baseline and 4 months later
Treatment adherence through an exercise tracking diary
Players will be required to fill in a sheet in which they will be requested for whether or not they have done the corresponding exercises during the week.
Measured: Weekly from baseline until the end of the research study 4 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start10 Jan 2022
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BasketballStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Achalandabaso, University of Jaén
- Investigators
- Sandra Sánchez, Principal investigator, University of Alcalá, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206786
- Sponsor's protocol ID
- CEIM/2021/6/130
- Status last verified
- May 2022
- First submitted
- 6 Jan 2022
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Specific Strength Program of the Gluteus Maximus Muscle to Improve Dynamic Postural Control in Female Basketball Players
- ClinicalTrials.gov ID
- NCT05206786
- Acronym / sponsor ID
- CEIM/2021/6/130
- Conditions
- Basketball
- Keywords
- Dynamic Postural Control, Gluteus Maximus, Lower limb, Injury prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 25 Jan 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group. Conventional preventive work out | Experimental | Other: Conventional preventive work out |
| Intervention group. Gluteus maximus strengthening specific program | Experimental | Other: Conventional preventive work out, Other: Gluteus maximus strengthening specific program |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Female basketball players belonging to a sports club.
- Female basketball players between 12 and 25 years old.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Conventional preventive work outFemale 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. | Other | Control group. Conventional preventive work out, Intervention group. Gluteus maximus strengthening specific program |
| Gluteus maximus strengthening specific programFemale 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. | Other | Intervention group. Gluteus maximus strengthening specific program |
Primary outcome
Dynamic stability change assessed by a modified version of the Star Excursion Balance Test (SEBT). For this, Octobo-Balance device will be used.
Time frame: Baseline and 4 months later
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.
5 secondary outcomes
Change in the rate of lower limb injuries measured with a Daily Injury Report
Time frame: Daily from baseline until the end of the research study 4 months later
Pain change measured with the Visual Analogue Scale
Time frame: Baseline and 4 months later
Vertical Jump Height using the app MyJump2
Time frame: Baseline and 4 months later
Dynamic knee valgus measured with the programme Kinovea
Time frame: Baseline and 4 months later
Treatment adherence through an exercise tracking diary
Time frame: Weekly from baseline until the end of the research study 4 months later
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 3 May 2022.
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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.
Sandra Sánchez principal investigator
University of Alcalá, Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional preventive work out and Gluteus maximus strengthening specific program in people with Basketball, run by University of Jaén 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 2 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 3 May 2022. 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?
Dynamic stability change assessed by a modified version of the Star Excursion Balance Test (SEBT). For this, Octobo-Balance device will be used. (time frame: Baseline and 4 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2022.