Football PlayersNCT04285593
Bulgarian Squat in the Improvement of Asymmetries of Lower Limbs in Soccer Players
A study testing Bulgarian squats in people with Football Players, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
1541/5000 The aim of the Bulgarian squat is to improve the hamstring strength and the stability of the knees, thus reducing asymmetries in the lower limbs. It consists in achieving greater strength and stability of the lower limbs to adapt the athlete to the demands of training and competitions as safely as possible. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Football Players
- What is being tested?
- Bulgarian squats
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2020to 10 Jun 2020
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female players
- With an age range of 18 to 35 years
- Federated in the Community of Madrid
- That at the time of the study do not suffer any injury
Who cannot join
- Athletes who have not undergone surgery on the lower limbs in the last three months
- Who have not taken muscle relaxants in the last three days
- Who have not understood or have a lack of understanding about the intervention
- Have not signed the informed consent document
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Bulgarian Squat in the Improvement of the Asymmetries of Lower Limbs Improving the Strength in the Hamstrings and Stability of the Knees in Soccer Players. A Randomized Clinical Study.
1541/5000 The aim of the Bulgarian squat is to improve the hamstring strength and the stability of the knees, thus reducing asymmetries in the lower limbs. It consists in achieving greater strength and stability of the lower limbs to adapt the athlete to the demands of training and competitions as safely as possible.
The main objective of the study is to assess the effectiveness of the Bulgarian squat, in the improvement of asymmetries in lower limbs; improving hamstring strength and knee stability.
Read more
Randomized, simple blind clinical study. 30 soccer players will be randomized to the study groups: experimental (Bulgarian squats) and control (non-intervention team routine). The treatment will last 4 weeks, with 2 weekly sessions of 10 minutes each. The study variables will be: lower limb strength (vertical jump with the My Jump 2 application), lower limb stability (Y ™ -Balance test) and lower limb asymmetries (Triple Hop Test, Single Hop Test for Distance and Functional Movement Screen) The normality of the sample will be calculated using the Kolmogorov -Smirnof test. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures, the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.
An improvement in the strength, stability and asymmetries of the lower limbs in soccer players is expected.
- Conditions
- Football Players
- Being tested
- Bulgarian squats
- Keywords
- Football, Knee, Bulgarian squat, Vertical jump, Functional movement screen, Hamstring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulgarian squatsOther
The intervention using Bulgarian squat exercises will consist in the application of the protocol described by Aguilera-Castells et al. The technique will be done with the footballer standing. The athlete with one foot in front and the other behind the body, arms crossed over her chest, and her upper body, will remain upright with a natural swing in the lower back during the entire exercise. The players will lower the body (eccentric phase) until the front knee flexes to 90º. Subsequently, they will return to the initial position with a full extension of the knee of the front leg (concentric phase), maintaining an erect trunk position. The front foot will be placed in a fixed position contacting the ground, and the rear foot will rest on a horizontal press bench.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Each session will last 10 minutes, taking place two days a week, over a period of four weeks. The intervention will take place at the beginning of the training session.
The players included in the experimental group will perform an exercise protocol with Bulgarian squats. Receives: Other: Bulgarian squats |
| Control group | No intervention | The players included in the control group will continue with their usual warm-up routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline hamstring muscle strength after treatment and at month
It will be done through the vertical jump Through the Appstore My Jump 2. The athlete will stand in standing position with the feet in parallel with a separation corresponding to the height of her hips. It will start with a knee flexion of 90º and with the arms along the body. You will be asked to perform a jump by bringing the lower limbs to a triple flexion (hip, knees and ankles). At the same time that it is pushed by pressing on the heels, it will take the arms in the take-off phase above its head. The load will be introduced if there is, in kg, and we will obtain the force time data (in Newton).
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (2)
Change from baseline stability after treatment and at month
It will be done with the Y-Balance test. The athletes will be placed in standing position in monopodal support with a slight knee flexion in the starting platform that consists of two rear pipes that will be placed at 135º from the previous pipe with 45º between the 2 back pipes. Barefoot athletes, with the support foot behind the red line of the central starting platform, will be asked to bring the leg that is not in support to the platforms located in the anterior and posterior tubes and slide them off continuous way and without bouncing as far as you can. Six trials will be performed on each leg in each of the three directions using the highest scores for analysis. The unit of measure of this instrument is centimeters: a higher score indicates greater stability, strength and proprioception.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline asymmetries of lower limbs after treatment and at month
With the Single Hop Test for Distance we will assess the ability of the player to make a maximum monopodal jump, measuring its distance in cm. A strip of tape 15 cm wide and 6 m long perpendicular to the starting line will be placed and the athlete will rest on one leg and with her foot on the line that marks the exit by performing a maximum horizontal jump, and receiving with the same leg The arms have to be throughout the hip test, not being able to use them to improve the jump. The distance will be measured from the starting line to the back of the heel. The athlete must maintain the position after the jump for at least 3 seconds without losing balance or supporting the other leg so that the repetition is counted. In case of not fulfilling said quality criteria in the execution, the jump will be repeated after the established recovery time.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start2 Mar 2020
- Primary completion20 May 2020
- Study completion10 Jun 2020
Why it stopped: COVID-19 Lockdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Football PlayersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285593
- Sponsor's protocol ID
- AJF
- Status last verified
- Sep 2021
- First submitted
- 25 Feb 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Bulgarian Squat in the Improvement of the Asymmetries of Lower Limbs Improving the Strength in the Hamstrings and Stability of the Knees in Soccer Players. A Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT04285593
- Acronym / sponsor ID
- AJF
- Conditions
- Football Players
- Keywords
- Football, Knee, Bulgarian squat, Vertical jump, Functional movement screen, Hamstring
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 Lockdown
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 26 Feb 2020 (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.
1541/5000 The aim of the Bulgarian squat is to improve the hamstring strength and the stability of the knees, thus reducing asymmetries in the lower limbs. It consists in achieving greater strength and stability of the lower limbs to adapt the athlete to the demands of training and competitions as safely as possible.
The main objective of the study is to assess the effectiveness of the Bulgarian squat, in the improvement of asymmetries in lower limbs; improving hamstring strength and knee stability.
Randomized, simple blind clinical study. 30 soccer players will be randomized to the study groups: experimental (Bulgarian squats) and control (non-intervention team routine). The treatment will last 4 weeks, with 2 weekly sessions of 10 minutes each. The study variables will be: lower limb strength (vertical jump with the My Jump 2 application), lower limb stability (Y ™ -Balance test) and lower limb asymmetries (Triple Hop Test, Single Hop Test for Distance and Functional Movement Screen) The normality of the sample will be calculated using the Kolmogorov -Smirnof test. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures, the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.
An improvement in the strength, stability and asymmetries of the lower limbs in soccer players is expected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Bulgarian squatsEach session will last 10 minutes, taking place two days a week, over a period of four weeks. The intervention will take place at the beginning of the training session. The players included in the experimental group will perform an exercise protocol with Bulgarian squats. |
| Control group | No intervention | –The players included in the control group will continue with their usual warm-up routine. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female players
- With an age range of 18 to 35 years
- Federated in the Community of Madrid
- That at the time of the study do not suffer any injury
Key exclusion criteria (4 listed)
- Athletes who have not undergone surgery on the lower limbs in the last three months
- Who have not taken muscle relaxants in the last three days
- Who have not understood or have a lack of understanding about the intervention
- Have not signed the informed consent document
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 |
|---|---|---|
| Bulgarian squatsThe intervention using Bulgarian squat exercises will consist in the application of the protocol described by Aguilera-Castells et al. The technique will be done with the footballer standing. The athlete with one foot in front and the other behind the body, arms crossed over her chest, and her upper body, will remain upright with a natural swing in the lower back during the entire exercise. The players will lower the body (eccentric phase) until the front knee flexes to 90º. Subsequently, they will return to the initial position with a full extension of the knee of the front leg (concentric phase), maintaining an erect trunk position. The front foot will be placed in a fixed position contacting the ground, and the rear foot will rest on a horizontal press bench. | Other | Experimental group |
Primary outcome
Change from baseline hamstring muscle strength after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
It will be done through the vertical jump Through the Appstore My Jump 2. The athlete will stand in standing position with the feet in parallel with a separation corresponding to the height of her hips. It will start with a knee flexion of 90º and with the arms along the body. You will be asked to perform a jump by bringing the lower limbs to a triple flexion (hip, knees and ankles). At the same time that it is pushed by pressing on the heels, it will take the arms in the take-off phase above its head. The load will be introduced if there is, in kg, and we will obtain the force time data (in Newton).
2 secondary outcomes
Change from baseline stability after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline asymmetries of lower limbs after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bulgarian squats in people with Football Players, run by Investigación en Hemofilia y Fisioterapia 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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 5 Sep 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline hamstring muscle strength after treatment and at month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). 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 5 Sep 2021.