Female AthleteNCT04255290
Plyometric and Eccentric Training in Improving the Strength, Stability and Ability of Women Soccer Players
A study testing Leg Squat Lounge in people with Female Athlete, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction. The high rate of recurrence and clinical involvement of muscle injuries in lower limbs, makes the hamstring musculature a very important structure in the development of athletes. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Athlete
- What is being tested?
- Leg Squat Lounge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2020to 10 May 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- 18 to 30 years old
- With 3 or less days of training a week
- Federate in the Community of Madrid (Spain)
Who cannot join
- Players who are injured and cannot do the job at the time of the study
- Soccer players who have had a hamstring injury in the last 6 months
- To practice another sport
- They are receiving physiotherapy treatment in the lower limb
- Not signing the informed consent document
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Plyometric and Eccentric Training in Improving the Strength, Stability and Ability of Women Soccer Players. A Randomized Pilot Study.
Introduction. The high rate of recurrence and clinical involvement of muscle injuries in lower limbs, makes the hamstring musculature a very important structure in the development of athletes. Excentric movements, where eccentric force and flexibility are fundamental, and the quadriceps-hamstrings contraction cycle are risk factors for hamstring muscle injury.
Aim. ascertain the effectiveness of plyometric and excéntric exercises in the improvement of hamstring strength.
Read more
Study design. Randomized, prospective, multicenter, single-blind clinical study with athletes.
Methods. This study will be carried out with a sample of 40 women, federated players from 18 to 30 years old. They will be randomized into two groups: experimental (plyometric work and eccentric exercises) and control (eccentric exercises). The intervention will last 6 weeks in which, before each training, they will carry out the intervention, for 20 minutes, 3 days a week. An inter-judges piloting will be carried out. We will analyze the normality of the sample with the Kolmogorov-smirnov test and for the inferential analysis, we will use the t-student test of paired data to observe the difference between each evaluation in each study group, and the repeated measures ANOVA to calculate the effect intra and intergroup. Using Cohen's formula we will calculate the size of the effect.
Expected results. The eccentric work along with the plyometrics improves strength in hamstrings, jumping and stability.
- Conditions
- Female Athlete
- Being tested
- Leg Squat Lounge, Control group
- Keywords
- Isquiotibial, Plyometrics, Eccentric, Soccer, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg Squat LoungeOther
The players assigned to the experimental group will receive an intervention through plyometric and eccentric hamstring exercises
Control groupOther
The subjects included in the control group will perform an eccentric work protocol
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Leg Squat Lounge: The player will be placed in squat position and her partner will be placed behind, suspending the most posterior leg in the air. With the leg that is supported, you will perform a monopodal jump with controlled fall, supporting the foot from tip to heel. It will be done with both lower limbs performing 1 series of 5 repetitions with 30 seconds of rest between sets. 180 jump: The footballer will start in bipodal support, with the trunk erect and hands on the hips. Perform a bipodal jump with a 180º turn during this, keeping the fall for 2 seconds. Each repetition, the turn will be done in a different sense. It will carry out 2 series of 20 sec of execution with 20 sec of rest between series. Brad jump stick landing: The player will stand in hands-free standing. Perform a bipodal jump as far as possible. The knees will not exceed the tip of the foot and the fall will be with a trunk position as straight as possible. He will make 5 jumps the first two weeks. Receives: Other: Leg Squat Lounge |
| Control group | Active comparator | Nordic Funds: One player will stand on her knees, while the other, behind, fixes her legs. The kneeling footballer must drop forward in a controlled manner until she touches the ground and returns to the starting position. The Diver: Player in monopodal support on the lower limb to work, performing hip flexion with the arms forward and the opposite lower limb back, looking for a horizontality in the pelvis (with 10º-20º knee flexion) It will be done with both lower limbs.
The Glider: With the footballer standing in front of her partner, holding both of them by the shoulders, she lets one leg slide back while the other stays fixed. To return to the starting position, it will be helped by the other player, while the knee will not exceed 10 degrees of flexion. The distribution of all the exercises will be: 2 sets of 5 repetitions with 20 sec rest between sets Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline hamstring strength after treatment and at 1 month
The mobile application "Nordic" will be used to assess the strength of the hamstring muscles. With the athlete kneeling on the floor, fixed by a partner from the ankles, she will drop down forward. The evaluator will be on the side, recording with a smartphone (Iphone 7) to measure the moment when the subject uncrosses the arms. The test will be carried out up to three times, taking the measures of the angle of rupture in the exercise (angle that forms the trunk with the ground considering the position of the tibiae). The unit of measure the breaking angle.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (2)
Change from baseline the jump after treatment and at 1 month
With the mobile application "My jump 2.0" the jump will be measured. The athlete will be located 1.5 meters from the evaluator, who will be in front of her with a mobile (iPhone 7 model) at ground level. The test will consist of the realization of a Counter Movement Jump (CMJ). The unit of measure of the jump of the application will be the Newton.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline lower limb stability after treatment and at 1 month
With the Y-Balance test the lower limb stability will be measured. The player will be placed in the center of an inverted Y-shaped figure, and in monopodal support on the leg to be evaluated. 3 attempts will be made for each of the scopes (anterior, posteromedial and posterolateral). The distance will be measured in centimeters, taking as value the arithmetic mean of the three attempts made in each range. The Y-shaped figure will be made with tape on the floor. The distance calculation will be carried out with a tape measure.
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 posted5 Feb 2020
- Study start10 Feb 2020
- Primary completion30 Apr 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female AthleteStudies 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
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255290
- Sponsor's protocol ID
- HAM-EXPL
- Status last verified
- Sep 2021
- First submitted
- 1 Feb 2020
- Last updated
- 2 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 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Plyometric and Eccentric Training in Improving the Strength, Stability and Ability of Women Soccer Players. A Randomized Pilot Study.
- ClinicalTrials.gov ID
- NCT04255290
- Acronym / sponsor ID
- HAM-EXPL
- Conditions
- Female Athlete
- Keywords
- Isquiotibial, Plyometrics, Eccentric, Soccer, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 5 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.
Introduction. The high rate of recurrence and clinical involvement of muscle injuries in lower limbs, makes the hamstring musculature a very important structure in the development of athletes. Excentric movements, where eccentric force and flexibility are fundamental, and the quadriceps-hamstrings contraction cycle are risk factors for hamstring muscle injury.
Aim. ascertain the effectiveness of plyometric and excéntric exercises in the improvement of hamstring strength.
Study design. Randomized, prospective, multicenter, single-blind clinical study with athletes.
Methods. This study will be carried out with a sample of 40 women, federated players from 18 to 30 years old. They will be randomized into two groups: experimental (plyometric work and eccentric exercises) and control (eccentric exercises). The intervention will last 6 weeks in which, before each training, they will carry out the intervention, for 20 minutes, 3 days a week. An inter-judges piloting will be carried out. We will analyze the normality of the sample with the Kolmogorov-smirnov test and for the inferential analysis, we will use the t-student test of paired data to observe the difference between each evaluation in each study group, and the repeated measures ANOVA to calculate the effect intra and intergroup. Using Cohen's formula we will calculate the size of the effect.
Expected results. The eccentric work along with the plyometrics improves strength in hamstrings, jumping and stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Leg Squat LoungeLeg Squat Lounge: The player will be placed in squat position and her partner will be placed behind, suspending the most posterior leg in the air. With the leg that is supported, you will perform a monopodal jump with controlled fall, supporting the foot from tip to heel. It will be done with both lower limbs performing 1 series of 5 repetitions with 30 seconds of rest between sets. 180 jump: The footballer will start in bipodal support, with the trunk erect and hands on the hips. Perform a bipodal jump with a 180º turn during this, keeping the fall for 2 seconds. Each repetition, the turn will be done in a different sense. It will carry out 2 series of 20 sec of execution with 20 sec of rest between series. Brad jump stick landing: The player will stand in hands-free standing. Perform a bipodal jump as far as possible. The knees will not exceed the tip of the foot and the fall will be with a trunk position as straight as possible. He will make 5 jumps the first two weeks. |
| Control group | Active comparator | Other: Control groupNordic Funds: One player will stand on her knees, while the other, behind, fixes her legs. The kneeling footballer must drop forward in a controlled manner until she touches the ground and returns to the starting position. The Diver: Player in monopodal support on the lower limb to work, performing hip flexion with the arms forward and the opposite lower limb back, looking for a horizontality in the pelvis (with 10º-20º knee flexion) It will be done with both lower limbs. The Glider: With the footballer standing in front of her partner, holding both of them by the shoulders, she lets one leg slide back while the other stays fixed. To return to the starting position, it will be helped by the other player, while the knee will not exceed 10 degrees of flexion. The distribution of all the exercises will be: 2 sets of 5 repetitions with 20 sec rest between sets |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women
- 18 to 30 years old
- With 3 or less days of training a week
- Federate in the Community of Madrid (Spain)
Key exclusion criteria (5 listed)
- Players who are injured and cannot do the job at the time of the study
- Soccer players who have had a hamstring injury in the last 6 months
- To practice another sport
- They are receiving physiotherapy treatment in the lower limb
- Not signing 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 |
|---|---|---|
| Leg Squat LoungeThe players assigned to the experimental group will receive an intervention through plyometric and eccentric hamstring exercises | Other | Experimental group |
| Control groupThe subjects included in the control group will perform an eccentric work protocol | Other | Control group |
Primary outcome
Change from baseline hamstring strength after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
The mobile application "Nordic" will be used to assess the strength of the hamstring muscles. With the athlete kneeling on the floor, fixed by a partner from the ankles, she will drop down forward. The evaluator will be on the side, recording with a smartphone (Iphone 7) to measure the moment when the subject uncrosses the arms. The test will be carried out up to three times, taking the measures of the angle of rupture in the exercise (angle that forms the trunk with the ground considering the position of the tibiae). The unit of measure the breaking angle.
2 secondary outcomes
Change from baseline the jump after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline lower limb stability after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
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 2 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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leg Squat Lounge in people with Female Athlete, 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 5 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 2 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 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?
Change from baseline hamstring strength after treatment and at 1 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 2 Sep 2021.