Muscle LossNCT03872076
Plyometric Exercises Versus Isometric Exercises With Theraband Elastic Band in Water Polo Players
A study testing Experimental in people with Muscle Loss, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction: The improvement of strength affects muscle volume, dynamic stability and sports performance in water polo athletes. Plyometric exercises can improve biomechanics, performance and the most explosive actions during sports. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Loss
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2019to 20 Jun 2019
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Swimmers with more than 2 years of sports practice
- Age range of 18 to 25 years
- Currently participate in national championships.
Who cannot join
- Have some type of musculoskeletal injuries at the time of the study
- Not signed the informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Protocol of Plyometric Exercises in the Improvement of Quadriceps Muscle Strength Versus Isometric Exercises With Theraband Elastic Band in Federated Water Polo Players. A Randomized Pilot Study.
Introduction: The improvement of strength affects muscle volume, dynamic stability and sports performance in water polo athletes. Plyometric exercises can improve biomechanics, performance and the most explosive actions during sports. The work done with elastic bands will increase the effectiveness and the resistance on the isometric exercises developed.
Objectives: To evaluate the effectiveness of plyometric exercises in the increase of quadriceps muscle strength, volume and stability dynamic in female athletic of water polo players from 18 to 25 years old.
Read more
Study Design: A randomized, multicentric, single-blind clinical study with a follow-up period.
Methodology: 25 water polo players will be recruited and randomly assigned to the two study groups: experimental (plyometric exercises plus isometric exercises with elastic bands) and control (isometric exercises with elastic bands). The intervention will last for 8 weeks, with 3 weekly sessions, of 15 minutes each. The study variables will be: strength (measured with the RM test), muscle volume (using anthropometry), and dynamic stability (through the SEBT test). The analysis of normality will be carried out with the Shapiro Wilk test. In case of homogeneity of the groups, we will use parametric tests: t-student test of repeated measures (difference between evaluations) and ANOVA of repeated means (intra and intersubject effect).
Expected Results: It is expected to observe improvement in muscle strength and quadriceps volume, as well as dynamic stability.
- Conditions
- Muscle Loss
- Being tested
- Experimental, Control
- Keywords
- Strengthening, Stability, Muscle Volume, Physical Effort, Randomized clinical trial
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Also called Plyometric exercises
The Drom Jump technique with the legs flexed will be performed with the patient standing in front of a bench 30 cm high by 100 cm wide. The physiotherapist will be placed lateral to the athlete. The subject will be asked to jump up from the box or bench, with the hip and knees in semi-reflexion, with his hands on his hip and he will be asked for an explosive jump, followed by a jump downwards falling the floor of the same way.
The technique of lateral jumps on cones will be carried out by means of unipodal jumps, achieving a distance of 50 cm between cones. The physiotherapist will stand in front of the athlete. The subject will be asked to perform a lateral unipodal explosive jump by flexing the hip and knee.
ControlOther
Also called Isometric exercises
Elastic bands will be combined with isometric exercises in 3 sets of 10 repetitions each. The exercises they will perform are front squat. On the one hand, separating the legs at the height of the shoulders with hip and knee flexion, with the elastic band above the knees, maintaining the position 20 seconds.
In the following exercise, with the elastic band on the ankle, in unipodal support at the same time that the contralateral limb is free of support, the hip will be flexed at 45º with full knee extension, requesting the athlete to keep the tension 20 seconds, performing 3 sets of 10 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Plyometric exercises | Experimental | The subjects included in the experimental group will carry out an intervention using plyometric exercises and isometric exercises with elastic band for the quadriceps muscle. Each session will last 15 minutes, taking place for 3 days a week, in a period of 8 weeks. The intervention will be made at the beginning of the training session. Receives: Other: Experimental |
| Isometric exercises | Active comparator | The subjects included in the experimental group will carry out an intervention of isometric exercises with elastic bands for the quadriceps muscle. Each session will last 8 minutes, taking place for 3 days a week, in a period of 8 weeks. The intervention will be made at the beginning of the training session. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline maximum strength in quadriceps after treatment and at month
Researchers will use the 1RM test to measure maximum strength by trial and error, taking into account the nRM (number of repetitions) performing a repetition for each series without exceeding 15 maximum repetitions, or even be effective in less than 10 maximum repetitions increasing the load in each series progressively, depending on the abilities of the athletes. We will perform 5 minutes of light activities, then one minute of stretching, heating of eight repetitions to 50% of 1RM, followed by three repetitions at 70% of 1RM. After 5 minutes of the interval, the 1RM test will be performed. The weight will increase progressively 5kg, three to five times until the maximum RM. The assessment of quadriceps muscle strength will be assessed through the full squat exercise. The unit of measurement is the Kg, indicating a greater amount of Kg, a greater maximum force in quadriceps
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (2)
Change from baseline muscle volume in quadriceps after treatment and at month
A metric tape will be used as a measuring instrument to assess muscle volume of quadriceps. Once the segment to be assessed is identified, we will make the assessment with the athlete in standing position. A mark will be made on the upper edge of the patella, and another one at 10 centimeters in the same plane of movement, in caudal-cranial direction. The evaluation will be carried out by measuring the entire contour on the marked lines, thus defining the different perimeters. This test has the centimeter (cm) as the unit of measurement. The higher the score, the more muscle volume the subject reflects in the valued segment.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline dynamic stability after treatment and at month
The evaluation of the dynamic stability will be carried out through the use of the Star Excursion Balance Test. With the patient in a standing position, squatting on a limb without support will be requested. On the ground, 8 lines will be marked with a separation between them of 45 degrees forming a star. Data will be obtained in different planes (anterior, anterolateral, medial, posteromedial, posterolateral and posterior). The athlete must establish a stable base at the point of support and keep it in all directions, while trying to touch the lines with the most distal part of the foot and return to the starting position. This scale has the centimeter as a unit of measurement: the higher the score in centimeters, the more dynamic stability the athlete presents.
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 posted12 Mar 2019
- Study start12 Mar 2019
- Primary completion15 May 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle LossStudies 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
- 25 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
- NCT03872076
- Sponsor's protocol ID
- WATPLIO
- Status last verified
- Jan 2020
- First submitted
- 10 Mar 2019
- Last updated
- 27 Jan 2020
- 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Protocol of Plyometric Exercises in the Improvement of Quadriceps Muscle Strength Versus Isometric Exercises With Theraband Elastic Band in Federated Water Polo Players. A Randomized Pilot Study.
- ClinicalTrials.gov ID
- NCT03872076
- Acronym / sponsor ID
- WATPLIO
- Conditions
- Muscle Loss
- Keywords
- Strengthening, Stability, Muscle Volume, Physical Effort, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 12 Mar 2019 (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 improvement of strength affects muscle volume, dynamic stability and sports performance in water polo athletes. Plyometric exercises can improve biomechanics, performance and the most explosive actions during sports. The work done with elastic bands will increase the effectiveness and the resistance on the isometric exercises developed.
Objectives: To evaluate the effectiveness of plyometric exercises in the increase of quadriceps muscle strength, volume and stability dynamic in female athletic of water polo players from 18 to 25 years old.
Study Design: A randomized, multicentric, single-blind clinical study with a follow-up period.
Methodology: 25 water polo players will be recruited and randomly assigned to the two study groups: experimental (plyometric exercises plus isometric exercises with elastic bands) and control (isometric exercises with elastic bands). The intervention will last for 8 weeks, with 3 weekly sessions, of 15 minutes each. The study variables will be: strength (measured with the RM test), muscle volume (using anthropometry), and dynamic stability (through the SEBT test). The analysis of normality will be carried out with the Shapiro Wilk test. In case of homogeneity of the groups, we will use parametric tests: t-student test of repeated measures (difference between evaluations) and ANOVA of repeated means (intra and intersubject effect).
Expected Results: It is expected to observe improvement in muscle strength and quadriceps volume, as well as dynamic stability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plyometric exercises | Experimental | Other: ExperimentalThe subjects included in the experimental group will carry out an intervention using plyometric exercises and isometric exercises with elastic band for the quadriceps muscle. Each session will last 15 minutes, taking place for 3 days a week, in a period of 8 weeks. The intervention will be made at the beginning of the training session. |
| Isometric exercises | Active comparator | Other: ControlThe subjects included in the experimental group will carry out an intervention of isometric exercises with elastic bands for the quadriceps muscle. Each session will last 8 minutes, taking place for 3 days a week, in a period of 8 weeks. The intervention will be made at the beginning of the training session. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female
- Swimmers with more than 2 years of sports practice
- Age range of 18 to 25 years
- Currently participate in national championships.
Key exclusion criteria (2 listed)
- Have some type of musculoskeletal injuries at the time of the study
- 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 |
|---|---|---|
| ExperimentalAlso: Plyometric exercisesThe Drom Jump technique with the legs flexed will be performed with the patient standing in front of a bench 30 cm high by 100 cm wide. The physiotherapist will be placed lateral to the athlete. The subject will be asked to jump up from the box or bench, with the hip and knees in semi-reflexion, with his hands on his hip and he will be asked for an explosive jump, followed by a jump downwards falling the floor of the same way. The technique of lateral jumps on cones will be carried out by means of unipodal jumps, achieving a distance of 50 cm between cones. The physiotherapist will stand in front of the athlete. The subject will be asked to perform a lateral unipodal explosive jump by flexing the hip and knee. | Other | Plyometric exercises |
| ControlAlso: Isometric exercisesElastic bands will be combined with isometric exercises in 3 sets of 10 repetitions each. The exercises they will perform are front squat. On the one hand, separating the legs at the height of the shoulders with hip and knee flexion, with the elastic band above the knees, maintaining the position 20 seconds. In the following exercise, with the elastic band on the ankle, in unipodal support at the same time that the contralateral limb is free of support, the hip will be flexed at 45º with full knee extension, requesting the athlete to keep the tension 20 seconds, performing 3 sets of 10 repetitions. | Other | Isometric exercises |
Primary outcome
Change from baseline maximum strength in quadriceps after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Researchers will use the 1RM test to measure maximum strength by trial and error, taking into account the nRM (number of repetitions) performing a repetition for each series without exceeding 15 maximum repetitions, or even be effective in less than 10 maximum repetitions increasing the load in each series progressively, depending on the abilities of the athletes. We will perform 5 minutes of light activities, then one minute of stretching, heating of eight repetitions to 50% of 1RM, followed by three repetitions at 70% of 1RM. After 5 minutes of the interval, the 1RM test will be performed. The weight will increase progressively 5kg, three to five times until the maximum RM. The assessment of quadriceps muscle strength will be assessed through the full squat exercise. The unit of measurement is the Kg, indicating a greater amount of Kg, a greater maximum force in quadriceps
2 secondary outcomes
Change from baseline muscle volume in quadriceps 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 dynamic stability 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 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 27 Jan 2020.
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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 Experimental in people with Muscle Loss, 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 2 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 27 Jan 2020. 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 maximum strength in quadriceps 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 27 Jan 2020.