HealthyNCT06053632
Young Age Soccer Player's Lower Limb Muscle Imbalance and Functional Status
A study testing Low-load and high-velocity - lying prone - eccentric hamstring exercise in people with Healthy, run by Lithuanian Sports University at 1 site in Lithuania.
Trial summary
A randomized controlled trial is designed to examine the effects of low-load and high-velocity eccentric exercises on lower limb muscular properties, imbalances and functional status of 13-15 years old female football players. Read more about this study
- Who is it for?
- Ages 13 to 15 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Low-load and high-velocity - lying prone - eccentric hamstring exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Mar 2023to 30 May 2023
- 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 13 to 15 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy players able to participate in training and competitions.
- Playing football for at least 2 years.
- Regularly participating in team training, 2-3 times a week.
Who cannot join
- Female soccer players with a lower extremity injury (in a period of 6 months)
- Pain is less than 2 points on the Visual Analog Pain Scale.
- Irregular exercise
- The number of years of training attended is too low
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Eccentric Exercises on Lower Limb Muscle Imbalances and Functional Status of Young Female Football Players
A randomized controlled trial is designed to examine the effects of low-load and high-velocity eccentric exercises on lower limb muscular properties, imbalances and functional status of 13-15 years old female football players.
Read the detailed description
Twenty participants were included in the study. All participants were divided in two groups - control and experimental. In the experimental group (n=10) participants after team soccer training additional received 4 weeks eccentric exercises, in the control group (n=10) - did not perform additional exercises. The research group performed additional low-load and high-velocity - lying prone - eccentric hamstring exercise 3 times per week for 4 weeks. Pre- and post- training assessment included concentric/eccentric knee extension and flexion at 60°/s and 120°/s, changes in muscle contractile characteristics and dynamic balance.
- Conditions
- Healthy
- Being tested
- Low-load and high-velocity - lying prone - eccentric hamstring exercise
- Keywords
- Young age soccer player, Eccentric hamstring exercise, Dynamic balance, Contractile muscle properties
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-load and high-velocity - lying prone - eccentric hamstring exerciseBehavioural
Low-load and high-velocity - lying prone - eccentric hamstring exercise 3 times per week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group will be asked to maintain their usual lifestyle. |
| Experimental group | Experimental | The research group performed additional low-load and high-velocity - lying prone - eccentric hamstring exercise 3 times per week for 4 weeks. 12 sessions in total. Receives: Behavioral: Low-load and high-velocity - lying prone - eccentric hamstring exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in isokinetic peak torque (with Biodex)
Knee extension/flexion isokinetic peak torque measurements will be done at 60°/s, 120°/s
Measured: Baseline and after 4 weeks
Dynamic balance
Y-balance Test evaluates lower extremity strength, knee stability and dynamic balance in anterior, posteromedial and posterolateral direction. For each direction, three practice trials were allowed before three test trials were recorded. Mean reach distances (cm) was normalized to leg length, which was measured from the anterior superior iliac spine to the most distal portion of the medial malleolus.
Measured: Baseline and after 4 weeks
Changes in muscle contractile characteristics (with tensiomyography (TMG))
Muscle involuntary contractile characteristics of the lower-limb muscles-the rectus femoris (RF), vastus medialis (VM), vastus lateralis (VL), biceps femoris (BF), semitendinosus (ST), tibialis anterior (TA), gastrocnemius medialis (GM) and gastrocnemius lateralis (GL)-will be recorded by measuring the response of these muscles to an induced electric stimulus (provoked by two self-adhesive electrodes) using TMG equipment on both the left and right lower extremities.
Measured: Baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Mar 2023
- Primary completion1 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dovile Kiele, PhD, Principal investigator, Lithuanian Sports University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053632
- Sponsor's protocol ID
- LithuananianSportsU-15
- Status last verified
- Sep 2023
- First submitted
- 19 Sep 2023
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eccentric Exercises on Lower Limb Muscle Imbalances and Functional Status of Young Female Football Players
- ClinicalTrials.gov ID
- NCT06053632
- Acronym / sponsor ID
- LithuananianSportsU-15
- Conditions
- Healthy
- Keywords
- Young age soccer player, Eccentric hamstring exercise, Dynamic balance, Contractile muscle properties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 26 Sep 2023 (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.
A randomized controlled trial is designed to examine the effects of low-load and high-velocity eccentric exercises on lower limb muscular properties, imbalances and functional status of 13-15 years old female football players.
Detailed description
Twenty participants were included in the study. All participants were divided in two groups - control and experimental. In the experimental group (n=10) participants after team soccer training additional received 4 weeks eccentric exercises, in the control group (n=10) - did not perform additional exercises. The research group performed additional low-load and high-velocity - lying prone - eccentric hamstring exercise 3 times per week for 4 weeks. Pre- and post- training assessment included concentric/eccentric knee extension and flexion at 60°/s and 120°/s, changes in muscle contractile characteristics and dynamic balance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group will be asked to maintain their usual lifestyle. |
| Experimental group | Experimental | Behavioral: Low-load and high-velocity - lying prone - eccentric hamstring exerciseThe research group performed additional low-load and high-velocity - lying prone - eccentric hamstring exercise 3 times per week for 4 weeks. 12 sessions in total. |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy players able to participate in training and competitions.
- Playing football for at least 2 years.
- Regularly participating in team training, 2-3 times a week.
Key exclusion criteria (4 listed)
- Female soccer players with a lower extremity injury (in a period of 6 months)
- Pain is less than 2 points on the Visual Analog Pain Scale.
- Irregular exercise
- The number of years of training attended is too low
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 |
|---|---|---|
| Low-load and high-velocity - lying prone - eccentric hamstring exerciseLow-load and high-velocity - lying prone - eccentric hamstring exercise 3 times per week for 4 weeks. | Behavioural | Experimental group |
Primary outcome
Changes in isokinetic peak torque (with Biodex)
Time frame: Baseline and after 4 weeks
Knee extension/flexion isokinetic peak torque measurements will be done at 60°/s, 120°/s
Dynamic balance
Time frame: Baseline and after 4 weeks
Y-balance Test evaluates lower extremity strength, knee stability and dynamic balance in anterior, posteromedial and posterolateral direction. For each direction, three practice trials were allowed before three test trials were recorded. Mean reach distances (cm) was normalized to leg length, which was measured from the anterior superior iliac spine to the most distal portion of the medial malleolus.
Changes in muscle contractile characteristics (with tensiomyography (TMG))
Time frame: Baseline and after 4 weeks
Muscle involuntary contractile characteristics of the lower-limb muscles-the rectus femoris (RF), vastus medialis (VM), vastus lateralis (VL), biceps femoris (BF), semitendinosus (ST), tibialis anterior (TA), gastrocnemius medialis (GM) and gastrocnemius lateralis (GL)-will be recorded by measuring the response of these muscles to an induced electric stimulus (provoked by two self-adhesive electrodes) using TMG equipment on both the left and right lower extremities.
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 28 Sep 2023.
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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.
Dovile Kiele, PhD principal investigator
Lithuanian Sports University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-load and high-velocity - lying prone - eccentric hamstring exercise in people with Healthy, run by Lithuanian Sports University at 1 site in Lithuania.
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 3 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: finished, as of the sponsor's last update on 28 Sep 2023. 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 Lithuania. 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?
Changes in isokinetic peak torque (with Biodex) (time frame: Baseline and after 4 weeks). The study lists 3 primary outcomes in all. 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 28 Sep 2023.