Anterior Cruciate Ligament InjuriesNCT04690127
Muscle Architecture and Anterior Cruciate Ligament
A study testing Plyometric Exercise in people with Anterior Cruciate Ligament Injuries, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effects of plyometric training on biceps femoris longus (BFl) and vastus lateralis (VL) muscle architecture in individuals with anterior cruciate ligament reconstruction (ACLR). Individuals will be randomly placed into training and control groups. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Plyometric Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 1 Aug 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers with unilateral anterior cruciate ligament reconstruction (ACLR)
- Volunteers using hamstring autograft in their ACLR
- Volunteers who have passed 1-5 years after their ACLR
Who cannot join
- Those who underwent same-side meniscus repair other than ACLR
- Those who have had revision surgery
- Those who had posterior cruciate ligament rupture in addition to anterior cruciate ligament
- Third-degree tears in the lateral or medial collateral ligaments
- Those with 2nd or 3rd degree strain injuries in hamstring and quadriceps muscle groups
- Those with a history of congenital, neurological, orthopedic, rheumatologic and cardiopulmonary pathology or anomalies,
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- Those with serious systemic diseases
- Relative Exclusion Criteria:
- Those with acute infection or pain
- Those with joint instability
- Those with a body mass index of 30 and above
- Those receiving energy supplements or ergogenic assistance during or during the 6-month period prior to work
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe Üniversitesi
Ankara, Türkiye, 06230
Murat Emirzeoğlu, +90 4623778842, muratemirzeoglu@gmail.com
Özlem Ülger
About this study
Official title: The Effects of Plyometric Training on Vastus Lateralis and Biceps Femoris Muscle Architectures in Individuals Undergoing Anterior Cruciate Ligament Reconstruction
The aim of this study is to examine the effects of plyometric training on biceps femoris longus (BFl) and vastus lateralis (VL) muscle architecture in individuals with anterior cruciate ligament reconstruction (ACLR). Individuals will be randomly placed into training and control groups. Measurements of muscle architecture will be taken bilaterally from BFl and VL muscles by means of an ultrasound device. Functional performance will be evaluated with the International Knee Documentation Committee score and the single leg jump test. Following the initial evaluations, individuals in the training group will receive plyometric training. Evaluations of muscle architecture and functional performance will be taken again from the individuals in the training and control groups at the end of the 4th and 8th weeks. The received ultrasound images will be calculated through the MicroDicom software. In-group and between-group comparisons will be analyzed using the Statistical Package for the Social Sciences program and appropriate tests.
Read the detailed description
Anterior cruciate ligament (ACL) injuries are common, especially in young individuals participating in rolling and jumping activities. After injury, many people undergo ACL reconstruction (ACLR) surgery. The aim of this study is to examine the effects of plyometric training on biceps femoris longus (BFl) and vastus lateralis (VL) muscle architecture (fiber length, penation angle and muscle thickness) in individuals with ACLR. Individuals who have undergone ACLR in this study, which is designed as a parallel group randomized controlled study, will be randomly placed into two different groups, the training group and the control group. Imagery ability, self-efficacy and motivation will be evaluated with various questionnaires and scales in order to compare the homogeneity of the groups. Measurements of muscle architecture will be taken bilaterally from BFl and VL muscles by means of an ultrasound device. Functional performance will be evaluated with the International Knee Documentation Committee score and the single leg jump test. Following the initial evaluations, individuals in the training group will receive plyometric training consisting of ten different exercises for 8 weeks, 3 sessions per week. In this training, individuals will not participate in a real plyometric training. Volunteers will watch videos to be prepared (action observation) and imagine them performing those exercises (motor imagery). Except for one session that will be applied every two weeks, all other trainings will be given on the basis of telerehabilitation via distance education tools. Cognitive fatigue at the beginning and end of the session; at the end of each session, the technical quality and efficiency of the training will be evaluated. Evaluations of muscle architecture and functional performance will be taken again from the individuals in the control and training groups at the end of the 4th and 8th weeks. The received ultrasound images will be calculated through the MicroDicom software. In-group and between-group comparisons will be analyzed using the Statistical Package for the Social Sciences program and appropriate tests.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Plyometric Exercise
- Keywords
- biceps femoris, vastus lateralis, muscle architecture, anterior cruciate ligament, plyometric training, action observation, motor imagery, fiber length, pennation angle, muscle thickness, function
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plyometric ExerciseOther
Plyometric training consisting of ten different exercises [vertical unilateral and bilateral counter movement jump, horizontal unilateral and bilateral counter movement jump, drop jump (30 cm), squat jump, step-hop (20 cm), 180 degree rotation in transverse plane, frontal plane hurdle jump (20 cm) and sagittal plane hurdle jump (20 cm)] for 8 weeks, 3 sessions per week. Individuals will not participate in a real plyometric training. Volunteers will watch videos to be prepared (action observation) and imagine them performing those exercises (motor imagery)
| Study group | Role | What they receive |
|---|---|---|
| Plyometric Training Group | Experimental | Individuals in the plyometric training group will receive plyometric training. In this training, individuals will not participate in a real plyometric training. Volunteers will watch videos to be prepared (action observation) and imagine them performing those exercises (motor imagery). Except for one session that will be applied every two weeks, all other trainings will be given on the basis of telerehabilitation via distance education tools. Receives: Other: Plyometric Exercise |
| Control Group | No intervention | Volunteers in this group will not participate in any training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Architecture Change-1
Fiber length of the vastus lateralis and biceps femoris longus muscles
Measured: Before, at the end of the fourth week and the eighth week
Muscle Architecture Change-2
Pennation angle of the vastus lateralis and biceps femoris longus muscles
Measured: Before, at the end of the fourth week and the eighth week
Muscle Architecture Change-3
Muscle thickness of the vastus lateralis and biceps femoris longus muscles
Measured: Before, at the end of the fourth week and the eighth week
Secondary outcomes (2)
Functional Performance Change-1
International knee documentation committee score. (Minimum score: 0 Maximum score: 100. Higher scores mean a better outcome.
Measured: Before, at the end of the fourth week and the eighth week
Functional Performance Change-2
Single leg jump distance
Measured: Before, at the end of the fourth week and the eighth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Feb 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Model description
- Parallel group randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat EMİRZEOĞLU, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690127
- Sponsor's protocol ID
- 2020-11167
- Status last verified
- Sep 2022
- First submitted
- 19 Dec 2020
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Plyometric Training on Vastus Lateralis and Biceps Femoris Muscle Architectures in Individuals Undergoing Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04690127
- Acronym / sponsor ID
- 2020-11167
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- biceps femoris, vastus lateralis, muscle architecture, anterior cruciate ligament, plyometric training, action observation, motor imagery, fiber length
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 30 Dec 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.
The aim of this study is to examine the effects of plyometric training on biceps femoris longus (BFl) and vastus lateralis (VL) muscle architecture in individuals with anterior cruciate ligament reconstruction (ACLR). Individuals will be randomly placed into training and control groups. Measurements of muscle architecture will be taken bilaterally from BFl and VL muscles by means of an ultrasound device. Functional performance will be evaluated with the International Knee Documentation Committee score and the single leg jump test. Following the initial evaluations, individuals in the training group will receive plyometric training. Evaluations of muscle architecture and functional performance will be taken again from the individuals in the training and control groups at the end of the 4th and 8th weeks. The received ultrasound images will be calculated through the MicroDicom software. In-group and between-group comparisons will be analyzed using the Statistical Package for the Social Sciences program and appropriate tests.
Detailed description
Anterior cruciate ligament (ACL) injuries are common, especially in young individuals participating in rolling and jumping activities. After injury, many people undergo ACL reconstruction (ACLR) surgery. The aim of this study is to examine the effects of plyometric training on biceps femoris longus (BFl) and vastus lateralis (VL) muscle architecture (fiber length, penation angle and muscle thickness) in individuals with ACLR. Individuals who have undergone ACLR in this study, which is designed as a parallel group randomized controlled study, will be randomly placed into two different groups, the training group and the control group. Imagery ability, self-efficacy and motivation will be evaluated with various questionnaires and scales in order to compare the homogeneity of the groups. Measurements of muscle architecture will be taken bilaterally from BFl and VL muscles by means of an ultrasound device. Functional performance will be evaluated with the International Knee Documentation Committee score and the single leg jump test. Following the initial evaluations, individuals in the training group will receive plyometric training consisting of ten different exercises for 8 weeks, 3 sessions per week. In this training, individuals will not participate in a real plyometric training. Volunteers will watch videos to be prepared (action observation) and imagine them performing those exercises (motor imagery). Except for one session that will be applied every two weeks, all other trainings will be given on the basis of telerehabilitation via distance education tools. Cognitive fatigue at the beginning and end of the session; at the end of each session, the technical quality and efficiency of the training will be evaluated. Evaluations of muscle architecture and functional performance will be taken again from the individuals in the control and training groups at the end of the 4th and 8th weeks. The received ultrasound images will be calculated through the MicroDicom software. In-group and between-group comparisons will be analyzed using the Statistical Package for the Social Sciences program and appropriate tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Plyometric Training Group | Experimental | Other: Plyometric ExerciseIndividuals in the plyometric training group will receive plyometric training. In this training, individuals will not participate in a real plyometric training. Volunteers will watch videos to be prepared (action observation) and imagine them performing those exercises (motor imagery). Except for one session that will be applied every two weeks, all other trainings will be given on the basis of telerehabilitation via distance education tools. |
| Control Group | No intervention | –Volunteers in this group will not participate in any training. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Volunteers with unilateral anterior cruciate ligament reconstruction (ACLR)
- Volunteers using hamstring autograft in their ACLR
- Volunteers who have passed 1-5 years after their ACLR
Key exclusion criteria (12 listed)
- Those who underwent same-side meniscus repair other than ACLR
- Those who have had revision surgery
- Those who had posterior cruciate ligament rupture in addition to anterior cruciate ligament
- Third-degree tears in the lateral or medial collateral ligaments
- Those with 2nd or 3rd degree strain injuries in hamstring and quadriceps muscle groups
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 |
|---|---|---|
| Plyometric ExercisePlyometric training consisting of ten different exercises [vertical unilateral and bilateral counter movement jump, horizontal unilateral and bilateral counter movement jump, drop jump (30 cm), squat jump, step-hop (20 cm), 180 degree rotation in transverse plane, frontal plane hurdle jump (20 cm) and sagittal plane hurdle jump (20 cm)] for 8 weeks, 3 sessions per week. Individuals will not participate in a real plyometric training. Volunteers will watch videos to be prepared (action observation) and imagine them performing those exercises (motor imagery) | Other | Plyometric Training Group |
Primary outcome
Muscle Architecture Change-1
Time frame: Before, at the end of the fourth week and the eighth week
Fiber length of the vastus lateralis and biceps femoris longus muscles
Muscle Architecture Change-2
Time frame: Before, at the end of the fourth week and the eighth week
Pennation angle of the vastus lateralis and biceps femoris longus muscles
Muscle Architecture Change-3
Time frame: Before, at the end of the fourth week and the eighth week
Muscle thickness of the vastus lateralis and biceps femoris longus muscles
2 secondary outcomes
Functional Performance Change-1
Time frame: Before, at the end of the fourth week and the eighth week
Functional Performance Change-2
Time frame: Before, at the end of the fourth week and the eighth week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plyometric Exercise in people with Anterior Cruciate Ligament Injuries, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 12 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: status not confirmed, as of the sponsor's last update on 26 Sep 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Murat Emirzeoğlu (+904623778842, muratemirzeoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Architecture Change-1 (time frame: Before, at the end of the fourth week and the eighth week). 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 26 Sep 2022.