Muscle Architecture and Anterior Cruciate Ligament

September 23, 2022 updated by: Murat EMİRZEOĞLU, Hacettepe University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Türkiye
      • Ankara, Türkiye, Turkey, 06230
        • Recruiting
        • Hacettepe Universitesi
        • Contact:
        • Principal Investigator:
          • Özlem Ülger

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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,
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Plyometric Training Group
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.
Other: Plyometric Exercise
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)
No Intervention: Control Group
Volunteers in this group will not participate in any training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Before, at the end of the fourth week and the eighth week
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
Before, at the end of the fourth week and the eighth week
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
Before, at the end of the fourth week and the eighth week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Performance Change-1
Time Frame: Before, at the end of the fourth week and the eighth week
International knee documentation committee score. (Minimum score: 0 Maximum score: 100. Higher scores mean a better outcome.
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
Single leg jump distance
Before, at the end of the fourth week and the eighth week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-11167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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