NCT04690127

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

2.2 years

First QC Date

December 19, 2020

Last Update Submit

September 23, 2022

Conditions

Keywords

biceps femorisvastus lateralismuscle architectureanterior cruciate ligamentplyometric trainingaction observationmotor imageryfiber lengthpennation anglemuscle thicknessfunction

Outcome Measures

Primary Outcomes (3)

  • Muscle Architecture Change-1

    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

    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

    Muscle thickness of the vastus lateralis and biceps femoris longus muscles

    Before, at the end of the fourth week and the eighth week

Secondary Outcomes (2)

  • Functional Performance Change-1

    Before, at the end of the fourth week and the eighth week

  • Functional Performance Change-2

    Before, at the end of the fourth week and the eighth week

Study Arms (2)

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.

Other: Plyometric Exercise

Control Group

NO INTERVENTION

Volunteers in this group will not participate in any training.

Interventions

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)

Plyometric Training Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe Üniversitesi

Ankara, Türkiye, 06230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel group randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist (MSc)

Study Record Dates

First Submitted

December 19, 2020

First Posted

December 30, 2020

Study Start

February 1, 2021

Primary Completion

April 1, 2023

Study Completion

August 1, 2023

Last Updated

September 26, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations