NCT01433718

Brief Summary

Anterior cruciate ligament (ACL) tears are disabling injuries that place a significant burden on the athlete. Roughly 80% of these injuries are linked to a noncontact mechanism, with more than 70% of them occurring while landing from a jump. Female athletes are at higher risk of sustaining a noncontact ACL injury due to the higher number of risk factors that they possess compared to their male counterparts. Due to this statistic, ACL prevention programs have been developed over the past 15 years in attempt to reduce this risk among the female athletic population. These programs have been shown to reduce the rate of noncontact ACL injuries in females by correcting the risk factors associated with them. However, it remains unclear as to whether these positive results are solely due to the program or a higher exercise workload in its participants. The purpose of this study is to evaluate the effectiveness that an ACL prevention program has on modifying at-risk landing mechanics (associated with noncontact ACL injury) compared to a resistance training program of equal workload.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

September 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

September 9, 2011

Last Update Submit

April 19, 2017

Conditions

Keywords

EffectivnessNeuromuscular TrainingResistance TrainingModificationAnterior Cruciate Ligament Risk FactorsDrop-JumpKnee SeparationResistance training program

Outcome Measures

Primary Outcomes (1)

  • Change in Knee separation during the Drop Jump Test

    Participants will begin the test by standing on a box, dropping off, landing straight in front of the box, and immediately performing a maximum vertical jump. Following the completion of the three trials, the examiner chooses the trial in which the participant has the highest jump to best represent the participant's jumping ability for video analysis. The following images will be captured as still photographs: (1) pre-landing; (2) land; and (3) takeoff.

    1 week prior to training begins, and 1 week after training finishes.

Secondary Outcomes (1)

  • Changes in Vertical Jump Test

    1 week prior to training begins, and 1 week after training finishes

Study Arms (1)

ACL prevention training

EXPERIMENTAL
Procedure: Neuromuscular and Resistance Training

Interventions

1 hour/session, 3 sessions/week, 6 weeks

ACL prevention training

Eligibility Criteria

Age18 Years - 20 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female college underclassman (ages 18-20)
  • Body Mass Index (BM) between 18.5 - 25 (normal range)
  • Blood pressure below 140/90 (below hypertension)
  • History of participation in high school athletics
  • Signed Informed Consent form

You may not qualify if:

  • History of ACL injury
  • Current/ongoing knee condition
  • History of surgical intervention within one year (not including facial)
  • Current/ongoing musculoskeletal injury
  • History of previous ACL prevention training
  • Currently involved in intercollegiate athletics
  • Currently Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Resistance Training

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

Study Officials

  • Conrad M Gabler, B.S.

    Graduate Athletic Training Student

    PRINCIPAL INVESTIGATOR
  • Brian G Ragan, Ph.D.

    Athletic Training Program Assistant Professor and Research Coordinator

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 14, 2011

Study Start

September 1, 2011

Primary Completion

February 1, 2012

Study Completion

June 1, 2012

Last Updated

April 21, 2017

Record last verified: 2017-04

Locations