NCT04139187

Brief Summary

Anterior cruciate ligament (ACL) is the most frequently injured knee ligament during performance of recreational activities and sports. In the United States, the annual incidence is 68.6 per 100,000 people per year and in Brazil, the estimation of ACL reconstruction increases 64%. There are different biomechanical profiles of risk factors for an ACL injury variable, the ligament dominance, the quadriceps dominance, the trunk dominance, and the leg dominance. Thus, the purpose of this study is to investigate the biomechanics adaptations after power and strength combined training protocol in healthy individuals. A second aim is to determine the effect of the training on knee injury risk factors.

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
32

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

September 4, 2019

Last Update Submit

June 1, 2020

Conditions

Keywords

AdultAnterior Cruciate Ligament InjuriesLower Extremity

Outcome Measures

Primary Outcomes (14)

  • Change from baseline peak sagittal plane angle of ankle, knee and hip from both legs

    Peak angle of sagittal plane during landing task

    Baseline and up to 10 weeks

  • Change from baseline value of sagittal plane angles for ankle, knee, hip, pelvis from both legs, and trunk

    Value at initial contact instant and maximal knee flexion instant of landing task

    Baseline and up to 10 weeks

  • Change from baseline value of frontal plane angles for ankle, knee, hip, pelvis from both legs, and trunk

    Value at initial contact instant and maximal knee flexion instant of landing task

    Baseline and up to 10 weeks

  • Change from baseline value of transverse plane angles for hip, pelvis from both legs, and trunk

    Value at initial contact instant and maximal knee flexion instant of landing task

    Baseline and up to 10 weeks

  • Change from baseline peak frontal plane angle of knee and hip from both legs

    Peak angle of frontal plane during landing task

    Baseline and up to 10 weeks

  • Change from baseline range of knee frontal plane angle from both legs

    Range of frontal plane angle between initial contact instant and maximal knee flexion instant of landing task

    Baseline and up to 10 weeks

  • Change from baseline range of knee sagittal plane angle from both legs

    Range of sagittal plane angle between initial contact instant and maximal knee flexion instant of landing task

    Baseline and up to 10 weeks

  • Change from baseline value of sagittal plane joint moment knee and hip from both legs

    Value at initial contact instant and maximal knee flexion instant of landing task

    Baseline and up to 10 weeks

  • Change from baseline value of frontal plane joint moment knee and hip from both legs

    Value at initial contact instant and maximal knee flexion instant of landing task

    Baseline and up to 10 weeks

  • Change from baseline peak of knee frontal plane joint moment from both legs

    Peak of joint moment during landing task

    Baseline and up to 10 weeks

  • Change from baseline value of ground reaction force vertical component from both legs

    Value at maximal knee flexion instant of landing task

    Baseline and up to 10 weeks

  • Change from baseline value of loading rate from both legs

    Value calculated by relation between peak of ground reaction force vertical component and time to peak from initial contact during landing task

    Baseline and up to 10 weeks

  • Change from baseline peak of ground reaction force vertical component from both legs

    Peak of ground reaction force during landing task

    Baseline and up to 10 weeks

  • Change from baseline value of muscle maximal isometric strength for knee extensors and flexors, and hip aductors and abductors from both legs

    Value of maximal isometric strength

    Baseline and up to 10 weeks

Secondary Outcomes (12)

  • Change from baseline pennation angle of muscle fibers of knee extensors and flexors from both legs

    Baseline and up to 10 weeks

  • Change from baseline muscle fascicle length of knee extensors and flexors from both legs

    Baseline and up to 10 weeks

  • Change from baseline muscle thickness of knee extensors and flexors from both legs

    Baseline and up to 10 weeks

  • Change from baseline power value of ankle, knee and hip joints from both legs

    Baseline and up to 10 weeks

  • Change from baseline dynamic strength of lower extremities muscles

    Baseline and up to 10 weeks

  • +7 more secondary outcomes

Other Outcomes (2)

  • Training load of each training session

    At the end of each training session throughout 10 weeks

  • Muscle Soreness after each training session

    24 and 48 hours after each training session throughout 10 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Individuals randomized to experimental group.

Other: Combined training with power and strength exercises

No Intervention Control

NO INTERVENTION

Individuals without quadriceps dominance randomized to no intervention group.

Interventions

The training will be compose by power and strength exercises and divided in two days. One day with the exercises: vertical jumps, box jumps, sit-ups, back-extension and guided squat. The second with half squat jumps, high straight jumps, bounding jumps, drop jumps and sprint. Both days will be started with warm up on treadmill running lasting 5 minutes at 6.5-7.5 km/h. The training protocol includes 20 sessions with 2 sessions per week during 10 weeks (2 weeks to adaptation and others 8 to training with progression of load after 4 weeks).

Experimental

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male sex;
  • Age between 18 and 30 years old;
  • Who practice physical activity (except: strength and jump training) between 80 and 150 minute per week;
  • No previous muscle lower extremity injury at least 6 months prior to recruitment;
  • No previous ligament and tendon lower extremity injury or surgery;
  • No auditory, vestibular, visual or musculoskeletal injuries or disease that impairment the execution of assessments or training protocol;
  • No hypertension, cardiovascular or respiratory disease.

You may not qualify if:

  • Body mass index greater than 35 kg/m².

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karine Josibel Velasques Stoelben

Uruguaiana, Rio Grande do Sul, 97502-772, Brazil

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Felipe P Carpes, PhD

    Federal University of Pampa

    STUDY DIRECTOR
  • Karine JV Stoelben, Ms

    Federal University of Pampa

    PRINCIPAL INVESTIGATOR
  • Eliane C Guadagnin, PhD

    Federal University of Pampa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Statistical analyzer will be masking.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups design where one randomized group receive treatment and the other not in the same period of time.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2019

First Posted

October 25, 2019

Study Start

September 15, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

The investigators intend to publish the results in an open-access journal, indexed at the Directory of Open Access Journals, with the copyrights transferred to the authors. Details regarding the study's design and statistical plan can be obtained consulting the trial's protocol. Data on other outcomes could be requested contacting the PI.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
The individual participant dataset will become available at a public repository up to six months after the first study publication
Access Criteria
A simple registration will grant access to study datasets. The website for these files is not defined at the time of registration.

Locations