Biomechanics Responses to Power and Strength Combined Training
Lower Extremities Biomechanics Responses to Power and Strength Combined Training in Adults: a Randomized Clinical Trial
1 other identifier
interventional
32
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Sep 2019
Typical duration for not_applicable healthy
1 active site
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
September 4, 2019
CompletedStudy Start
First participant enrolled
September 15, 2019
CompletedFirst Posted
Study publicly available on registry
October 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJune 4, 2020
June 1, 2020
1.2 years
September 4, 2019
June 1, 2020
Conditions
Keywords
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
EXPERIMENTALIndividuals randomized to experimental group.
No Intervention Control
NO INTERVENTIONIndividuals 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).
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Felipe P Carpes, PhD
Federal University of Pampa
- PRINCIPAL INVESTIGATOR
Karine JV Stoelben, Ms
Federal University of Pampa
- STUDY CHAIR
Eliane C Guadagnin, PhD
Federal University of Pampa
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
- 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
- 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.
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.