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| Name | Class |
|---|---|
| Universidade Federal do Pampa | OTHER |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
This is a parallel randomized clinical trial comparing the effect of combined training with power and strength exercises on lower extremity biomechanics in healthy individuals.
The sample size was calculated with G*Power software using the ANOVA: Repeated measures, within-between interaction, 90% power, alpha 0.05, and 30% drop-out. Data from the tuck jump test (knee flexion range) by Makaruk (2014) were considered for this calculation with effect size 0.46. Thus, a total of 32 individuals (16 per group) is required for this study. To ensure the proper simple size, after collecting the first five participants per group, the sample size will be checked again.
The participants will be randomized in experimental and no intervention groups inside each risk profile group. Randomization ratio will be 1:1 and interventions will last 10 weeks, with two weekly sessions for the exercise arms.
The outcomes will include functional clinical tests, kinematic and kinetic variables during landing tasks, and strength of knee and hip muscles.
The data analysis will be performed by intention to treat and per protocol. Generalized estimating equations will be used to identify interaction effects of groups and time followed by Bonferroni post-hoc. When effect are found, effect size will be estimated. Missing data will be estimate by statistical analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Individuals randomized to experimental group. |
|
| No Intervention Control | No Intervention | Individuals without quadriceps dominance randomized to no intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined training with power and strength exercises | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline pennation angle of muscle fibers of knee extensors and flexors from both legs | The angle between the longitudinal axis of the entire muscle and its fibers. | Baseline and up to 10 weeks |
| Change from baseline muscle fascicle length of knee extensors and flexors from both legs |
| Measure | Description | Time Frame |
|---|---|---|
| Training load of each training session | Product between rate of perceived exertion and session duration training | At the end of each training session throughout 10 weeks |
| Muscle Soreness after each training session |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karine Josibel Velasques Stoelben | Uruguaiana | Rio Grande do Sul | 97502-772 | Brazil |
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.
The individual participant dataset will become available at a public repository up to six months after the first study publication
A simple registration will grant access to study datasets. The website for these files is not defined at the time of registration.
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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Two groups design where one randomized group receive treatment and the other not in the same period of time.
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Statistical analyzer will be masking.
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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 |
The distance between the intersection composed of the superficial aponeurosis and fascicle and the intersection composed of the deep aponeurosis and the fascicle |
| Baseline and up to 10 weeks |
| Change from baseline muscle thickness of knee extensors and flexors from both legs | Estimation of muscle cross-sectional area | Baseline and up to 10 weeks |
| Change from baseline power value of ankle, knee and hip joints from both legs | Relation of work and velocity during landing task | Baseline and up to 10 weeks |
| Change from baseline dynamic strength of lower extremities muscles | The force developed to perform one maximal repetition to perform leg press and squat tasks | Baseline and up to 10 weeks |
| Change from baseline maximal dorsiflexion amplitude of ankle joint from both legs | Maximal dorsiflexion amplitude obtained during lunge test | Baseline and up to 10 weeks |
| Change from baseline dynamic balance of lower extremities from both legs | Dynamic balance is assessed according the displacement obtained during Star Excursion Balance Test | Baseline and up to 10 weeks |
| Change from baseline dynamic balance index of asymmetry between legs | Dynamic balance is assessed according the displacement obtained during Star Excursion Balance Test. The asymmetry index is calculated by relation between preferred and non preferred legs. | Baseline and up to 10 weeks |
| Change from baseline quality of dynamic movement of lower extremities from both legs | Quality of movement is assessed according the escore obtained during Lateral Step Down test performance | Baseline and up to 10 weeks |
| Change from baseline asymmetry index of quality of dynamic movement between legs | Quality of movement is assessed according the escore obtained during Lateral Step Down test performance. The asymmetry index is calculated by relation between preferred and non preferred legs. | Baseline and up to 10 weeks |
| Change from baseline functional physical performance of lower extremities from both legs | Assessed according the maximal distance obtained during hop tests performance (single, triple and crossover) | Baseline and up to 10 weeks |
| Change from baseline asymmetry index of functional physical performance between legs | Assessed according the maximal distance obtained during hop tests performance (single, triple and crossover). The asymmetry index is calculated by relation between preferred and non preferred legs. | Baseline and up to 10 weeks |
Value from visual analog scale (score between 0 to 10 points) representative to discomfort or pain after training sessions. Higher values represent worst discomfor/pain
| 24 and 48 hours after each training session throughout 10 weeks |