An interventional study of Combined training with power and strength exercises in Healthy, sponsored by Universidade Federal de Santa Maria. Status unknown at 1 site in Brazil. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by Universidade Federal de Santa Maria · Not applicable, Interventional, and Treatment
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.
Universidade Federal de Santa Maria is the lead sponsor of 36 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Individuals randomized to experimental group.
Other: Combined training with power and strength exercises
Individuals without quadriceps dominance randomized to no intervention group.
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).
Change from baseline peak sagittal plane angle of ankle, knee and hip from both legs
Peak angle of sagittal plane during landing task
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and up to 10 weeks
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.
Time frame: Baseline and up to 10 weeks
Change from baseline muscle fascicle length of knee extensors and flexors from both legs
The distance between the intersection composed of the superficial aponeurosis and fascicle and the intersection composed of the deep aponeurosis and the fascicle
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: Baseline and up to 10 weeks
Training load of each training session
Product between rate of perceived exertion and session duration training
Time frame: At the end of each training session throughout 10 weeks
Muscle Soreness after each training session
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
Time frame: 24 and 48 hours after each training session throughout 10 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
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Universidade Federal de Santa Maria