Biomechanics Responses to Power and Strength Combined Training

Lower Extremities Biomechanics Responses to Power and Strength Combined Training in Adults: a Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Other: Combined training with power and strength exercises

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Uruguaiana, Rio Grande Do Sul, Brazil, 97502-772
      • Karine Josibel Velasques Stoelben

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Body mass index greater than 35 kg/m².

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Individuals randomized to experimental group.	Other: Combined training with power and strength exercises; 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).
No Intervention: No Intervention Control; Individuals without quadriceps dominance randomized to no intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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 Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Universidade Federal de Santa Maria
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Universidade Federal do Pampa
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): September 15, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Anterior Cruciate Ligament Injuries; Adult; Lower Extremity
• Other Study ID Numbers: 96793518.3.0000.5323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The individual participant dataset will become available at a public repository up to six months after the first study publication
• IPD Sharing Access Criteria: A simple registration will grant access to study datasets. The website for these files is not defined at the time of registration.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No