Biomechanics Responses to Power and Strength Combined Training

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04139187
• Other study ID #: 96793518.3.0000.5323
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: Universidade Federal de Santa Maria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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).

Locations

Country	Name	City	State
Brazil	Karine Josibel Velasques Stoelben	Uruguaiana	Rio Grande Do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Universidade Federal do Pampa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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