Clinical trial NCT04139187: Biomechanics Responses to Power and Strength Combined Training
Official title: Lower Extremities Biomechanics Responses to Power and Strength Combined Training in Adults: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Adult
Anterior Cruciate Ligament Injuries
Lower Extremity
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Pampa
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2019-10-25
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups design where one randomized group receive treatment and the other not in the same period of time.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline peak sagittal plane angle of ankle, knee and hip from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline value of sagittal plane angles for ankle, knee, hip, pelvis from both legs, and trunk
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline value of frontal plane angles for ankle, knee, hip, pelvis from both legs, and trunk
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline value of transverse plane angles for hip, pelvis from both legs, and trunk
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline peak frontal plane angle of knee and hip from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline range of knee frontal plane angle from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline range of knee sagittal plane angle from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline value of sagittal plane joint moment knee and hip from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline value of frontal plane joint moment knee and hip from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline peak of knee frontal plane joint moment from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline value of ground reaction force vertical component from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline value of loading rate from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline peak of ground reaction force vertical component from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline value of muscle maximal isometric strength for knee extensors and flexors, and hip aductors and abductors from both legs
timeFrame: Baseline and up to 10 weeks
Secondary outcomes:
measure: Change from baseline pennation angle of muscle fibers of knee extensors and flexors from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline muscle fascicle length of knee extensors and flexors from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline muscle thickness of knee extensors and flexors from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline power value of ankle, knee and hip joints from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline dynamic strength of lower extremities muscles
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline maximal dorsiflexion amplitude of ankle joint from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline dynamic balance of lower extremities from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline dynamic balance index of asymmetry between legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline quality of dynamic movement of lower extremities from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline asymmetry index of quality of dynamic movement between legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline functional physical performance of lower extremities from both legs
timeFrame: Baseline and up to 10 weeks
measure: Change from baseline asymmetry index of functional physical performance between legs
timeFrame: Baseline and up to 10 weeks
Other outcomes:
measure: Training load of each training session
timeFrame: At the end of each training session throughout 10 weeks
measure: Muscle Soreness after each training session
timeFrame: 24 and 48 hours after each training session throughout 10 weeks
Locations:
city: Uruguaiana
country: Brazil
facility: Karine Josibel Velasques Stoelben
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Pampa
name: Felipe P Carpes, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of Pampa
name: Karine JV Stoelben, Ms
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Pampa
name: Eliane C Guadagnin, PhD
role: STUDY_CHAIR
References: