Biomechanics Responses to Power and Strength Combined Training

NCT ID: NCT04139187

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-15
• Study Completion Date: 2020-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental

Individuals randomized to experimental group.

Group Type: EXPERIMENTAL

Combined training with power and strength exercises

Intervention Type: 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).

No Intervention Control

Individuals without quadriceps dominance randomized to no intervention group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Pampa

OTHER

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Universidade Federal de Santa Maria

OTHER

Sponsor Role: lead

Responsible Party

Karine Josibel Velasques Stoelben

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe P Carpes, PhD

Role: STUDY_DIRECTOR

Federal University of Pampa

Karine JV Stoelben, Ms

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pampa

Eliane C Guadagnin, PhD

Role: STUDY_CHAIR

Federal University of Pampa

Locations

Karine Josibel Velasques Stoelben

Uruguaiana, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

96793518.3.0000.5323

Identifier Type: -

Identifier Source: org_study_id