HealthyNCT04139187

Biomechanics Responses to Power and Strength Combined Training

A study testing Combined training with power and strength exercises in people with Healthy, run by Universidade Federal de Santa Maria at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Combined training with power and strength exercises
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteBrazil
Study dates: 15 Sep 2019to Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

Body mass index greater than 35 kg/m².

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Karine Josibel Velasques Stoelben
Uruguaiana, Rio Grande do Sul, 97502-772

Other trials in Brazil

About this study

Official title: 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.

Read the 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
Being tested: Combined training with power and strength exercises
Keywords: Adult, Anterior Cruciate Ligament Injuries, Lower Extremity
Medical subject headings: Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combined training with power and strength exercisesOther
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).

Study groups in NCT04139187
Study group	Role	What they receive
Experimental	Experimental	Individuals randomized to experimental group. Receives: Other: Combined training with power and strength exercises
No Intervention Control	No intervention	Individuals without quadriceps dominance randomized to no intervention group.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline peak sagittal plane angle of ankle, knee and hip from both legs
Peak angle of sagittal plane during landing task
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and up to 10 weeks

Secondary outcomes (12)

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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Baseline and up to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 2019Dec 2020

First posted25 Oct 2019
Study start15 Sep 2019
Primary completionDec 2020 (estimated)
Study completionDec 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two groups design where one randomized group receive treatment and the other not in the same period of time.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 32 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04139187
Sponsor's protocol ID: 96793518.3.0000.5323
Status last verified: Jun 2020
First submitted: 4 Sep 2019
Last updated: 4 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lower Extremities Biomechanics Responses to Power and Strength Combined Training in Adults: a Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04139187
Acronym / sponsor ID: 96793518.3.0000.5323
Conditions: Healthy
Keywords: Adult, Anterior Cruciate Ligament Injuries, Lower Extremity
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 32 participants (estimated)
Lead sponsor: Universidade Federal de Santa MariaUniversity, hospital or other
Collaborators: Universidade Federal do Pampa, Conselho Nacional de Desenvolvimento Científico e Tecnológico
Study start: 15 Sep 2019 (actual)
Primary completion: Dec 2020 (estimated)
Study completion: Dec 2020 (estimated)
First posted: 25 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 outcomes will include functional clinical tests, kinematic and kinetic variables during landing tasks, and strength of knee and hip muscles.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: Two groups design where one randomized group receive treatment and the other not in the same period of time.

Arm	Type	Receives
Experimental	Experimental	Other: Combined training with power and strength exercisesIndividuals randomized to experimental group.
No Intervention Control	No intervention	–Individuals without quadriceps dominance randomized to no intervention group.

Who may qualify

Ages: 18 to 30 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (1 listed)

Body mass index greater than 35 kg/m².

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Combined training with power and strength exercisesThe 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).	Other	Experimental

Primary outcome

Change from baseline peak sagittal plane angle of ankle, knee and hip from both legs
Time frame: Baseline and up to 10 weeks
Peak angle of sagittal plane during landing task
Change from baseline value of sagittal plane angles for ankle, knee, hip, pelvis from both legs, and trunk
Time frame: Baseline and up to 10 weeks
Value at initial contact instant and maximal knee flexion instant of landing task
Change from baseline value of frontal plane angles for ankle, knee, hip, pelvis from both legs, and trunk
Time frame: Baseline and up to 10 weeks
Value at initial contact instant and maximal knee flexion instant of landing task
Change from baseline value of transverse plane angles for hip, pelvis from both legs, and trunk
Time frame: Baseline and up to 10 weeks
Value at initial contact instant and maximal knee flexion instant of landing task
Change from baseline peak frontal plane angle of knee and hip from both legs
Time frame: Baseline and up to 10 weeks
Peak angle of frontal plane during landing task
Change from baseline range of knee frontal plane angle from both legs
Time frame: Baseline and up to 10 weeks
Range of frontal plane angle between initial contact instant and maximal knee flexion instant of landing task
Change from baseline range of knee sagittal plane angle from both legs
Time frame: Baseline and up to 10 weeks
Range of sagittal plane angle between initial contact instant and maximal knee flexion instant of landing task
Change from baseline value of sagittal plane joint moment knee and hip from both legs
Time frame: Baseline and up to 10 weeks
Value at initial contact instant and maximal knee flexion instant of landing task
Change from baseline value of frontal plane joint moment knee and hip from both legs
Time frame: Baseline and up to 10 weeks
Value at initial contact instant and maximal knee flexion instant of landing task
Change from baseline peak of knee frontal plane joint moment from both legs
Time frame: Baseline and up to 10 weeks
Peak of joint moment during landing task
Change from baseline value of ground reaction force vertical component from both legs
Time frame: Baseline and up to 10 weeks
Value at maximal knee flexion instant of landing task
Change from baseline value of loading rate from both legs
Time frame: Baseline and up to 10 weeks
Value calculated by relation between peak of ground reaction force vertical component and time to peak from initial contact during landing task
Change from baseline peak of ground reaction force vertical component from both legs
Time frame: Baseline and up to 10 weeks
Peak of ground reaction force during landing task
Change from baseline value of muscle maximal isometric strength for knee extensors and flexors, and hip aductors and abductors from both legs
Time frame: Baseline and up to 10 weeks
Value of maximal isometric strength

12 secondary outcomes

Change from baseline pennation angle of muscle fibers of knee extensors and flexors from both legs
Time frame: Baseline and up to 10 weeks
Change from baseline muscle fascicle length of knee extensors and flexors from both legs
Time frame: Baseline and up to 10 weeks
Change from baseline muscle thickness of knee extensors and flexors from both legs
Time frame: Baseline and up to 10 weeks
Change from baseline power value of ankle, knee and hip joints from both legs
Time frame: Baseline and up to 10 weeks
Change from baseline dynamic strength of lower extremities muscles
Time frame: Baseline and up to 10 weeks
Change from baseline maximal dorsiflexion amplitude of ankle joint from both legs
Time frame: Baseline and up to 10 weeks
Change from baseline dynamic balance of lower extremities from both legs
Time frame: Baseline and up to 10 weeks
Change from baseline dynamic balance index of asymmetry between legs
Time frame: Baseline and up to 10 weeks
Change from baseline quality of dynamic movement of lower extremities from both legs
Time frame: Baseline and up to 10 weeks
Change from baseline asymmetry index of quality of dynamic movement between legs
Time frame: Baseline and up to 10 weeks
Change from baseline functional physical performance of lower extremities from both legs
Time frame: Baseline and up to 10 weeks
Change from baseline asymmetry index of functional physical performance between legs
Time frame: Baseline and up to 10 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Felipe P Carpes, PhD study director

Federal University of Pampa

Karine JV Stoelben, Ms principal investigator

Federal University of Pampa

Eliane C Guadagnin, PhD study chair

Federal University of Pampa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Combined training with power and strength exercises in people with Healthy, run by Universidade Federal de Santa Maria at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline peak sagittal plane angle of ankle, knee and hip from both legs (time frame: Baseline and up to 10 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04139187.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.