HealthyNCT04273971
Acute Effect of Plyometric Exercises on Musculotendinous Properties
A study testing Plyometric exercises in people with Healthy, run by Universidade Federal de Santa Maria at 1 site in Brazil.
Trial summary
Preventive and rehabilitation programs include plyometric exercises to promote agility, power, and muscle activation pattern during jumping. These exercises also are known to cause a high mechanical load that increases the risk of a musculoskeletal injury. Read more about this study
- 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?
- Plyometric exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Feb 2020to 30 Mar 2022
- 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
- Who practice physical activity (except jump training);
- No previous lower extremity muscle injury at least 6 months before the recruitment;
- No previous lower extremity ligament or tendon injury or surgery;
- No auditory, vestibular, visual or musculoskeletal injuries or disease that limit the execution of the exercise and assessment protocols;
- No hypertension, cardiovascular, or respiratory disease.
Who cannot join
- Body mass index greater than 30 kg/m².
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Karine Josibel Velasques Stoelben
Uruguaiana, Rio Grande do Sul, 97502772
About this study
Official title: Acute Effect of Plyometric Exercises on Musculotendinous Properties of Quadriceps and Biceps Femoral
Preventive and rehabilitation programs include plyometric exercises to promote agility, power, and muscle activation pattern during jumping. These exercises also are known to cause a high mechanical load that increases the risk of a musculoskeletal injury. The knowledge regarding the musculoskeletal damage result from this configuration of exercise can help to elaborate safer and effective training and rehabilitation programs. In this study, the investigators will conduct a clinical trial to determine the acute effect of plyometric exercises on damage caused on different portions of quadriceps and biceps femoral's muscles and tendons of quadriceps, and biceps femoral, and its effects on mechanical properties.
Read the detailed description
This is a single-arm clinical trial aiming to determine the acute effect of one session of plyometric exercises on quadriceps and biceps femoral musculotendinous properties in healthy individuals.
The sample size was determined using G*Power software considering the application of ANOVA: Repeated measures, between factors, 90% power, alpha 0.05. Data from muscle echo intensity of the rectus femoral by Muddle et al. (2019) were considered for this calculation, with an effect size 0.44. A total of 30 individuals was required for this study.
The outcomes will include the muscle and tendon quality, and mechanical properties of the tendon. The assessments will be performed at three different moments: before exercise, immediately after, and 48 hours after exercise.
The data analysis will be performed per protocol. Generalized estimating equations will be used to identify the effects of time followed by Bonferroni posthoc. When effects are found, effect sizes will be estimated. Missing data will be estimated by statistical analysis.
- Conditions
- Healthy
- Being tested
- Plyometric exercises
- Keywords
- Adult, Lower extermity, Plyometric exercise, Muscle properties
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plyometric exercisesOther
Plyometric exercises will be composed of vertical jumps, box jumps, half squat jumps, high straight jumps, bounding jumps, drop jumps and 10-m sprint.
| Study group | Role | What they receive |
|---|---|---|
| Plyometric exercise | Experimental | Not described Receives: Other: Plyometric exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of echo intensity of quadriceps and biceps femoral muscles
Muscle echo intensity will be assessed for transversal and longitudinal ultrasonography images.
Measured: Baseline, immediately after exercise and up to 48 hours exercise
Change from baseline stiffness of patellar tendon
Patellar tendon stiffness during 5 seconds rampa contraction protocol. Patellar tendon stiffness will be estimate from force/deformation relationship of tendon.
Measured: Baseline, immediately after exercise and up to 48 hours exercise
Change from baseline young modulus of patellar tendon
Patellar tendon young modulus during rampa contraction protocol. Young modulus will be estimate from force/deformation relationship of tendon normalized to transverse section area of tendon.
Measured: Baseline, immediately after exercise and up to 48 hours exercise
Secondary outcomes (1)
Change from baseline echo intensity of quadriceps and biceps femoral tendons
Tendons echo intensity will be assessed for transversal and longitudinal ultrasonography images.
Measured: Baseline, immediately after exercise and up to 48 hours exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start20 Feb 2020
- Primary completion5 Oct 2021 (estimated)
- Study completion30 Mar 2022 (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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm design where all participants receive treatment.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Rio Grande do Sul
- Responsible party
- Principal investigator, Karine Josibel Velasques Stoelben, Universidade Federal do Pampa
- Investigators
- Felipe P Carpes, PhD, Study director, Universidade Federal do PampaMarco A Vaz, PhD, Study chair, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273971
- Sponsor's protocol ID
- 20180702141429
- Status last verified
- Nov 2020
- First submitted
- 13 Feb 2020
- Last updated
- 5 Nov 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Plyometric Exercises on Musculotendinous Properties of Quadriceps and Biceps Femoral
- ClinicalTrials.gov ID
- NCT04273971
- Acronym / sponsor ID
- 20180702141429
- Conditions
- Healthy
- Keywords
- Adult, Lower extermity, Plyometric exercise, Muscle properties
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Rio Grande do Sul
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 5 Oct 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 18 Feb 2020 (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.
Preventive and rehabilitation programs include plyometric exercises to promote agility, power, and muscle activation pattern during jumping. These exercises also are known to cause a high mechanical load that increases the risk of a musculoskeletal injury. The knowledge regarding the musculoskeletal damage result from this configuration of exercise can help to elaborate safer and effective training and rehabilitation programs. In this study, the investigators will conduct a clinical trial to determine the acute effect of plyometric exercises on damage caused on different portions of quadriceps and biceps femoral's muscles and tendons of quadriceps, and biceps femoral, and its effects on mechanical properties.
Detailed description
This is a single-arm clinical trial aiming to determine the acute effect of one session of plyometric exercises on quadriceps and biceps femoral musculotendinous properties in healthy individuals.
The sample size was determined using G*Power software considering the application of ANOVA: Repeated measures, between factors, 90% power, alpha 0.05. Data from muscle echo intensity of the rectus femoral by Muddle et al. (2019) were considered for this calculation, with an effect size 0.44. A total of 30 individuals was required for this study.
The outcomes will include the muscle and tendon quality, and mechanical properties of the tendon. The assessments will be performed at three different moments: before exercise, immediately after, and 48 hours after exercise.
The data analysis will be performed per protocol. Generalized estimating equations will be used to identify the effects of time followed by Bonferroni posthoc. When effects are found, effect sizes will be estimated. Missing data will be estimated by statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm design where all participants receive treatment.
| Arm | Type | Receives |
|---|---|---|
| Plyometric exercise | Experimental | Other: Plyometric exercises |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Who practice physical activity (except jump training);
- No previous lower extremity muscle injury at least 6 months before the recruitment;
- No previous lower extremity ligament or tendon injury or surgery;
- No auditory, vestibular, visual or musculoskeletal injuries or disease that limit the execution of the exercise and assessment protocols;
- No hypertension, cardiovascular, or respiratory disease.
Key exclusion criteria (1 listed)
- Body mass index greater than 30 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 |
|---|---|---|
| Plyometric exercisesPlyometric exercises will be composed of vertical jumps, box jumps, half squat jumps, high straight jumps, bounding jumps, drop jumps and 10-m sprint. | Other | Plyometric exercise |
Primary outcome
Change from baseline of echo intensity of quadriceps and biceps femoral muscles
Time frame: Baseline, immediately after exercise and up to 48 hours exercise
Muscle echo intensity will be assessed for transversal and longitudinal ultrasonography images.
Change from baseline stiffness of patellar tendon
Time frame: Baseline, immediately after exercise and up to 48 hours exercise
Patellar tendon stiffness during 5 seconds rampa contraction protocol. Patellar tendon stiffness will be estimate from force/deformation relationship of tendon.
Change from baseline young modulus of patellar tendon
Time frame: Baseline, immediately after exercise and up to 48 hours exercise
Patellar tendon young modulus during rampa contraction protocol. Young modulus will be estimate from force/deformation relationship of tendon normalized to transverse section area of tendon.
1 secondary outcome
Change from baseline echo intensity of quadriceps and biceps femoral tendons
Time frame: Baseline, immediately after exercise and up to 48 hours exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 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
Universidade Federal do Pampa
Marco A Vaz, PhD study chair
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plyometric 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 5 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 5 Nov 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 of echo intensity of quadriceps and biceps femoral muscles (time frame: Baseline, immediately after exercise and up to 48 hours exercise). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2020.