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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04273971
Other study ID # 20180702141429
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 20, 2020
Est. completion date March 30, 2022

Study information

Verified date November 2020
Source Universidade Federal de Santa Maria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date March 30, 2022
Est. primary completion date October 5, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Body mass index greater than 30 kg/m².

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Plyometric exercises
Plyometric exercises will be composed of vertical jumps, box jumps, half squat jumps, high straight jumps, bounding jumps, drop jumps and 10-m sprint.

Locations

Country Name City State
Brazil Karine Josibel Velasques Stoelben Uruguaiana RS

Sponsors (3)

Lead Sponsor Collaborator
Universidade Federal de Santa Maria Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline muscle soreness of quadriceps and biceps femoral muscles Soreness will be measure as treashold of pain feeling while a hand-held dynamometer apply force. Baseline and up to 48 hours exercise
Primary Change from baseline of echo intensity of quadriceps and biceps femoral muscles Muscle echo intensity will be assessed for transversal and longitudinal ultrasonography images. Baseline, immediately after exercise and up to 48 hours exercise
Primary 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. Baseline, immediately after exercise and up to 48 hours exercise
Primary 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. Baseline, immediately after exercise and up to 48 hours exercise
Secondary Change from baseline echo intensity of quadriceps and biceps femoral tendons Tendons echo intensity will be assessed for transversal and longitudinal ultrasonography images. Baseline, immediately after exercise and up to 48 hours exercise
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