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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04697433
Other study ID # FIS190047
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 3, 2020
Est. completion date March 16, 2020

Study information

Verified date January 2021
Source São Paulo State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The clinical analysis of athletes has been performed in the sports field to obtain parameters for reliable evaluations. Among the tools used is the myotonometry, an analysis capable of quantitatively measuring tone, stiffness and elasticity. Its reliability has been tested in several populations, however, showing changes in results and presenting high variability in the confidence interval, also, the values of myotonometry differ according to sample specificity and the biomechanical properties of each muscle. Therefore, it seems pertinent to perform the reliability analysis in swimming athletes and verify their applicability and if the values of tone and muscular biomechanical properties vary according to the specificity of the modality. It will be a test and retest study composed of 50 young male and female swimming athletes, aged between 12 and 20 years. The evaluation of myotonometry will be performed randomly by two evaluators and the parameters measured will be: tone, stiffness, elasticity, relaxation time of mechanical stress and displacement. In the test stage, the first evaluator will perform the measurements bilaterally on the muscles and the second evaluator will perform the same measurements in the same order immediately after the first one. After 15 minutes, the retest will be performed following the same order of evaluators in the test. For characterization of sample will be used descriptive statistic through central tendency and variability for all variables collected. Relative reliability will be tested by the Intraclass Correlation Coefficient (ICC). Absolute reliability will be verified by means of standard error of measurement (SEM), values of least detectable change (MMD) and coefficient of variation (CV). The statistical package SPSS Statistics 22.0 will be used to conduct the reliability analyses.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date March 16, 2020
Est. primary completion date March 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 20 Years
Eligibility Inclusion Criteria: - Healthy swimming athletes Exclusion Criteria: - Being an alcoholic, consuming drugs, smoking or anti-inflammatory and / or analgesic drugs less than 24 hours before the test, presenting anemia, inflammatory process, diabetes, cardiovascular disease, episodes of muscle-tendon or osteoarticular injury in the lower, upper and / or lower limbs spine in the last three months, in addition to swimming for less than two years.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Myotonometry
The examiner should exert a slight pressure on the determined point to the necessary depth, which will be indicated by changing the color from red to green light on the device. The device has an automatically controlled preload (0.18 Newton (N)) that will be applied to the contact area by an automatic mechanical pulse, with a duration of 15 milliseconds (ms) and a constant force of 0.4 N , these oscillations will be registered by an accelerometer next to the measurement mechanism inside the device. For each evaluation, a series of 10 consecutive pulses (multiscan mode) will be used with an interval of one second between each pulse. In each shot, the tone, stiffness, elasticity, relaxation time and creep will be calculated.

Locations

Country Name City State
Brazil University of Sao Paulo State Presidente Prudente São Paulo

Sponsors (1)

Lead Sponsor Collaborator
São Paulo State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Tone MyotonPro (MyotonAS, Tallinn, Estonia), measured in Hertz (Hz) 75 minutes
Primary Stiffness MyotonPro (MyotonAS, Tallinn, Estônia), measured in Newton / meter (N/m) 75 minutes
Secondary Elasticity MyotonPro (MyotonAS, Tallinn, Estonia) 75 minutes
Secondary Mechanical Stress Relaxation Time MyotonPro (MyotonAS, Tallinn, Estonia), measured in milliseconds (ms) 75 minutes
Secondary Creep MyotonPro (MyotonAS, Tallinn, Estonia) 75 minutes
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