AthletesNCT04697433
Reliability of Myotonometry in Swimming Athletes
An observational study of Athletes, run by São Paulo State University at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletes
- What is being tested?
- Myotonometry
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Feb 2020to 16 Mar 2020
- Phase
- Observational
- 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 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Young swimming athletes who regularly train and are members of the swimming teams of the 4th region of the state of São Paulo, of the São Paulo Aquatic Federation (FAP), of the cities of Presidente Prudente, Votuporanga and São José do Rio Preto.
Who may be able to join
- Healthy swimming athletes
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo State
Presidente Prudente, São Paulo, 19060-900
About this study
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.
- Conditions
- Athletes
- Being tested
- Myotonometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyotonometryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Myotonometry | The evaluation of myotonometry will be carried out by two independent evaluators. The first evaluator will perform the test bilaterally on the middle deltoid, upper trapezius, pectoralis major, biceps brachii, rectus femoris, anterior tibialis, triceps brachii, lumbar multifidus, biceps femoris and soleus previously marked. Immediately after, the second appraiser will perform the same measurements in the same order (Inter-rater reliability). After a 15-minute interval, the retest (intra-rater reliability) will be performed following the same procedure and order as the test step. Receives: Device: Myotonometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Tone
MyotonPro (MyotonAS, Tallinn, Estonia), measured in Hertz (Hz)
Measured: 75 minutes
Stiffness
MyotonPro (MyotonAS, Tallinn, Estônia), measured in Newton / meter (N/m)
Measured: 75 minutes
Secondary outcomes (3)
Elasticity
MyotonPro (MyotonAS, Tallinn, Estonia)
Measured: 75 minutes
Mechanical Stress Relaxation Time
MyotonPro (MyotonAS, Tallinn, Estonia), measured in milliseconds (ms)
Measured: 75 minutes
Creep
MyotonPro (MyotonAS, Tallinn, Estonia)
Measured: 75 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start3 Feb 2020
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthletesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697433
- Sponsor's protocol ID
- FIS190047
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be disclosed, because as participants are under eighteen
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Myotonometry in Swimming Athletes
- ClinicalTrials.gov ID
- NCT04697433
- Acronym / sponsor ID
- FIS190047
- Conditions
- Athletes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 6 Jan 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myotonometry | – | Device: MyotonometryThe evaluation of myotonometry will be carried out by two independent evaluators. The first evaluator will perform the test bilaterally on the middle deltoid, upper trapezius, pectoralis major, biceps brachii, rectus femoris, anterior tibialis, triceps brachii, lumbar multifidus, biceps femoris and soleus previously marked. Immediately after, the second appraiser will perform the same measurements in the same order (Inter-rater reliability). After a 15-minute interval, the retest (intra-rater reliability) will be performed following the same procedure and order as the test step. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Young swimming athletes who regularly train and are members of the swimming teams of the 4th region of the state of São Paulo, of the São Paulo Aquatic Federation (FAP), of the cities of Presidente Prudente, Votuporanga and São José do Rio Preto.
Key inclusion criteria (1 listed)
- Healthy swimming athletes
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| MyotonometryThe 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. | Device | Myotonometry |
Primary outcome
Muscle Tone
Time frame: 75 minutes
MyotonPro (MyotonAS, Tallinn, Estonia), measured in Hertz (Hz)
Stiffness
Time frame: 75 minutes
MyotonPro (MyotonAS, Tallinn, Estônia), measured in Newton / meter (N/m)
3 secondary outcomes
Elasticity
Time frame: 75 minutes
Mechanical Stress Relaxation Time
Time frame: 75 minutes
Creep
Time frame: 75 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: No. Individual data will not be disclosed, because as participants are under eighteen
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Athletes, run by São Paulo State University 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 1 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: finished, as of the sponsor's last update on 6 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle Tone (time frame: 75 minutes). The study lists 2 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 6 Jan 2021.