AzTrials
AzTrials

Healthy VolunteersNCT03373747

Reliability and Physiological Analysis of an Isometric Test of Localized Muscular Fatigue

A study testing Reliability of IET and Physiological analysis of IET in people with Healthy Volunteers, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Introduction: The isokinetic dynamometer, considered a gold standard tool for physical evaluation, is widely used in studies that aim to evaluate the reliability and reproducibility of localized muscular endurance (LME) tests. However, such tests may not represent full LME by fixing time or number of replicates. 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 Volunteers
What is being tested?
Reliability of IET and Physiological analysis of IET
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesBrazil
Study dates
1 Oct 2017to 1 Sep 2018
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

  • Healthy (self-report);
  • Male gender;
  • Aged between 18-30 years;
  • Agreement to participate through signed statement of informed

Who cannot join

  • Being sick;
  • Training or physical activity at least 24 hours priot to the application test;
  • Being influenced in some way by test information;
  • Do not understand the test;
  • Inflammatory process;
  • Cardiovascular disease;
  • Episode of musculo-tendinous or osteoarticular lesion in the lower limbs and/or spine in the last seix months;

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites
  • Larissa Rodrigues Larissa Rodrigues Souto

    Presidente Prudente, São Paulo, 19060-900

  • Larissa Rodrigues Souto

    Presidente Prudente, São Paulo, 19060-900

Other trials in Brazil

About this study

Official title: Reliability Intra and Inter-evaluators and Physiological Analysis of an Isometric Test of Localized Muscular Fatigue

Introduction: The isokinetic dynamometer, considered a gold standard tool for physical evaluation, is widely used in studies that aim to evaluate the reliability and reproducibility of localized muscular endurance (LME) tests. However, such tests may not represent full LME by fixing time or number of replicates. Therefore, it is relevant to construct a test that respects the actual capacity of each subject to withstand fatigue and to submit such a test to validation, as well as to physiological analysis.

Research objectives: To assess the inter- and intra-rater reliability of a localized isometric endurance test (IET) on the isokinetic dynamometer and to establish the metabolic demand required during the test.

Read more

Design: Reliability study with test-reteste dynamic.

Participants and Setting: After fulfilling the eligibility criteria, eighty-eight male participants will participate in the study.

Procedure: In phase 1 forty-eight participants will submitted to reliability of the IET within three sessions: familiarization session, test session and retest sessio. In phase 2 forty participants will be submitted the metabolic demand required during the IET will be analyzed by means of gas analysis, blood lactat concetrate and muscular activation percentage.

Intervention: isometric endurance teste.

Measurements: The measurements include time of execution of test, work of test, physiological and psychological outcomes.

Read the detailed description

Introduction: The isokinetic dynamometer, considered a gold standard tool for physical evaluation, is widely used in studies that aim to evaluate the reliability and reproducibility of localized muscular endurance (LME) tests. However, such tests may not represent full LME by fixing time or number of replicates. Therefore, it is relevant to construct a test that respects the actual capacity of each subject to withstand fatigue and to submit such a test to validation, as well as to physiological analysis.

Research objectives: To assess the inter- and intra-rater reliability of a localized isometric endurance test (IET) on the isokinetic dynamometer and to establish the metabolic demand required during the test.

Design: Reliability study with test-reteste dynamic.

Participants and Setting: After fulfilling the eligibility criteria, eighty-eight male participants will participate in the study. The inclusion criteria include: healthy male, aged between 18-30 years who agree to participate in the study. Participants with the following will be excluded from the study: presence of anemia, inflammation, being sick, training or physical activity at least 24 hours prior the application of the test, being influenced in some way by test information, do not understand the teste and occurrence of musculoskeletal injury during the study.

Procedure: In phase 1 forty-eight participants will submitted to reliability of the IET within three sessions: familiarization session, test session and retest sessio. In phase 2 forty participants will be submitted the metabolic demand required during the IET will be analyzed by means of gas analysis, blood lactat concetrate and muscular activation percentage.

Intervention: This is a test that was developed by the Laboratory of Sports Physiotherapy of FCT/UNESP - Presidente Prudente. The test will be performed on the Biodex System Pro 4 isokinetic dynamometer (Biodex Medical System, Shirley-NY, USA). At first, participants will be be positioned and fixed on the device itself by their trunk, hips, thighs and by the distal region of the assessed lower limb (dominant). The protocol is composed by a 10 knee flexo-extension warm up at the speed of 330º/s, respecting the amplitude of 90º, then a 30 second isometric contraction from 50% to 60% of the maximum participant effort, according to the Effort Perception Scale. The test starts after two minutes of rest. So that it can take place, participants will be instructed to make as much effort as possible, according to the same scale, for as long as possible, until they can't keep muscle contraction no longer. To stimulate participants, evaluators will offer verbal motivation and they will follow a monitor, coupled to the device, which offers the power generation line which works as a visual feedback during all test long.

In phase 1, the first of familiarization is to the participants understand the test and familiarize with the equipment after 24 to 48 hours, the participants will do the test applied twice at the same day with 10 minutes of rest. For realization of the IET the participants will be instructe to make the maximum effort as possible and mantain until they can't resiste. After one week the retest session will be doing. The order between the evaluators will be changed in the test and retest sessions. In phase 2, the participants will be submitted two sessions, familiarization session and test session. In the test session there is be two teste applied in the same day with approximately 20 minutes of rest. In the first test, thers is gas analysis during all the test until seven minutes after the test and blood lactat concentrate will be colected before the test with 10 minutes of rest, immediately after the teste and in the first, in the third, fifth and seventh minutes after the test. In the second test will be assess the muscular activation porcentage of lateral vastus muscle by means of twitch interpolation technique there is be performe before and after the test.

Measurements: The measurements include time of execution of test (in seconds), work of test (in N.m), physiological (gas analysis, blood lactate concentration, muscular activation percentage) and psychological outcomes (Psychological Questionnaire, Work Ability Index Questionnaire, Perceived Stress Scale, The Bergen Insomnia Scale, Need for Recovery Scale, The Borg Scale, The Borg CR10 Scale, The Effort Perception Scale and Recovery Perception Scale) and clinical outcomes (heart rate).

Analysis: To analyse the normality will be used Shapiro Wilk test. For analysis of reliability test-retest will be used the intraclasse correlation coefficient (ICC), with confidence interval of 95% to reliability relative. To assess the reliability absolute the typical error and coefficient of variation will be done. The paired test t will be do to verify diferences n the mean of the groups. The psychological outcomes wiil be done with correlation and linear regression as well the physiologica outcomes. A significance level of 5% will be assumed for all statistical analysis.

Being tested
Reliability of IET, Physiological analysis of IET

What participants receive

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

  • Reliability of IETDiagnostic test

    The participants will be do three sessions: familiarization, test and retest to assess the reliability inter and intra rater of the test.

  • Physiological analysis of IETDiagnostic test

    The participants will be submitted two sessions, familiarization session and test session. In the test session there will be the physiological analysis by means of gas analysis, blood lactate concentrate and activation muscular percentage.

Study groups in NCT03373747
Study groupRoleWhat they receive
Reliability of IETExperimentalIn phase 1, the first of familiarization is to the participants understand the test and familiarize with the equipment after 24 to 48 hours, the participants will do the test applied twice at the same day with 10 minutes of rest. For realization of the IET the participants will be instructe to make the maximum effort as possible and mantain until they can't resiste. After one week the retest session will be doing. The order between the evaluators will be changed in the test and retest sessions.
Receives: Diagnostic Test: Reliability of IET
Physiological analysis of IETExperimentalIn phase 2, the participants will be submitted two sessions, familiarization session and test session. In the test session there is be two teste applied in the same day with approximately 20 minutes of rest. In the first test, thers is gas analysis during all the test until seven minutes after the test and blood lactat concentrate will be colected before the test with 10 minutes of rest, immediately after the teste and in the first, in the third, fifth and seventh minutes after the test. In the second test will be assess the muscular activation porcentage of lateral vastus muscle by means of twitch interpolation technique there is be performe before and after the test.
Receives: Diagnostic Test: Physiological analysis of IET

What is being measured

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

  1. The time of execution of the test

    This outcome will be assessed in seconds during execution of the test

    Measured: 45 seconds after the beginning of the test

Secondary outcomes (14)
  1. The work of the test

    This outcome will be assessed in Newton.meter (N.m) during execution of the test

    Measured: day 2 and day 7

  2. Oxygen consumption - gas analysis

    Gas analysis will be measured during the test and after seven minutes of the same (VO2000, MedGraphics, Minnesota, USA).

    Measured: Second phase during all the test

  3. Blood lactate concentration

    The blood lactate concentration will be collected in the 10 minutes of rest before the test and immediately after the test and in the third, fifth and seven minutes after the test

    Measured: Second phase, 10 minutes of rest before the test and immediately after the test and in the third, fifth and seven minutes after the test

  4. Muscular activation percentage

    The muscular activation percentage will be assessed by means of twitch interpolation technique ( current generator - Quark)

    Measured: Day 2

  5. Psychological Questionnaire

    Participants will be instructed to mark with a dash, on a 10 centimeters analogical visual scale in between two extremes, in which zero means "non-existent" and 10 "very intense" to each classification

    Measured: Day 2 and day 7

  6. Work Ability Index Questionnaire

    This questionnaire consists in seven indicators, which provide a score between seven and 49, in which the highest the scores the better. These indicators evaluate occupational wellness, providing subjective estimation about work capacity, including the ability to perform work tasks in relation to demands, health and mental resources

    Measured: Day 1

  7. Perceived Stress Scale

    This scale is intended to document participants' related stress on the previous month. Items evaluate the degree to which people find life unpredictable, uncontrollable or overloaded. This scale evaluates overall beliefs about perceived stress, without the providence of any specific event lists in life to the subjects, allowing these scores not to be biased by the event content or difference of previous life experience

    Measured: Day 1

  8. Bergen Insomnia Scale

    This scale is intended to evaluate participants' sleep and tiredness, which consists in six questions about sleep issues in the previous month. Questions are about (1) problems initiating sleep, (2) awakening from sleep, (3) early morning awakening, (4) not feeling adequately rested, (5) experiencing daytime impairment and (6) being dissatisfied with sleep. To each question participants will answer on a zero to seven days a week scale. The quantity of days will be calculated based on the average of the answers to these six questions, in order to obtain an overall sleep problems score

    Measured: Day 1

  9. Need for Recovery Scale

    This is an 11 item scale which aims to evaluate work fatigue symptoms, related to a series of emotional, cognitive and behavioral aspects characterized as temporary overload feelings, irritability, social seclusion, lack of energy for new efforts and performance reduction

    Measured: Day 7

  10. Borg Scale

    Participants' physical effort perception will also be measured by the Borg Scale, which will be used to correlate with heart rate values. After the completion of IET participants willl answer the following question: "How much exertion did you experience during the test? ". This scale has 15 possible answers, ranging from six to 20, represented respectively from "not exertion at all" to "maximal exertion".

    Measured: Day 7

  11. Borg CR10 Scale

    Participants' physical effort perception will be measured by The Borg CR10 Scale. After the IET application participants will answer the following question: "How much exertion did you experience during the test? ". This scale has 16 possible answers which vary from zero to 10 represented respectively from no effort to maximum effort.

    Measured: Day 7

  12. Effort Perception Scale

    The effort perception will be evaluated by the Effort Perception Scale, with values between 0 and 10, 0 being correspondent to no effort at all (rest) and 10, to maximum effort

    Measured: Day 1, day 2 and day 7

  13. Recovery Perception Scale

    The perceived recovery of the dominant lower limb will be assessed by means of the Effort Perception Scale, which consists of a 10-point Likert Scale, in which 1 means no recovery and 10, completely recovered

    Measured: Day 1, day 2 and day 7

  14. Heart Rate

    The heart rate caption will take place using a cardio frequency meter (Polar electro, Oy Kempele, Finland - V800 model)

    Measured: Day 2 and day 7

Timeline

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

  1. First posted14 Dec 2017
  2. Study start1 Oct 2017
  3. Primary completion1 Jul 2018
  4. Study completion1 Sep 2018

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03373747
Sponsor's protocol ID
2016/11785-7
Other IDs
2016
Status last verified
Mar 2019
First submitted
21 Nov 2017
Last updated
25 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Reliability of IET and Physiological analysis of IET in people with Healthy Volunteers, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 2 sites 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 4 inclusion and 7 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 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The time of execution of the test (time frame: 45 seconds after the beginning of the test). 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 25 Mar 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in