Reliability and Physiological Analysis of an Isometric Test of Localized Muscular Fatigue
Condition: Healthy Volunteers
MeSH terms: Fatigue
Study type: Interventional

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. 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.

      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.
    

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.
    

Intervention name(s): Reliability of IET; Physiological analysis of IET
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): The participants will be do three sessions: familiarization, test and retest to assess the reliability inter and intra rater of the 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other