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

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ClinicalTrials.gov Identifier: NCT03373747
Recruitment Status : Completed
First Posted : December 14, 2017
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Larissa Rodrigues Souto, Universidade Estadual Paulista Júlio de Mesquita Filho

Brief 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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Diagnostic Test: Reliability of IET Diagnostic Test: Physiological analysis of IET Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Reliability Intra and Inter-evaluators and Physiological Analysis of an Isometric Test of Localized Muscular Fatigue
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: Reliability of IET
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.
Diagnostic Test: Reliability of IET
The participants will be do three sessions: familiarization, test and retest to assess the reliability inter and intra rater of the test.

Experimental: Physiological analysis of IET
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.
Diagnostic Test: Physiological analysis of IET
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.




Primary Outcome Measures :
  1. The time of execution of the test [ Time Frame: 45 seconds after the beginning of the test ]
    This outcome will be assessed in seconds during execution of the test


Secondary Outcome Measures :
  1. The work of the test [ Time Frame: day 2 and day 7 ]
    This outcome will be assessed in Newton.meter (N.m) during execution of the test

  2. Oxygen consumption - gas analysis [ Time Frame: Second phase during all the test ]
    Gas analysis will be measured during the test and after seven minutes of the same (VO2000, MedGraphics, Minnesota, USA).

  3. Blood lactate concentration [ Time Frame: 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 ]
    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

  4. Muscular activation percentage [ Time Frame: Day 2 ]
    The muscular activation percentage will be assessed by means of twitch interpolation technique ( current generator - Quark)

  5. Psychological Questionnaire [ Time Frame: Day 2 and day 7 ]
    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

  6. Work Ability Index Questionnaire [ Time Frame: Day 1 ]
    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

  7. Perceived Stress Scale [ Time Frame: Day 1 ]
    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

  8. Bergen Insomnia Scale [ Time Frame: Day 1 ]
    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

  9. Need for Recovery Scale [ Time Frame: Day 7 ]
    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

  10. Borg Scale [ Time Frame: Day 7 ]
    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".

  11. Borg CR10 Scale [ Time Frame: Day 7 ]
    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.

  12. Effort Perception Scale [ Time Frame: Day 1, day 2 and day 7 ]
    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

  13. Recovery Perception Scale [ Time Frame: Day 1, day 2 and day 7 ]
    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

  14. Heart Rate [ Time Frame: Day 2 and day 7 ]
    The heart rate caption will take place using a cardio frequency meter (Polar electro, Oy Kempele, Finland - V800 model)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373747


Locations
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Brazil
Larissa Rodrigues Larissa Rodrigues Souto
Presidente Prudente, SP, Brazil, 19060-900
Larissa Rodrigues Souto
Presidente Prudente, SP, Brazil, 19060-900
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Carlos Pastre, PhD Univ Estadual Paulista

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Responsible Party: Larissa Rodrigues Souto, Principal Investigator, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03373747     History of Changes
Other Study ID Numbers: 2016/11785-7
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms