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

NCT03373747 | Completed DMC

• 1 other identifier: 2016/11785-7
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• The time of execution of the test

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

  45 seconds after the beginning of the test

Secondary Outcomes (14)

• The work of the test

  day 2 and day 7

• Oxygen consumption - gas analysis

  Second phase during all the test

• Blood lactate concentration

  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

• Muscular activation percentage

  Day 2

• Psychological Questionnaire

  Day 2 and day 7

Study Arms (2)

Reliability of IET

EXPERIMENTAL

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

Physiological analysis of IET

EXPERIMENTAL

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

Interventions

Reliability of IET DIAGNOSTIC_TEST

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

Reliability of IET

Physiological analysis of IET DIAGNOSTIC_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.

Physiological analysis of IET

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (2)

Larissa Rodrigues Larissa Rodrigues Souto

Presidente Prudente, São Paulo, 19060-900, Brazil

Location

Larissa Rodrigues Souto

Presidente Prudente, São Paulo, 19060-900, Brazil

Location

Study Officials

• Carlos Pastre, PhD

  Univ Estadual Paulista

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 14, 2017
• Study Start: October 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)