NCT03923608

Brief Summary

Introduction: Verification of the progression of individuals submitted to training programs is performed by diagnostic tests with a focus on strength and muscular endurance. Among the tools used are the elastic bands, the halter, the pulley, the digital dynamometer and, additionally, the isokinetic dynamometer, considered the gold standard of evaluation. However, there is a lack of standardization in assessments and scarcity in the exploration of some tools and some muscle groups. Observation is often restricted to a particular study design and makes comparisons difficult even with the use of the same tool. Thus, to include different clinical possibilities in the same scenario can enrich the discussion about the topic. Objective: To develop and analyze the validity and reliability of a maximal muscle strength test for the external rotator muscles of the shoulder in five tools; To develop and analyze the validity and reliability of a localized resistance test for the external rotator muscles of shoulder in three different percentages of maximum strength (60%, 70%, 80%) in four tools; To characterize by means of the physiological response the localized muscular endurance test with the load that presents with the highest reliability values in each tool. Method: The study will consist of a sample of 50 participants of both genders, and will be performed in 3 steps: (1) Validation and reliability of the maximum muscle strength test; (2) Reliability of the muscular endurance test (MET); (3) Physiological characterization of the muscular endurance test (MET). Stage 1 will be held in 3 sessions (familiarization, test and retest) in which participants will perform 5 tests of maximum strength with different tools (elastic bands, pulley, halter, digital dynamometer and isokinetic dynamometer). Stage 2, consisting of 6 sessions, will be tested and retest of a muscular endurance test with different loads (70%, 80% and 90% of maximum force) with the same devices of step 1, except the digital dynamometer. In Step 3 participants will be selected with the lowest variations between the test and retest in the variable "time" to perform the physiological characterization of the test with the different tools. In order to observe the physiological response, we will analyze the lactic anaerobic (lactate concentration), allelic anaerobic (post-exercise oxygen uptake (EPOC) and aerobic (VO 2 values) parameters). The statistical package SPSS Statistics 22.0 will be used to conduct the analyzes. Key words: Fatigue, Physical resistance, Muscle strength, Lactate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

April 15, 2019

Last Update Submit

September 17, 2019

Conditions

Outcome Measures

Primary Outcomes (10)

  • Maximal force (kilograms)

    The maximum force of the participant shall be measured with the values presented in kilogram

    Stage 1 - 0 minutes after strength test

  • Time (seconds)

    Stage 2 - 0 minutes after Endurance test

  • Number of repetitions

    Stage 2 -0 minutes after Endurance test

  • Anthropometric evaluation

    To determine the value corresponding to the body mass, the volunteers will be evaluated by a digital scale (Tanita BC554, Iron Man / Inner Scaner - Tanita, Illinois, United States). Stature values will be obtained by means of a stadiometer (Sanny - American Medical do Brasil, São Paulo, Brazil). From these values it will be possible to calculate the Body Mass Index (BMI), determined by the ratio of weight to height squared.

    Stage 1 - 10 minutes before stregth test

  • Psychological Questionnaire

    The questionnaire aims to subjectively document physical and metal readiness scores for exercise, fatigue, vigor, drowsiness, and muscle pain. Participants will be instructed to mark a dash on a visual analogue scale of 10 centimeters between two extremes, zero being "least possible" and 10 indicating "most possible" for each classification60. This questionnaire will be applied at the beginning of all sessions.

    Stage 1 - 10 minutes before stregth test

  • International Physical Activity Questionnaire (IPAQ)

    The IPAQ questionnaire is an instrument developed to estimate the level of habitual practice of physical activity. Sedentary - Does not perform any physical activity for at least 10 continuous minutes; Insufficiently Active - Individuals who engage in physical activity for at least 10 continuous minutes per week, but insufficiently to be classified as active. A) Perform 10 continuous minutes of physical activity, following at least one of the following criteria: frequency - 5 days/week or duration - 150 minutes/week; B) Does not meet any of the criteria of the recommendation cited in under-active individuals A; Active - a) vigorous physical activity - ≥ 3 days/week and ≥ 20 minutes/session; b) moderate or walking - ≥ 5 days/week and ≥ 30 minutes/session; c) any added activity: ≥ 5 day/week and ≥ 150 min/week; Very Active - a) vigorous - ≥ 5 days/week and ≥ 30 min/session; b) vigorous - ≥ 3 days/week and ≥ 20 min/session + moderate and or ≥ 5 days/week and ≥ 30 min/session.

    Stage 1 - 10 minutes before stregth test

  • Borg's Perception of Effort Scale

    The degree of subjective effort reported by the participants in relation to the upper limbs will be analyzed using the Borg scale of perception of effort of 6 to 20 points, 6 corresponding to the "very easy" and 20 to "exhaustive".

    Stage 2 - 0 minutes after endurance test in all tools

  • Perceived effort

    The perceived exertion of the resisted exercise will be evaluated through the OMNI Resistance Exercise Scale for Perceived Effort62,63, which consists of an ordinal scale of 0 to 10, 0 being extremely easy and 10 extremely difficult.

    Stage 2 - 0 minutes after endurance test in all tools

  • Recovery Perception

    The perception of recovery of the dominant lower limb will be evaluated through the Likert Scale of Recovery Perception, which consists of a scale with values between 1 and 10 points, 1 corresponding to no recovery and 10 to fully recovered

    Stage 2 - 10 minutes after endurance test in all tools

  • Participation of the anaerobic parameter

    The total participation of the anaerobic parameter (PANA) will be calculated by the sum of the lactary anaerobic (CLAC) and alactic (CALA) contributions, analyzed by \[lac\] and the excess of post-exercise oxygen consumption (EPOC), respectively.

    Stage 3 - During endurance test, until 7 minutes after test

Study Arms (2)

strength test

The maximum strength test of external shoulder rotators will be performed on 5 different tools with specific protocols.

Diagnostic Test: Maximal muscle strength Test

Endurance test

Test designed by the Laboratory of Sports Physical Therapy (LAFIDE) of FCT / UNESP - Presidente Prudente, used in the prescription of training for gain of localized muscular endurance. Will be realized in the tools: Isokinetic dynamometer, elastic bands, pulley and halter. The test will consist of the maximum possible repetitions (until fatigue) with loads of 70%, 80% and 90% of the maximum force (in different sessions).

Diagnostic Test: Exhaustion test

Interventions

1RM test performed in 5 different tools (Elastic Band, Pulley, halter, digital dynamometer and isokinetic dynamometer)

strength test
Exhaustion testDIAGNOSTIC_TEST

Test performed until individual exhaustion in 5 different tools (Elastic Band, Pulley, halter and isokinetic dynamometer)

Endurance test

Eligibility Criteria

Age13 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The sample is composed of apparently healthy young men, of both genders, between 13 and 30 years old.

You may qualify if:

  • anemia,
  • diabetes,
  • cardiovascular disease,
  • and upper limb and spinal muscular injuries in the last six months

You may not qualify if:

  • absence at any study session and
  • episode of muscle-tendon or osteoarticular injury in the upper limbs during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of são Paulo

Presidente Prudente, São Paulo, 19060-900, Brazil

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carlos Marcelo Pastre, PhD

    Universidade Estadual Paulista Júlio de Mesquita Filho

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 22, 2019

Study Start

February 1, 2019

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

September 18, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations