NCT03072355

Brief Summary

Introduction: The exercise performed with elastic tools has been appearing in the current scenario as a clinical tool because it presents advantages such as easy handling, low cost and safety. However, its use as an assessment tool, specifically for localized muscular resistance, is reduced and not standardized. In addition, there are no records of the physiological / neurofunctional effects of tests that use such a tool, since it allows a differentiated degree of prescription. Objective: To determine the reliability and reproducibility of a shoulder abduction resistance test in two tools, elastic tube and isokinetic dynamometer. In addition to analyzing the metabolic profile of both comparative order and targeting subsequent training prescription. Method: The study will consist of a sample of 30 participants and will be carried out in 2 stages, 15 participants will perform step 1 and the other 15 will perform step 2. The difference between the steps is the order of the tools used to perform the test . Each stage will consist of 5 sessions (Orientation, Familiarization 1 and 2, Test and Retest). During the test and retest sessions the physiological response of the test will be analyzed. In order to observe the response, will be analyzed the lactic anaerobic parameter (lactate concentration), allelic anaerobic (post-exercise oxygen uptake analysis - EPOC), aerobic parameter (VO2 values) and electromyographic measurements. Will be used the statistical package SPSS Statistics 22.0, Pearson's correlation and their respective confidence intervals will indicate the relationship between the numerical variables and multivariate models will be constructed by means of linear regression. The significance level of 5% will be adopted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable healthy-volunteers

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

4 months

First QC Date

February 16, 2017

Last Update Submit

November 8, 2017

Conditions

Keywords

fatigueresistance test

Outcome Measures

Primary Outcomes (2)

  • Change in time values

    It will be divided into two stages. The 30 participants recruited will be randomized to perform the steps, 15 participants will perform step 1 and the other 15 participants will perform step 2. The difference between the participants is between the order of the procedures. In stage 1 the participants will perform 4 tests, the two tests initially with the device tube elastic the two ends with the isokinetic dynamometer, with 30 minutes interval between tests. For step 2, another 15 participants will perform the same procedures with the order of alternate tools. The change time values will be analyzed for reliability and reproducibility of the test.

    1 minute post test

  • Change in repetitions values

    It will be divided into two stages. The 30 participants recruited will be randomized to perform the steps, 15 participants will perform step 1 and the other 15 participants will perform step 2. The difference between the participants is between the order of the procedures. In stage 1 the participants will perform 4 tests, the two tests initially with the device tube elastic the two ends with the isokinetic dynamometer, with 30 minutes interval between tests. For step 2, another 15 participants will perform the same procedures with the order of alternate tools. The change on repetitions values will be analyzed for reliability and reproducibility of the test.

    1 minute post test

Secondary Outcomes (6)

  • Perception of effort

    1 minute post test 1, 1 minute post test 2, 1 minute post test 3, 1 minute post test 4.

  • Recovery Perception

    10 minute post test 1, 10 minute post test 2, 10 minute post test 3, 10 minute post test 4.

  • Psychological Questionnaire

    Baseline

  • Lactate concentration

    baseline, 3, 5 and 7 minutes after the first test with both tools (Stage 1 and Stage 2)

  • Gas exchange

    Immediately post test up to seven minutes post test

  • +1 more secondary outcomes

Study Arms (2)

Elastic Band

ACTIVE COMPARATOR

Perform the maximum of the possible repetition with a load of 50% of the 1RM (performing 1½ seconds in the concentric phase and 1½ seconds in the eccentric phase).

Other: Elastic Band

Isokinetic dynamometer

ACTIVE COMPARATOR

Realization of the maximum of the possible repetition to 50% of the MIVM in the speed of 60º / s for abduction and 500º / s in the return of the movement.

Other: Isokinetic dynamometer

Interventions

Localized muscle resistance test for shoulder

Elastic Band

Localized muscle resistance test for shoulder

Isokinetic dynamometer

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales between the ages of 18 and 30, apparently healthy
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Male gender
  • Aged between 18 and 30 years
  • Agreement to participate through signed statement of informed consent

You may not qualify if:

  • Be an alcoholic,
  • Consume drugs,
  • Consuming tobacco or anti-inflammatory medications in a chronic way,
  • Anemia, an inflammatory process, diabetes, cardiovascular disease, and
  • an episode of muscle-tendon or osteoarticular injury in the lower limbs and / or spine in the last six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carlos Pastre, PhD

Presidente Prudente, +551832295528, Brazil

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree student

Study Record Dates

First Submitted

February 16, 2017

First Posted

March 7, 2017

Study Start

May 1, 2017

Primary Completion

August 30, 2017

Study Completion

August 30, 2017

Last Updated

November 9, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations