NCT02764840

Brief Summary

Resistance exercises from elastic tube has been used as part of the rehabilitation and maintenance of muscle tone levels in different scenarios, from disease conditions to the sports universe. There is the convenience and low cost of the instrument, which can provide impact on clinical and economic framework in case of spillage of use strategies. In a recent search, the investigators were not observed data on the reliability and reproducibility of a specific test for this tool and in this sense, it seems pertinent to undertake research on the topic. Objectives: To determine the reliability and reproducibility by comparison with a isokinetic muscle strength test located â fatigue held in elastic tube and compare the results of a training protocol for muscle strength gain in both methods, elastic tube and dynamometer. Methods: Participants will perform the muscular endurance test localized fatigue, on two occasions, with an interval of seven days between them. Everyone will accomplish so much in the elastic tube, as in the isokinetic dynamometer. It will be held evaluator analysis intra and inter evaluator. After first stage of the study to determine the reliability test, the participants will undergo three weeks of training to gain muscular endurance, distributed in two groups G1 (training in the elastic tube) and G2 (training in isokinetic dynamometer) previously randomized. It will use the intra-class correlation coefficient with 95% confidence interval to check the repeatability and the Kappa coefficient with 95% confidence interval for reproducibility. To compare the responses of training, the distribution will be made as to the normality of the data by the Kolmogorov-Smirnov test. In the case of normal distribution, the Student's t-test for unpaired data and Mann-Whitney will be adopted if there is no normal distribution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

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, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

December 2, 2015

Last Update Submit

April 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reliability of the proposed test

    In the first stage of the study analyzes will be performed to evaluate test reliability. Measurements will be performed on the isokinetic dynamometer, and measures shall be given in Nm

    up to four weeks

Secondary Outcomes (1)

  • measure the gain endurance and strength

    up to four weeks

Study Arms (2)

experimental group isokinetic dynamometer (GEDI)

EXPERIMENTAL

Isokinetic Biodex System Pro 4

Other: isokinetic dynamometer

experimental group elastic tube (GETE)

EXPERIMENTAL

elastic tube brand LEMGRUBER 203

Other: elastic tube

Interventions

In the first stage a fatigue test will be applied. In the second stage, different participants will undergo a protocol for muscle strength gain. The first stage of the study will be crossover. The second will be split, one arm carry out the procedures in the elastic tube and the other in isokinetic dynamometer.

experimental group isokinetic dynamometer (GEDI)

In the first stage a fatigue test will be applied. In the second stage, different participants will undergo a protocol for muscle strength gain.

experimental group elastic tube (GETE)

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy young and physically active

You may not qualify if:

  • be alcoholic, drug use, smoking or anti-inflammatory drugs chronically, present anemia, inflammation, diabetes, cardiovascular disease, liver problems and episode of muscle-tendon or osteo-articular lesions in the lower limbs and / or spine in the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paulista State University

Presidente Prudente, São Paulo, Brazil

Location

Study Officials

  • Jaqueline Silva, student

    São Paulo State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree student

Study Record Dates

First Submitted

December 2, 2015

First Posted

May 6, 2016

Study Start

February 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Locations