- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02764840
Muscular Resistance Test in the Elastic Tube: Reliability and Training of the Proposed Method
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objectives of this study are: to assess the reliability of a method fatigue resistance assessment with elastic tube in two areas, inter and intra-examiner; check test reproducibility at different times with the same participant and compare this method with the gold standard of evaluation, the isokinetic dynamometer and compare the strength gains and endurance after the application of specific training in the elastic tube and an isokinetic dynamometer. It is a study of reproducibility, followed by application of a training protocol featuring a clinical trial.
Data collection will be held at the Center for Studies and Assistance in Physical Therapy and Rehabilitation (CEAFIR) FCT / UNESP, respecting the hours of 17:00 to 22:00. The study will be conducted in two stages: Reliability and reproducibility, and Training.
In the first stage of the study, the procedures will be conducted in six sessions. In the first, participants will be submitted to anthropometric measurements, questionnaires on physical activity level (IPAQ and Baecke) Contraction Maximum Voluntary (CVM) in isokinetic dynamometer test familiarization in the first analysis tool (elastic tube or isokinetic dynamometer) previously randomized. Randomization will be made by lot in Excel. It will be given interval of two days between the familiar and the first test.
In the second session, participants will perform the same test twice, with standardized interval of five minutes. In each test there will be a different supervisory therapist order to check whether or not the correlation between therapists.
In the third session, seven days after the initial tests, retests will be carried out by the same therapists who oversaw the previous session, aimed at finding or non-compliance of the information recorded in each of the therapists. In fitness tests, a seven-day period of separation is commonly used. For both the test will be played on two occasions separated by seven days.
In order to control possible biases, the order of application of the assessors in the test and retest will be crossed, and the first evaluating the test, shall be according reviewer on retest and vice versa. Furthermore, in all test sessions, it is inserted after the application of the first evaluator, a five minute rest and after, application of a Likert scale recovery Perception before the second evaluator start the test. If the participant reports of less than seven, it is understood that is not yet recovered and in these cases the scale is reapplied at intervals of one minute until the reported value exceeds seven. The choice of value is based on a priori knowledge acquired by pilot and respects the biological individuality of the participant. Although this age group and the sample health conditions non-recovery situations are exceptions, it is understood that the disposal of information is not adequate as far as the individual profile of each participant recovery. As the central object in this case is the test, it is the option for ensuring the inclusion of eligible study and use of the information with greater control of background levels of the participants. Such information is logged for further discussion. Tests conducted in both tools will be preceded by a warming of ten repetitions of knee flexion-extension of the dominant limb without charge.
Finalized the procedures in the first tool, the participants will undergo cross, starting in the fourth, fifth and sixth session procedures identical to the first three sessions, differing only the tool. This stage of the study will be cross over In the second stage of the study, the sample is again randomized and allocated to two groups (G1 and G2). The periodization of the groups will be identical, differing from the instrument and its features, which will be outlined in procedures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
-
Presidente Prudente, São Paulo, Brazil
- Paulista State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy young and physically active
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: experimental group isokinetic dynamometer (GEDI)
Isokinetic Biodex System Pro 4
|
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: experimental group elastic tube (GETE)
elastic tube brand LEMGRUBER 203
|
In the first stage a fatigue test will be applied.
In the second stage, different participants will undergo a protocol for muscle strength gain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reliability of the proposed test
Time Frame: up to four weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measure the gain endurance and strength
Time Frame: up to four weeks
|
In the second stage of the study participants will undergo a training protocol to gain muscle strength.
The primary outcome measure is the resistance and secondary force.Measurements will be performed on the isokinetic dynamometer, and measures shall be given in Nm
|
up to four weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jaqueline Silva, student, Sao Paulo State University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SaoPSU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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