Healthy Volunteers Clinical Trial
Official title:
Reliability and Validity of a Shoulder Fatigue Test Using Two Tools: Elastic Resistance and Isokinetic Dynamometer.
Verified date | November 2017 |
Source | São Paulo State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 30, 2017 |
Est. primary completion date | August 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Healthy - Male gender - Aged between 18 and 30 years - Agreement to participate through signed statement of informed consent Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Carlos Pastre, PhD | Presidente Prudente |
Lead Sponsor | Collaborator |
---|---|
São Paulo State University | Coordination for the Improvement of Higher Education Personnel |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Perception of effort | Evaluated through the OMNI Resistance Exercise Scale for Perceived Effort | 1 minute post test 1, 1 minute post test 2, 1 minute post test 3, 1 minute post test 4. | |
Secondary | Recovery Perception | Will be evaluated through the Likert Scale of Recovery Perception, with "one" corresponding to "not recovery" and 10 "fully recovery" | 10 minute post test 1, 10 minute post test 2, 10 minute post test 3, 10 minute post test 4. | |
Secondary | Psychological Questionnaire | 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 classification as previously described | Baseline | |
Secondary | Lactate concentration | After 10 minutes of rest ([lacR]) and at moments 3, 5, and 7 minutes after the test (to determine the peak lactate concentration ([lacP]), 25 µl of arterialized blood of the patient will be collected in heparinized capillaries. Ear lobe, and discarded in plastic tubes (polyethylene) type Eppendorf (1.5 mL) containing 50 µl of sodium fluoride (NaF - 1%), for later lactacidemia analysis, performed in a lactomer. | baseline, 3, 5 and 7 minutes after the first test with both tools (Stage 1 and Stage 2) | |
Secondary | Gas exchange | Measurement of gas exchange throughout the test and up to 7 minutes at the end. Time-to-exhaustion analysis and post-exercise oxygen uptake (COPD). | Immediately post test up to seven minutes post test | |
Secondary | Electromyographic measurements | In addition to the variables related to the strength signal (FP,% AV, TC and TS), and the maximum amplitude in the EMG signal reached at the moment of the electrical stimulation, called M-Wave. | 1 minute after the second test with both tools (Stage 1 and Stage 2) |
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