Healthy VolunteersNCT03072355
Reliability and Validity of a Shoulder Fatigue Test
A study testing Elastic Band and Isokinetic dynamometer in people with Healthy Volunteers, run by São Paulo State University at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Elastic Band and Isokinetic dynamometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2017to 30 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Male gender
- Aged between 18 and 30 years
- Agreement to participate through signed statement of informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validity of a Shoulder Fatigue Test Using Two Tools: Elastic Resistance and Isokinetic Dynamometer.
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.
Read the detailed description
Tests applied
1RM test The 1 RM test in the elastic band is based on the study by ANDERSEN et al. (2016). Elastic bands of the brand Theraband® CLX (Hygienic, Corporation, Akron, Ohio, USA) with a standard length of 1.47m, ranging from very low to very high strength (yellow, red, green, blue, black, silver, gold). Due to possible changes in the mechanical properties of elastic bands during the initial stretching cycles, all elastics will be pre-stretched 100 times.
Initially the research assistant will instruct the participants to sit on a chair, and place their feet together on the elastic band without shoes. Starting with the least elastic resistance (yellow), the research assistant will instruct the participants to perform a shoulder abduction of a unilateral (dominant) shoulder up to 90 ° and hold such a position for 3 seconds (statically). Thus, participants will have to perform the concentric contraction phase without the help of the research assistant before reaching the static test position. Through visual inspection, the search assistant will control the correct positioning of the movement. Two-minute intervals will be taught between resistance levels until it is not possible for the participant to reach and / or hold the position for 3 seconds. When there is a failure, two more attempts to reach and maintain the desired position will be accomplished. During the essay, the research assistant will provide verbal encouragement. The obtained torque will be calculated by a formula based on the study of ANDERSEN et al. (2016).
Isokinetic muscle strength test For the MVIC test, the participant will be seated with the dominant upper limb on the Biodex System Pro 4 isokinetic dynamometer (Biodex Medical System, Shirley-NY, USA). Prior to the test, the participant will undergo a warm-up consisting of 10 repetitions of concentric contraction of abduction-adduction of the shoulder at 180º / s throughout the range of motion. After the warm-up will be given a two-minute rest break to the start of the MVIC. The CIVM will be considered as the Of torque obtained between three 5 second repetitions of abduction, with the dominant upper limb positioned at 90º horizontal abduction of the shoulder. A two-minute interval between replicates will be administered in order to minimize possible fatigue effects. The participant will be instructed to perform their maximum power performance and will be verbally encouraged by the evaluator in each attempt made. Such protocol is based on the one used by BARONI et al., (2010) for lower limb.
Fatigue Resistance Test (TRF) TRF - Elastic Tube: To perform the fatigue resistance test on the elastic tube the participant will initially be positioned sitting on a chair with their feet together stepping on the elastic band without shoes. He will then perform a 20-second abduction-adduction heating of the shoulder from the neutral position to 90 °. The interval of 2 minutes will then be given to start the TRF. This will consist of performing the maximum of the possible repetition with a load of 50% of the 1RM (1½ second in the concentric phase and 1½ second in the eccentric phase).
TRF - Isokinetic Dynamometer: In order to perform the fatigue resistance test in the isokinetic dynamometer, the participant will initially be positioned with the dominant upper limb attached to the dynamometer by means of the apparatus itself. He will then perform a warm-up of 10 concentric contractions of abduction-adduction of the shoulder at 180º / s throughout the range of movement (0º to 90º). The interval of 2 minutes will then be given to start the TRF. This will consist of performing the maximum possible repetition at 50% of the MVIC at the rate of 60º / s for abduction and 500º / s at the return of the movement.
- Conditions
- Healthy Volunteers
- Being tested
- Elastic Band, Isokinetic dynamometer
- Keywords
- fatigue, resistance test
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic BandOther
Localized muscle resistance test for shoulder
Isokinetic dynamometerOther
Localized muscle resistance test for shoulder
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Isokinetic dynamometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 minute post test
Secondary outcomes (6)
Perception of effort
Evaluated through the OMNI Resistance Exercise Scale for Perceived Effort
Measured: 1 minute post test 1, 1 minute post test 2, 1 minute post test 3, 1 minute post test 4.
Recovery Perception
Will be evaluated through the Likert Scale of Recovery Perception, with "one" corresponding to "not recovery" and 10 "fully recovery"
Measured: 10 minute post test 1, 10 minute post test 2, 10 minute post test 3, 10 minute post test 4.
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
Measured: Baseline
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.
Measured: baseline, 3, 5 and 7 minutes after the first test with both tools (Stage 1 and Stage 2)
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).
Measured: Immediately post test up to seven minutes post test
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.
Measured: 1 minute after the second test with both tools (Stage 1 and Stage 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start1 May 2017
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Collaborators
- Coordination for the Improvement of Higher Education Personnel
- Responsible party
- Principal investigator, Jaqueline Santos Silva, São Paulo State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072355
- Sponsor's protocol ID
- PP1
- Status last verified
- Nov 2017
- First submitted
- 16 Feb 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of a Shoulder Fatigue Test Using Two Tools: Elastic Resistance and Isokinetic Dynamometer.
- ClinicalTrials.gov ID
- NCT03072355
- Acronym / sponsor ID
- PP1
- Conditions
- Healthy Volunteers
- Keywords
- fatigue, resistance test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Collaborators
- Coordination for the Improvement of Higher Education Personnel
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tests applied
1RM test The 1 RM test in the elastic band is based on the study by ANDERSEN et al. (2016). Elastic bands of the brand Theraband® CLX (Hygienic, Corporation, Akron, Ohio, USA) with a standard length of 1.47m, ranging from very low to very high strength (yellow, red, green, blue, black, silver, gold). Due to possible changes in the mechanical properties of elastic bands during the initial stretching cycles, all elastics will be pre-stretched 100 times.
Initially the research assistant will instruct the participants to sit on a chair, and place their feet together on the elastic band without shoes. Starting with the least elastic resistance (yellow), the research assistant will instruct the participants to perform a shoulder abduction of a unilateral (dominant) shoulder up to 90 ° and hold such a position for 3 seconds (statically). Thus, participants will have to perform the concentric contraction phase without the help of the research assistant before reaching the static test position. Through visual inspection, the search assistant will control the correct positioning of the movement. Two-minute intervals will be taught between resistance levels until it is not possible for the participant to reach and / or hold the position for 3 seconds. When there is a failure, two more attempts to reach and maintain the desired position will be accomplished. During the essay, the research assistant will provide verbal encouragement. The obtained torque will be calculated by a formula based on the study of ANDERSEN et al. (2016).
Isokinetic muscle strength test For the MVIC test, the participant will be seated with the dominant upper limb on the Biodex System Pro 4 isokinetic dynamometer (Biodex Medical System, Shirley-NY, USA). Prior to the test, the participant will undergo a warm-up consisting of 10 repetitions of concentric contraction of abduction-adduction of the shoulder at 180º / s throughout the range of motion. After the warm-up will be given a two-minute rest break to the start of the MVIC. The CIVM will be considered as the Of torque obtained between three 5 second repetitions of abduction, with the dominant upper limb positioned at 90º horizontal abduction of the shoulder. A two-minute interval between replicates will be administered in order to minimize possible fatigue effects. The participant will be instructed to perform their maximum power performance and will be verbally encouraged by the evaluator in each attempt made. Such protocol is based on the one used by BARONI et al., (2010) for lower limb.
Fatigue Resistance Test (TRF) TRF - Elastic Tube: To perform the fatigue resistance test on the elastic tube the participant will initially be positioned sitting on a chair with their feet together stepping on the elastic band without shoes. He will then perform a 20-second abduction-adduction heating of the shoulder from the neutral position to 90 °. The interval of 2 minutes will then be given to start the TRF. This will consist of performing the maximum of the possible repetition with a load of 50% of the 1RM (1½ second in the concentric phase and 1½ second in the eccentric phase).
TRF - Isokinetic Dynamometer: In order to perform the fatigue resistance test in the isokinetic dynamometer, the participant will initially be positioned with the dominant upper limb attached to the dynamometer by means of the apparatus itself. He will then perform a warm-up of 10 concentric contractions of abduction-adduction of the shoulder at 180º / s throughout the range of movement (0º to 90º). The interval of 2 minutes will then be given to start the TRF. This will consist of performing the maximum possible repetition at 50% of the MVIC at the rate of 60º / s for abduction and 500º / s at the return of the movement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elastic Band | Active comparator | Other: Elastic BandPerform 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). |
| Isokinetic dynamometer | Active comparator | Other: Isokinetic dynamometerRealization 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Male gender
- Aged between 18 and 30 years
- Agreement to participate through signed statement of informed consent
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastic BandLocalized muscle resistance test for shoulder | Other | Elastic Band |
| Isokinetic dynamometerLocalized muscle resistance test for shoulder | Other | Isokinetic dynamometer |
Primary outcome
Change in time values
Time frame: 1 minute post test
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.
Change in repetitions values
Time frame: 1 minute post test
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.
6 secondary outcomes
Perception of effort
Time frame: 1 minute post test 1, 1 minute post test 2, 1 minute post test 3, 1 minute post test 4.
Recovery Perception
Time frame: 10 minute post test 1, 10 minute post test 2, 10 minute post test 3, 10 minute post test 4.
Psychological Questionnaire
Time frame: Baseline
Lactate concentration
Time frame: baseline, 3, 5 and 7 minutes after the first test with both tools (Stage 1 and Stage 2)
Gas exchange
Time frame: Immediately post test up to seven minutes post test
Electromyographic measurements
Time frame: 1 minute after the second test with both tools (Stage 1 and Stage 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Individual participant dataSharing planned: No
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Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic Band and Isokinetic dynamometer in people with Healthy Volunteers, run by São Paulo State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time values (time frame: 1 minute post test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.