Healthy VolunteersNCT03373747
Reliability and Physiological Analysis of an Isometric Test of Localized Muscular Fatigue
A study testing Reliability of IET and Physiological analysis of IET in people with Healthy Volunteers, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 2 sites in Brazil.
Trial summary
Introduction: The isokinetic dynamometer, considered a gold standard tool for physical evaluation, is widely used in studies that aim to evaluate the reliability and reproducibility of localized muscular endurance (LME) tests. However, such tests may not represent full LME by fixing time or number of replicates. 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?
- Reliability of IET and Physiological analysis of IET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Oct 2017to 1 Sep 2018
- 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 (self-report);
- Male gender;
- Aged between 18-30 years;
- Agreement to participate through signed statement of informed
Who cannot join
- Being sick;
- Training or physical activity at least 24 hours priot to the application test;
- Being influenced in some way by test information;
- Do not understand the test;
- Inflammatory process;
- Cardiovascular disease;
- Episode of musculo-tendinous or osteoarticular lesion in the lower limbs and/or spine in the last seix months;
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Larissa Rodrigues Larissa Rodrigues Souto
Presidente Prudente, São Paulo, 19060-900
Larissa Rodrigues Souto
Presidente Prudente, São Paulo, 19060-900
About this study
Official title: Reliability Intra and Inter-evaluators and Physiological Analysis of an Isometric Test of Localized Muscular Fatigue
Introduction: The isokinetic dynamometer, considered a gold standard tool for physical evaluation, is widely used in studies that aim to evaluate the reliability and reproducibility of localized muscular endurance (LME) tests. However, such tests may not represent full LME by fixing time or number of replicates. Therefore, it is relevant to construct a test that respects the actual capacity of each subject to withstand fatigue and to submit such a test to validation, as well as to physiological analysis.
Research objectives: To assess the inter- and intra-rater reliability of a localized isometric endurance test (IET) on the isokinetic dynamometer and to establish the metabolic demand required during the test.
Read more
Design: Reliability study with test-reteste dynamic.
Participants and Setting: After fulfilling the eligibility criteria, eighty-eight male participants will participate in the study.
Procedure: In phase 1 forty-eight participants will submitted to reliability of the IET within three sessions: familiarization session, test session and retest sessio. In phase 2 forty participants will be submitted the metabolic demand required during the IET will be analyzed by means of gas analysis, blood lactat concetrate and muscular activation percentage.
Intervention: isometric endurance teste.
Measurements: The measurements include time of execution of test, work of test, physiological and psychological outcomes.
Read the detailed description
Introduction: The isokinetic dynamometer, considered a gold standard tool for physical evaluation, is widely used in studies that aim to evaluate the reliability and reproducibility of localized muscular endurance (LME) tests. However, such tests may not represent full LME by fixing time or number of replicates. Therefore, it is relevant to construct a test that respects the actual capacity of each subject to withstand fatigue and to submit such a test to validation, as well as to physiological analysis.
Research objectives: To assess the inter- and intra-rater reliability of a localized isometric endurance test (IET) on the isokinetic dynamometer and to establish the metabolic demand required during the test.
Design: Reliability study with test-reteste dynamic.
Participants and Setting: After fulfilling the eligibility criteria, eighty-eight male participants will participate in the study. The inclusion criteria include: healthy male, aged between 18-30 years who agree to participate in the study. Participants with the following will be excluded from the study: presence of anemia, inflammation, being sick, training or physical activity at least 24 hours prior the application of the test, being influenced in some way by test information, do not understand the teste and occurrence of musculoskeletal injury during the study.
Procedure: In phase 1 forty-eight participants will submitted to reliability of the IET within three sessions: familiarization session, test session and retest sessio. In phase 2 forty participants will be submitted the metabolic demand required during the IET will be analyzed by means of gas analysis, blood lactat concetrate and muscular activation percentage.
Intervention: This is a test that was developed by the Laboratory of Sports Physiotherapy of FCT/UNESP - Presidente Prudente. The test will be performed on the Biodex System Pro 4 isokinetic dynamometer (Biodex Medical System, Shirley-NY, USA). At first, participants will be be positioned and fixed on the device itself by their trunk, hips, thighs and by the distal region of the assessed lower limb (dominant). The protocol is composed by a 10 knee flexo-extension warm up at the speed of 330º/s, respecting the amplitude of 90º, then a 30 second isometric contraction from 50% to 60% of the maximum participant effort, according to the Effort Perception Scale. The test starts after two minutes of rest. So that it can take place, participants will be instructed to make as much effort as possible, according to the same scale, for as long as possible, until they can't keep muscle contraction no longer. To stimulate participants, evaluators will offer verbal motivation and they will follow a monitor, coupled to the device, which offers the power generation line which works as a visual feedback during all test long.
In phase 1, the first of familiarization is to the participants understand the test and familiarize with the equipment after 24 to 48 hours, the participants will do the test applied twice at the same day with 10 minutes of rest. For realization of the IET the participants will be instructe to make the maximum effort as possible and mantain until they can't resiste. After one week the retest session will be doing. The order between the evaluators will be changed in the test and retest sessions. In phase 2, the participants will be submitted two sessions, familiarization session and test session. In the test session there is be two teste applied in the same day with approximately 20 minutes of rest. In the first test, thers is gas analysis during all the test until seven minutes after the test and blood lactat concentrate will be colected before the test with 10 minutes of rest, immediately after the teste and in the first, in the third, fifth and seventh minutes after the test. In the second test will be assess the muscular activation porcentage of lateral vastus muscle by means of twitch interpolation technique there is be performe before and after the test.
Measurements: The measurements include time of execution of test (in seconds), work of test (in N.m), physiological (gas analysis, blood lactate concentration, muscular activation percentage) and psychological outcomes (Psychological Questionnaire, Work Ability Index Questionnaire, Perceived Stress Scale, The Bergen Insomnia Scale, Need for Recovery Scale, The Borg Scale, The Borg CR10 Scale, The Effort Perception Scale and Recovery Perception Scale) and clinical outcomes (heart rate).
Analysis: To analyse the normality will be used Shapiro Wilk test. For analysis of reliability test-retest will be used the intraclasse correlation coefficient (ICC), with confidence interval of 95% to reliability relative. To assess the reliability absolute the typical error and coefficient of variation will be done. The paired test t will be do to verify diferences n the mean of the groups. The psychological outcomes wiil be done with correlation and linear regression as well the physiologica outcomes. A significance level of 5% will be assumed for all statistical analysis.
- Conditions
- Healthy Volunteers
- Being tested
- Reliability of IET, Physiological analysis of IET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reliability of IETDiagnostic test
The participants will be do three sessions: familiarization, test and retest to assess the reliability inter and intra rater of the test.
Physiological analysis of IETDiagnostic test
The participants will be submitted two sessions, familiarization session and test session. In the test session there will be the physiological analysis by means of gas analysis, blood lactate concentrate and activation muscular percentage.
| Study group | Role | What they receive |
|---|---|---|
| Reliability of IET | Experimental | In phase 1, the first of familiarization is to the participants understand the test and familiarize with the equipment after 24 to 48 hours, the participants will do the test applied twice at the same day with 10 minutes of rest. For realization of the IET the participants will be instructe to make the maximum effort as possible and mantain until they can't resiste. After one week the retest session will be doing. The order between the evaluators will be changed in the test and retest sessions. Receives: Diagnostic Test: Reliability of IET |
| Physiological analysis of IET | Experimental | In phase 2, the participants will be submitted two sessions, familiarization session and test session. In the test session there is be two teste applied in the same day with approximately 20 minutes of rest. In the first test, thers is gas analysis during all the test until seven minutes after the test and blood lactat concentrate will be colected before the test with 10 minutes of rest, immediately after the teste and in the first, in the third, fifth and seventh minutes after the test. In the second test will be assess the muscular activation porcentage of lateral vastus muscle by means of twitch interpolation technique there is be performe before and after the test. Receives: Diagnostic Test: Physiological analysis of IET |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of execution of the test
This outcome will be assessed in seconds during execution of the test
Measured: 45 seconds after the beginning of the test
Secondary outcomes (14)
The work of the test
This outcome will be assessed in Newton.meter (N.m) during execution of the test
Measured: day 2 and day 7
Oxygen consumption - gas analysis
Gas analysis will be measured during the test and after seven minutes of the same (VO2000, MedGraphics, Minnesota, USA).
Measured: Second phase during all the test
Blood lactate concentration
The blood lactate concentration will be collected in the 10 minutes of rest before the test and immediately after the test and in the third, fifth and seven minutes after the test
Measured: Second phase, 10 minutes of rest before the test and immediately after the test and in the third, fifth and seven minutes after the test
Muscular activation percentage
The muscular activation percentage will be assessed by means of twitch interpolation technique ( current generator - Quark)
Measured: Day 2
Psychological Questionnaire
Participants will be instructed to mark with a dash, on a 10 centimeters analogical visual scale in between two extremes, in which zero means "non-existent" and 10 "very intense" to each classification
Measured: Day 2 and day 7
Work Ability Index Questionnaire
This questionnaire consists in seven indicators, which provide a score between seven and 49, in which the highest the scores the better. These indicators evaluate occupational wellness, providing subjective estimation about work capacity, including the ability to perform work tasks in relation to demands, health and mental resources
Measured: Day 1
Perceived Stress Scale
This scale is intended to document participants' related stress on the previous month. Items evaluate the degree to which people find life unpredictable, uncontrollable or overloaded. This scale evaluates overall beliefs about perceived stress, without the providence of any specific event lists in life to the subjects, allowing these scores not to be biased by the event content or difference of previous life experience
Measured: Day 1
Bergen Insomnia Scale
This scale is intended to evaluate participants' sleep and tiredness, which consists in six questions about sleep issues in the previous month. Questions are about (1) problems initiating sleep, (2) awakening from sleep, (3) early morning awakening, (4) not feeling adequately rested, (5) experiencing daytime impairment and (6) being dissatisfied with sleep. To each question participants will answer on a zero to seven days a week scale. The quantity of days will be calculated based on the average of the answers to these six questions, in order to obtain an overall sleep problems score
Measured: Day 1
Need for Recovery Scale
This is an 11 item scale which aims to evaluate work fatigue symptoms, related to a series of emotional, cognitive and behavioral aspects characterized as temporary overload feelings, irritability, social seclusion, lack of energy for new efforts and performance reduction
Measured: Day 7
Borg Scale
Participants' physical effort perception will also be measured by the Borg Scale, which will be used to correlate with heart rate values. After the completion of IET participants willl answer the following question: "How much exertion did you experience during the test? ". This scale has 15 possible answers, ranging from six to 20, represented respectively from "not exertion at all" to "maximal exertion".
Measured: Day 7
Borg CR10 Scale
Participants' physical effort perception will be measured by The Borg CR10 Scale. After the IET application participants will answer the following question: "How much exertion did you experience during the test? ". This scale has 16 possible answers which vary from zero to 10 represented respectively from no effort to maximum effort.
Measured: Day 7
Effort Perception Scale
The effort perception will be evaluated by the Effort Perception Scale, with values between 0 and 10, 0 being correspondent to no effort at all (rest) and 10, to maximum effort
Measured: Day 1, day 2 and day 7
Recovery Perception Scale
The perceived recovery of the dominant lower limb will be assessed by means of the Effort Perception Scale, which consists of a 10-point Likert Scale, in which 1 means no recovery and 10, completely recovered
Measured: Day 1, day 2 and day 7
Heart Rate
The heart rate caption will take place using a cardio frequency meter (Polar electro, Oy Kempele, Finland - V800 model)
Measured: Day 2 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 Oct 2017
- Primary completion1 Jul 2018
- Study completion1 Sep 2018
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Larissa Rodrigues Souto, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Carlos Pastre, PhD, Principal investigator, Univ Estadual Paulista
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373747
- Sponsor's protocol ID
- 2016/11785-7
- Other IDs
- 2016
- Status last verified
- Mar 2019
- First submitted
- 21 Nov 2017
- Last updated
- 25 Mar 2019
- 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 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability Intra and Inter-evaluators and Physiological Analysis of an Isometric Test of Localized Muscular Fatigue
- ClinicalTrials.gov ID
- NCT03373747
- Acronym / sponsor ID
- 2016/11785-7
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 14 Dec 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 isokinetic dynamometer, considered a gold standard tool for physical evaluation, is widely used in studies that aim to evaluate the reliability and reproducibility of localized muscular endurance (LME) tests. However, such tests may not represent full LME by fixing time or number of replicates. Therefore, it is relevant to construct a test that respects the actual capacity of each subject to withstand fatigue and to submit such a test to validation, as well as to physiological analysis.
Research objectives: To assess the inter- and intra-rater reliability of a localized isometric endurance test (IET) on the isokinetic dynamometer and to establish the metabolic demand required during the test.
Design: Reliability study with test-reteste dynamic.
Participants and Setting: After fulfilling the eligibility criteria, eighty-eight male participants will participate in the study.
Procedure: In phase 1 forty-eight participants will submitted to reliability of the IET within three sessions: familiarization session, test session and retest sessio. In phase 2 forty participants will be submitted the metabolic demand required during the IET will be analyzed by means of gas analysis, blood lactat concetrate and muscular activation percentage.
Intervention: isometric endurance teste.
Measurements: The measurements include time of execution of test, work of test, physiological and psychological outcomes.
Detailed description
Introduction: The isokinetic dynamometer, considered a gold standard tool for physical evaluation, is widely used in studies that aim to evaluate the reliability and reproducibility of localized muscular endurance (LME) tests. However, such tests may not represent full LME by fixing time or number of replicates. Therefore, it is relevant to construct a test that respects the actual capacity of each subject to withstand fatigue and to submit such a test to validation, as well as to physiological analysis.
Research objectives: To assess the inter- and intra-rater reliability of a localized isometric endurance test (IET) on the isokinetic dynamometer and to establish the metabolic demand required during the test.
Design: Reliability study with test-reteste dynamic.
Participants and Setting: After fulfilling the eligibility criteria, eighty-eight male participants will participate in the study. The inclusion criteria include: healthy male, aged between 18-30 years who agree to participate in the study. Participants with the following will be excluded from the study: presence of anemia, inflammation, being sick, training or physical activity at least 24 hours prior the application of the test, being influenced in some way by test information, do not understand the teste and occurrence of musculoskeletal injury during the study.
Procedure: In phase 1 forty-eight participants will submitted to reliability of the IET within three sessions: familiarization session, test session and retest sessio. In phase 2 forty participants will be submitted the metabolic demand required during the IET will be analyzed by means of gas analysis, blood lactat concetrate and muscular activation percentage.
Intervention: This is a test that was developed by the Laboratory of Sports Physiotherapy of FCT/UNESP - Presidente Prudente. The test will be performed on the Biodex System Pro 4 isokinetic dynamometer (Biodex Medical System, Shirley-NY, USA). At first, participants will be be positioned and fixed on the device itself by their trunk, hips, thighs and by the distal region of the assessed lower limb (dominant). The protocol is composed by a 10 knee flexo-extension warm up at the speed of 330º/s, respecting the amplitude of 90º, then a 30 second isometric contraction from 50% to 60% of the maximum participant effort, according to the Effort Perception Scale. The test starts after two minutes of rest. So that it can take place, participants will be instructed to make as much effort as possible, according to the same scale, for as long as possible, until they can't keep muscle contraction no longer. To stimulate participants, evaluators will offer verbal motivation and they will follow a monitor, coupled to the device, which offers the power generation line which works as a visual feedback during all test long.
In phase 1, the first of familiarization is to the participants understand the test and familiarize with the equipment after 24 to 48 hours, the participants will do the test applied twice at the same day with 10 minutes of rest. For realization of the IET the participants will be instructe to make the maximum effort as possible and mantain until they can't resiste. After one week the retest session will be doing. The order between the evaluators will be changed in the test and retest sessions. In phase 2, the participants will be submitted two sessions, familiarization session and test session. In the test session there is be two teste applied in the same day with approximately 20 minutes of rest. In the first test, thers is gas analysis during all the test until seven minutes after the test and blood lactat concentrate will be colected before the test with 10 minutes of rest, immediately after the teste and in the first, in the third, fifth and seventh minutes after the test. In the second test will be assess the muscular activation porcentage of lateral vastus muscle by means of twitch interpolation technique there is be performe before and after the test.
Measurements: The measurements include time of execution of test (in seconds), work of test (in N.m), physiological (gas analysis, blood lactate concentration, muscular activation percentage) and psychological outcomes (Psychological Questionnaire, Work Ability Index Questionnaire, Perceived Stress Scale, The Bergen Insomnia Scale, Need for Recovery Scale, The Borg Scale, The Borg CR10 Scale, The Effort Perception Scale and Recovery Perception Scale) and clinical outcomes (heart rate).
Analysis: To analyse the normality will be used Shapiro Wilk test. For analysis of reliability test-retest will be used the intraclasse correlation coefficient (ICC), with confidence interval of 95% to reliability relative. To assess the reliability absolute the typical error and coefficient of variation will be done. The paired test t will be do to verify diferences n the mean of the groups. The psychological outcomes wiil be done with correlation and linear regression as well the physiologica outcomes. A significance level of 5% will be assumed for all statistical analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reliability of IET | Experimental | Diagnostic Test: Reliability of IETIn phase 1, the first of familiarization is to the participants understand the test and familiarize with the equipment after 24 to 48 hours, the participants will do the test applied twice at the same day with 10 minutes of rest. For realization of the IET the participants will be instructe to make the maximum effort as possible and mantain until they can't resiste. After one week the retest session will be doing. The order between the evaluators will be changed in the test and retest sessions. |
| Physiological analysis of IET | Experimental | Diagnostic Test: Physiological analysis of IETIn phase 2, the participants will be submitted two sessions, familiarization session and test session. In the test session there is be two teste applied in the same day with approximately 20 minutes of rest. In the first test, thers is gas analysis during all the test until seven minutes after the test and blood lactat concentrate will be colected before the test with 10 minutes of rest, immediately after the teste and in the first, in the third, fifth and seventh minutes after the test. In the second test will be assess the muscular activation porcentage of lateral vastus muscle by means of twitch interpolation technique there is be performe before and after the test. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy (self-report);
- Male gender;
- Aged between 18-30 years;
- Agreement to participate through signed statement of informed
Key exclusion criteria (7 listed)
- Being sick;
- Training or physical activity at least 24 hours priot to the application test;
- Being influenced in some way by test information;
- Do not understand the test;
- Inflammatory process;
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 |
|---|---|---|
| Reliability of IETThe participants will be do three sessions: familiarization, test and retest to assess the reliability inter and intra rater of the test. | Diagnostic test | Reliability of IET |
| Physiological analysis of IETThe participants will be submitted two sessions, familiarization session and test session. In the test session there will be the physiological analysis by means of gas analysis, blood lactate concentrate and activation muscular percentage. | Diagnostic test | Physiological analysis of IET |
Primary outcome
The time of execution of the test
Time frame: 45 seconds after the beginning of the test
This outcome will be assessed in seconds during execution of the test
14 secondary outcomes
The work of the test
Time frame: day 2 and day 7
Oxygen consumption - gas analysis
Time frame: Second phase during all the test
Blood lactate concentration
Time frame: Second phase, 10 minutes of rest before the test and immediately after the test and in the third, fifth and seven minutes after the test
Muscular activation percentage
Time frame: Day 2
Psychological Questionnaire
Time frame: Day 2 and day 7
Work Ability Index Questionnaire
Time frame: Day 1
Perceived Stress Scale
Time frame: Day 1
Bergen Insomnia Scale
Time frame: Day 1
Need for Recovery Scale
Time frame: Day 7
Borg Scale
Time frame: Day 7
Borg CR10 Scale
Time frame: Day 7
Effort Perception Scale
Time frame: Day 1, day 2 and day 7
Recovery Perception Scale
Time frame: Day 1, day 2 and day 7
Heart Rate
Time frame: Day 2 and day 7
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 25 Mar 2019.
- Individual participant dataSharing planned: No
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Screening Protocol
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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.
Carlos Pastre, PhD principal investigator
Univ Estadual Paulista
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reliability of IET and Physiological analysis of IET in people with Healthy Volunteers, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 2 sites 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 7 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 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The time of execution of the test (time frame: 45 seconds after the beginning of the test). 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 25 Mar 2019.