Muscle Strength Quantitative Trait Locus 1NCT02764840
Muscular Resistance Test in the Elastic Tube: Reliability and Training of the Proposed Method
A study testing isokinetic dynamometer and elastic tube in people with Muscle Strength Quantitative Trait Locus 1, run by São Paulo State University at 1 site in Brazil.
Trial 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. 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
- Muscle Strength Quantitative Trait Locus 1
- What is being tested?
- isokinetic dynamometer and elastic tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Feb 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 young and physically active
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- isokinetic dynamometer, elastic tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isokinetic dynamometerOther
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.
elastic tubeOther
In the first stage a fatigue test will be applied. In the second stage, different participants will undergo a protocol for muscle strength gain.
| Study group | Role | What they receive |
|---|---|---|
| experimental group isokinetic dynamometer (GEDI) | Experimental | Isokinetic Biodex System Pro 4 Receives: Other: isokinetic dynamometer |
| experimental group elastic tube (GETE) | Experimental | elastic tube brand LEMGRUBER 203 Receives: Other: elastic tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to four weeks
Secondary outcomes (1)
measure the gain endurance and strength
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
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Strength Quantitative Trait Locus 1Studies 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
- Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaqueline Santos Silva, São Paulo State University
- Investigators
- Jaqueline Silva, student, Principal investigator, São Paulo State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764840
- Sponsor's protocol ID
- SaoPSU
- Status last verified
- Apr 2017
- First submitted
- 2 Dec 2015
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscular Resistance Test in the Elastic Tube: Reliability and Training of the Proposed Method
- ClinicalTrials.gov ID
- NCT02764840
- Acronym / sponsor ID
- SaoPSU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 6 May 2016 (estimated)
- 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group isokinetic dynamometer (GEDI) | Experimental | Other: isokinetic dynamometerIsokinetic Biodex System Pro 4 |
| experimental group elastic tube (GETE) | Experimental | Other: elastic tubeelastic tube brand LEMGRUBER 203 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy young and physically active
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| isokinetic dynamometerIn 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. | Other | experimental group isokinetic dynamometer (GEDI) |
| elastic tubeIn the first stage a fatigue test will be applied. In the second stage, different participants will undergo a protocol for muscle strength gain. | Other | experimental group elastic tube (GETE) |
Primary outcome
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
1 secondary outcome
measure the gain endurance and strength
Time frame: up to four weeks
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 Apr 2017.
- Individual participant dataSharing planned: Yes
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.
Jaqueline Silva, student principal investigator
São Paulo State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isokinetic dynamometer and elastic tube in people with Muscle Strength Quantitative Trait Locus 1, 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 1 inclusion and 1 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 Apr 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?
Reliability of the proposed test (time frame: up to four weeks). 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 Apr 2017.