Electric Stimulation TherapyNCT02406339
Effectiveness of NMES Associated to Vascular Occlusion in Functional Performance and Muscle Hypertrophy in Athlete's
A study testing NMES and Vascular Occlusion in people with Electric Stimulation Therapy and Muscle Strength, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study evaluates the effect of training with neuromuscular electrical stimulation (NMES) associated with vascular occlusion of the lower limbs, for increased strength and hypertrophy of the quadriceps muscle of professional basketball athletes. Read more about this study
- Who is it for?
- Ages 16 to 36 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Electric Stimulation Therapy, Muscle Strength
- What is being tested?
- NMES and Vascular Occlusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to May 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 16 to 36 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The categories Basketball Athletes sub- 19, 21 and professional
- BMI between 20 and 24 kg / m²;
- To present physical and cardiorespiratory fitness, attested by the medical responsible for the team, for conducting evaluations and physical training;
Who cannot join
- Previous disease of circulatory order, nervous, metabolic, rheumatic and orthopedic; history of pain or muscle or joint injuries in the lower limbs in the last three months; subjects suffering from muscle fatigue complaint at the time of testing; athletes require the use of stabilizers to perform the tests;
- To present ankle instability assessed by questionnaire Foot and Ankle Outcome Score
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Rinaldo Roberto de Jesus Guirro
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Analysis of the Effectiveness of Neuromuscular Electrical Stimulation Associated to Vascular Occlusion in Functional Performance and Muscle Hypertrophy in Athlete's Basketball of High Performance. Blind Randomized Clinical Trial
This study evaluates the effect of training with neuromuscular electrical stimulation (NMES) associated with vascular occlusion of the lower limbs, for increased strength and hypertrophy of the quadriceps muscle of professional basketball athletes.
Read the detailed description
The pre-season preparation is seen as vital to maximize sports performance. However, there has been much debate on what the best strategy to prepare for use. Basketball is a sports activity of high intensity and volume of jumps, which are generally likely to cause injuries resulting from muscle imbalance and dynamic overload. Primarily in activities with eccentric contraction of the knee extensor muscles. A means of preventing injuries and optimization of sports performance is through strength training. Neuromuscular electrical stimulation (NMES) has been a physical therapy effective in increasing the recruitment of muscle fibers and strength. Another method that has been shown effective in increasing strength and muscle hypertrophy is the association of low intensity training and peripheral vascular occlusion. Therefore, the purpose of this study is to evaluate the effectiveness of neuromuscular electrical stimulation associated to vascular occlusion of lower limb muscle recruitment, strength and muscle hypertrophy. This will be met recruited basketball athletes of high performance, the males, aged between 18 and 30 years and BMI between 20 and 24 Kg/m2. The athletes will be randomized into four groups: group control (n = 15), group electrotherapy (n = 15) and group electrotherapy + vascular occlusion (n = 15). Will be carried out 12 sessions of treatment during the pre-season, and the volunteers evaluated before and after the pre-season and in middle the season, through the following instruments: Isokinetic Dynamometer, Surface Electromyography, Force Platform, Cross Section Area of Muscle, Vertical Jump, Functional Evaluation (Jump, Agility and Balance), Infrared Thermography and Numeric Scale of Pain Evaluation. For data analysis, normality test is used to verify the data distribution and consistent statistical test for the appropriate comparisons within and between groups, and thus considered two factors in the comparisons, time and group. Will adopt a significance level of 5%.
- Conditions
- Electric Stimulation Therapy, Muscle Strength
- Being tested
- NMES, Vascular Occlusion
- Keywords
- Physical Therapy, Rehabilitation, Neuromuscular Electrical Stimulation, Muscle Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESDevice
Neuromuscular Electrical Stimulation
Vascular OcclusionDevice
Restriction of sanguine flow to the lower limbs
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Are not subject to any intervention. |
| Electrotherapy | Experimental | The athletes will be submitted to NMES of bilateral quadriceps. The stimulation will be held in order to induce the move flexion / extension involuntary knee in extension machine, with resistance of 30% of maximum voluntary strength. Receives: Device: NMES |
| Electrotherapy + Vascular Occlusion | Experimental | The same as in Electrotherapy group, athletes are subjected to NMES associated total vascular occlusion of the members below the level of the groin. Receives: Device: NMES; Device: Vascular Occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of muscle strength through isokinetic dynamometer (N / M).
The association of NMES and vascular occlusion of the lower limbs increases the isokinetic torque?
Measured: 12 weeks
Analysis of hypertrophy through the cross section area of the muscle via ultrasound (mm).
The association of NMES and vascular occlusion of the lower limbs increases the cross-sectional area of the muscle?
Measured: 12 weeks
Secondary outcomes (5)
Analysis of GH Level by blood test (mg / L)
The association of NMES and vascular occlusion of the lower limbs increases the growth hormone (GH) levels after training?
Measured: 12 weeks
Analysis of IGF-1 Level by blood test (mg / L)
The association of NMES and vascular occlusion of the lower limbs increases the insulin like growth factor-1 (IGF-1) after training?
Measured: 12 weeks
Analysis of Star Excursion Balance Test (cm)
The association of NMES and vascular occlusion of the lower limbs improves balance of the athletes?
Measured: 12 weeks
Performance Analysis in Illinois agility test (Time in seconds)
The association of NMES and vascular occlusion of the lower limbs improves agility of the athletes?
Measured: 12 weeks
Muscle electromyographic analysis through the median frequency (Hz) and root mean square (RMS)
The association of NMES and vascular occlusion of the lower limbs increases the muscle activation and recruitment?
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionMar 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electric Stimulation TherapyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406339
- Sponsor's protocol ID
- U1111-1143
- Status last verified
- Jul 2017
- First submitted
- 14 Mar 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effectiveness of Neuromuscular Electrical Stimulation Associated to Vascular Occlusion in Functional Performance and Muscle Hypertrophy in Athlete's Basketball of High Performance. Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02406339
- Acronym / sponsor ID
- U1111-1143
- Conditions
- Electric Stimulation Therapy, Muscle Strength
- Keywords
- Physical Therapy, Rehabilitation, Neuromuscular Electrical Stimulation, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 2 Apr 2015 (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.
This study evaluates the effect of training with neuromuscular electrical stimulation (NMES) associated with vascular occlusion of the lower limbs, for increased strength and hypertrophy of the quadriceps muscle of professional basketball athletes.
Detailed description
The pre-season preparation is seen as vital to maximize sports performance. However, there has been much debate on what the best strategy to prepare for use. Basketball is a sports activity of high intensity and volume of jumps, which are generally likely to cause injuries resulting from muscle imbalance and dynamic overload. Primarily in activities with eccentric contraction of the knee extensor muscles. A means of preventing injuries and optimization of sports performance is through strength training. Neuromuscular electrical stimulation (NMES) has been a physical therapy effective in increasing the recruitment of muscle fibers and strength. Another method that has been shown effective in increasing strength and muscle hypertrophy is the association of low intensity training and peripheral vascular occlusion. Therefore, the purpose of this study is to evaluate the effectiveness of neuromuscular electrical stimulation associated to vascular occlusion of lower limb muscle recruitment, strength and muscle hypertrophy. This will be met recruited basketball athletes of high performance, the males, aged between 18 and 30 years and BMI between 20 and 24 Kg/m2. The athletes will be randomized into four groups: group control (n = 15), group electrotherapy (n = 15) and group electrotherapy + vascular occlusion (n = 15). Will be carried out 12 sessions of treatment during the pre-season, and the volunteers evaluated before and after the pre-season and in middle the season, through the following instruments: Isokinetic Dynamometer, Surface Electromyography, Force Platform, Cross Section Area of Muscle, Vertical Jump, Functional Evaluation (Jump, Agility and Balance), Infrared Thermography and Numeric Scale of Pain Evaluation. For data analysis, normality test is used to verify the data distribution and consistent statistical test for the appropriate comparisons within and between groups, and thus considered two factors in the comparisons, time and group. Will adopt a significance level of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Are not subject to any intervention. |
| Electrotherapy | Experimental | Device: NMESThe athletes will be submitted to NMES of bilateral quadriceps. The stimulation will be held in order to induce the move flexion / extension involuntary knee in extension machine, with resistance of 30% of maximum voluntary strength. |
| Electrotherapy + Vascular Occlusion | Experimental | Device: NMES, Device: Vascular OcclusionThe same as in Electrotherapy group, athletes are subjected to NMES associated total vascular occlusion of the members below the level of the groin. |
Who may qualify
- Ages
- 16 to 36 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- The categories Basketball Athletes sub- 19, 21 and professional
- BMI between 20 and 24 kg / m²;
- To present physical and cardiorespiratory fitness, attested by the medical responsible for the team, for conducting evaluations and physical training;
Key exclusion criteria (2 listed)
- Previous disease of circulatory order, nervous, metabolic, rheumatic and orthopedic; history of pain or muscle or joint injuries in the lower limbs in the last three months; subjects suffering from muscle fatigue complaint at the time of testing; athletes require the use of stabilizers to perform the tests;
- To present ankle instability assessed by questionnaire Foot and Ankle Outcome Score
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 |
|---|---|---|
| NMESNeuromuscular Electrical Stimulation | Device | Electrotherapy, Electrotherapy + Vascular Occlusion |
| Vascular OcclusionRestriction of sanguine flow to the lower limbs | Device | Electrotherapy + Vascular Occlusion |
Primary outcome
Analysis of muscle strength through isokinetic dynamometer (N / M).
Time frame: 12 weeks
The association of NMES and vascular occlusion of the lower limbs increases the isokinetic torque?
Analysis of hypertrophy through the cross section area of the muscle via ultrasound (mm).
Time frame: 12 weeks
The association of NMES and vascular occlusion of the lower limbs increases the cross-sectional area of the muscle?
5 secondary outcomes
Analysis of GH Level by blood test (mg / L)
Time frame: 12 weeks
Analysis of IGF-1 Level by blood test (mg / L)
Time frame: 12 weeks
Analysis of Star Excursion Balance Test (cm)
Time frame: 12 weeks
Performance Analysis in Illinois agility test (Time in seconds)
Time frame: 12 weeks
Muscle electromyographic analysis through the median frequency (Hz) and root mean square (RMS)
Time frame: 12 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 21 Jul 2017.
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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.
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 NMES and Vascular Occlusion in people with Electric Stimulation Therapy and Muscle Strength, run by University of Sao Paulo 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 3 inclusion and 2 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 21 Jul 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?
Analysis of muscle strength through isokinetic dynamometer (N / M). (time frame: 12 weeks). 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 21 Jul 2017.