- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02406339
Effectiveness of NMES Associated to Vascular Occlusion in Functional Performance and Muscle Hypertrophy in Athlete's
July 19, 2017 updated by: Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
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Ribeirão Preto, São Paulo, Brazil, 14049-900
- Rinaldo Roberto de Jesus Guirro
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 36 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Are not subject to any intervention.
|
|
|
Experimental: Electrotherapy
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.
|
Neuromuscular Electrical Stimulation
|
|
Experimental: Electrotherapy + Vascular Occlusion
The same as in Electrotherapy group, athletes are subjected to NMES associated total vascular occlusion of the members below the level of the groin.
|
Neuromuscular Electrical Stimulation
Restriction of sanguine flow to the lower limbs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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?
|
12 weeks
|
|
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?
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analysis of GH Level by blood test (mg / L)
Time Frame: 12 weeks
|
The association of NMES and vascular occlusion of the lower limbs increases the growth hormone (GH) levels after training?
|
12 weeks
|
|
Analysis of IGF-1 Level by blood test (mg / L)
Time Frame: 12 weeks
|
The association of NMES and vascular occlusion of the lower limbs increases the insulin like growth factor-1 (IGF-1) after training?
|
12 weeks
|
|
Analysis of Star Excursion Balance Test (cm)
Time Frame: 12 weeks
|
The association of NMES and vascular occlusion of the lower limbs improves balance of the athletes?
|
12 weeks
|
|
Performance Analysis in Illinois agility test (Time in seconds)
Time Frame: 12 weeks
|
The association of NMES and vascular occlusion of the lower limbs improves agility of the athletes?
|
12 weeks
|
|
Muscle electromyographic analysis through the median frequency (Hz) and root mean square (RMS)
Time Frame: 12 weeks
|
The association of NMES and vascular occlusion of the lower limbs increases the muscle activation and recruitment?
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2014
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
March 14, 2015
First Submitted That Met QC Criteria
March 29, 2015
First Posted (Estimate)
April 2, 2015
Study Record Updates
Last Update Posted (Actual)
July 21, 2017
Last Update Submitted That Met QC Criteria
July 19, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1143
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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