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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02406339
Other study ID # U1111-1143
Secondary ID
Status Completed
Phase N/A
First received March 14, 2015
Last updated July 19, 2017
Start date July 2014
Est. completion date May 2017

Study information

Verified date July 2017
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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%.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date May 2017
Est. primary completion date March 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 16 Years to 36 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
NMES
Neuromuscular Electrical Stimulation
Vascular Occlusion
Restriction of sanguine flow to the lower limbs

Locations

Country Name City State
Brazil Rinaldo Roberto de Jesus Guirro Ribeirão Preto São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Analysis of muscle strength through isokinetic dynamometer (N / M). The association of NMES and vascular occlusion of the lower limbs increases the isokinetic torque? 12 weeks
Primary 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? 12 weeks
Secondary 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? 12 weeks
Secondary 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? 12 weeks
Secondary Analysis of Star Excursion Balance Test (cm) The association of NMES and vascular occlusion of the lower limbs improves balance of the athletes? 12 weeks
Secondary 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? 12 weeks
Secondary 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? 12 weeks
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