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Effectiveness of NMES Associated to Vascular Occlusion in Functional Performance and Muscle Hypertrophy in Athlete's

Primary Purpose

Electric Stimulation Therapy, Muscle Strength

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
NMES
Vascular Occlusion
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Electric Stimulation Therapy focused on measuring Physical Therapy, Rehabilitation, Neuromuscular Electrical Stimulation, Muscle Strength

Eligibility Criteria

16 Years - 36 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Rinaldo Roberto de Jesus Guirro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Electrotherapy

Electrotherapy + Vascular Occlusion

Arm Description

Are not subject to any intervention.

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.

The same as in Electrotherapy group, athletes are subjected to NMES associated total vascular occlusion of the members below the level of the groin.

Outcomes

Primary Outcome Measures

Analysis of muscle strength through isokinetic dynamometer (N / M).
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).
The association of NMES and vascular occlusion of the lower limbs increases the cross-sectional area of the muscle?

Secondary Outcome Measures

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?
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?
Analysis of Star Excursion Balance Test (cm)
The association of NMES and vascular occlusion of the lower limbs improves balance of the athletes?
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?
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?

Full Information

First Posted
March 14, 2015
Last Updated
July 19, 2017
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02406339
Brief Title
Effectiveness of NMES Associated to Vascular Occlusion in Functional Performance and Muscle Hypertrophy in Athlete's
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electric Stimulation Therapy, Muscle Strength
Keywords
Physical Therapy, Rehabilitation, Neuromuscular Electrical Stimulation, Muscle Strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Are not subject to any intervention.
Arm Title
Electrotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Electrotherapy + Vascular Occlusion
Arm Type
Experimental
Arm Description
The same as in Electrotherapy group, athletes are subjected to NMES associated total vascular occlusion of the members below the level of the groin.
Intervention Type
Device
Intervention Name(s)
NMES
Intervention Description
Neuromuscular Electrical Stimulation
Intervention Type
Device
Intervention Name(s)
Vascular Occlusion
Intervention Description
Restriction of sanguine flow to the lower limbs
Primary Outcome Measure Information:
Title
Analysis of muscle strength through isokinetic dynamometer (N / M).
Description
The association of NMES and vascular occlusion of the lower limbs increases the isokinetic torque?
Time Frame
12 weeks
Title
Analysis of hypertrophy through the cross section area of the muscle via ultrasound (mm).
Description
The association of NMES and vascular occlusion of the lower limbs increases the cross-sectional area of the muscle?
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Analysis of GH Level by blood test (mg / L)
Description
The association of NMES and vascular occlusion of the lower limbs increases the growth hormone (GH) levels after training?
Time Frame
12 weeks
Title
Analysis of IGF-1 Level by blood test (mg / L)
Description
The association of NMES and vascular occlusion of the lower limbs increases the insulin like growth factor-1 (IGF-1) after training?
Time Frame
12 weeks
Title
Analysis of Star Excursion Balance Test (cm)
Description
The association of NMES and vascular occlusion of the lower limbs improves balance of the athletes?
Time Frame
12 weeks
Title
Performance Analysis in Illinois agility test (Time in seconds)
Description
The association of NMES and vascular occlusion of the lower limbs improves agility of the athletes?
Time Frame
12 weeks
Title
Muscle electromyographic analysis through the median frequency (Hz) and root mean square (RMS)
Description
The association of NMES and vascular occlusion of the lower limbs increases the muscle activation and recruitment?
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Rinaldo Roberto de Jesus Guirro
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

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Effectiveness of NMES Associated to Vascular Occlusion in Functional Performance and Muscle Hypertrophy in Athlete's

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