CClinicalTrials.gg
CompletedNCT02406339Updated Jul 21, 2017

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

An interventional study of NMES and Vascular Occlusion in Electric Stimulation Therapy and Muscle Strength, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to male participants aged 16 Years to 36 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-21.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2014, registered Mar 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
16 Years to 36 Years
Sex
Male
01

Study 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 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%.

02

Conditions studied

  • Electric Stimulation Therapy
  • Muscle Strength

Browse trials for

Keywords

  • Physical Therapy
  • Rehabilitation
  • Neuromuscular Electrical Stimulation
  • Muscle Strength
03

In context

Hypertrophy

656 studies on the registry are indexed under Hypertrophy; 87 are open to participants now.

This study's enrollment of 45 is close to the median of 50 across 460 interventional studies indexed under Hypertrophy.

Browse Hypertrophy studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 36 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
45 participants (actual)

Study arms

  • 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.

    Device: NMES

  • 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.

    Device: NMES · Device: Vascular Occlusion

Interventions

  • DeviceNMES

    Neuromuscular Electrical Stimulation

  • DeviceVascular Occlusion

    Restriction of sanguine flow to the lower limbs

06

What researchers measure

Primary outcomes

  1. Analysis of muscle strength through isokinetic dynamometer (N / M).

    The association of NMES and vascular occlusion of the lower limbs increases the isokinetic torque?

    Time frame: 12 weeks

  2. 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?

    Time frame: 12 weeks

Secondary outcomes

  1. 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?

    Time frame: 12 weeks

  2. 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?

    Time frame: 12 weeks

  3. Analysis of Star Excursion Balance Test (cm)

    The association of NMES and vascular occlusion of the lower limbs improves balance of the athletes?

    Time frame: 12 weeks

  4. 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?

    Time frame: 12 weeks

  5. 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?

    Time frame: 12 weeks

07

Study locations

1 site
  • Rinaldo Roberto de Jesus Guirro
    Ribeirão Preto, São Paulo 14049-900, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02406339
Lead sponsor
University of Sao Paulo
Responsible party
Rinaldo Roberto de Jesus Guirro (PhD, University of Sao Paulo) — Principal investigator
First posted
Apr 2, 2015
Start date
Jul 2014
Primary completion
Mar 2017
Completion
May 2017
Last update
Jul 21, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion