NCT02406339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

2.7 years

First QC Date

March 14, 2015

Last Update Submit

July 19, 2017

Conditions

Keywords

Physical TherapyRehabilitationNeuromuscular Electrical StimulationMuscle Strength

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Analysis of GH Level by blood test (mg / L)

    12 weeks

  • Analysis of IGF-1 Level by blood test (mg / L)

    12 weeks

  • Analysis of Star Excursion Balance Test (cm)

    12 weeks

  • Performance Analysis in Illinois agility test (Time in seconds)

    12 weeks

  • Muscle electromyographic analysis through the median frequency (Hz) and root mean square (RMS)

    12 weeks

Study Arms (3)

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.

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.

Device: NMESDevice: Vascular Occlusion

Interventions

NMESDEVICE

Neuromuscular Electrical Stimulation

ElectrotherapyElectrotherapy + Vascular Occlusion

Restriction of sanguine flow to the lower limbs

Electrotherapy + Vascular Occlusion

Eligibility Criteria

Age16 Years - 36 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rinaldo Roberto de Jesus Guirro

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 14, 2015

First Posted

April 2, 2015

Study Start

July 1, 2014

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations