NCT00512018

Brief Summary

The purpose of this study was to assess the effects of Neuromuscular Electrical Stimulation (NMES) associated to an isokinetic training program in both young healthy men and women. Twenty subjects (10 men, 10 women; 21±1.5 years) submitted both quadriceps femoris muscles to a strengthening program (3 sets of 10 isokinetic concentric repetitions at 30°/s) two days per week for 4 weeks. One limb was submitted only to the strength training (EX) while the other underwent the same training program but with NMES added to each contraction (Ex+NMES). The current used for NMES was Russian Current (frequency of 2500 Hz, 50 bursts/s and pulse duration of 200 µs). The evaluation protocol included isometric and isokinetic concentric extensor torques at 30°/s. Men increased their torque in both tested modalities in both limbs, with no difference between them. The angle of peak torque increased for the EX limb, showing an altered tension-length relationship, which did not occur for the Ex+NMES limb or for women. Women increased their torque for EX limb in both modalities, which only occured for isometric mode in the Ex+NMES limb. However, they showed a decrease in their acceleration time in Ex+NMES limbs, showing they could produce a muscular contraction more readily than they did before training. The results of this study found that the association between NMES and isokinetic concentric voluntary strength training does not improve strength gains of voluntary training itself for young healthy subjects of both genders. However, it could improve neuromuscular readiness to produce torque in women.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable healthy

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

January 1, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

1.9 years

First QC Date

August 3, 2007

Last Update Submit

April 17, 2013

Conditions

Keywords

Electric StimulationQuadriceps MuscleMuscle StrengthNeuromuscular PropertiesTension-Length RelationshipHealthy young adults

Outcome Measures

Primary Outcomes (1)

  • The association between NMES and isokinetic concentric voluntary strength training did not improve strength gains of voluntary training itself for young healthy subjects of both genders.

    Six months after stopping other type of strength training

Study Arms (2)

Isokinetic Exercise only

ACTIVE COMPARATOR

Individuals were asked to perform a 8-session training, twice a week, in which they trained the knee extensors muscles in an isokinetic dynamometer, 3 sets of 10 repetitions.

Other: Isokinetic exercise

Isokinetic exercise + NMES

EXPERIMENTAL

In the contralateral limb, the same protocol was repeated; however, each contraction was associated with overlapped NMES (Ex+NMES).

Device: NMES

Interventions

NMESDEVICE

In the contralateral limb, the same protocol was repeated; however, each contraction was associated with overlapped NMES (Ex+NMES limbs).For the NMES, a symmetric double-phase sine-wave was used. Bearing wave frequency was of 2500 Hz, modulated in 50 bursts/s, with pulse duration of 200 µs, interburst interval of 10 ms. This configuration is known as "Russian current".

Also known as: Current generator Physiotonus Slim (Bioset, Brazil)
Isokinetic exercise + NMES

Subjects realized training sessions twice a week with a 2-day minimum interval between the sessions, for 4 weeks. Each session included 5 min period of warm-up in a stationary bicycle, followed by 3 series of quadriceps stretching, as previously described. After being positioned at the isokinetic dynamometer, just as in the evaluation sessions, subjects firstly performed 3 sets of 10 maximum isokinetic concentric repetitions at the speed of 30º/s with one limb (EX limb), respecting the rest interval of 3 minutes between the sets.

Also known as: Isokinetic Dynamometer: Biodex Multi Joint System 3
Isokinetic Exercise only

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mariana A Avila, PT

    Universidade Federal de Sao Carlos

    PRINCIPAL INVESTIGATOR
  • Tania F Salvini, PhD

    Universidade Federal de Sao Carlos

    STUDY DIRECTOR
  • Jamilson S Brasileiro, PhD

    Universidade Federal do Rio Grande do Norte

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

August 3, 2007

First Posted

August 7, 2007

Study Start

January 1, 2005

Primary Completion

December 1, 2006

Study Completion

July 1, 2007

Last Updated

April 18, 2013

Record last verified: 2013-04