NCT03905772

Brief Summary

This study aims to evaluate on an acute session of the central and peripheral contributions of electrical stimulation on the muscle belly of the triceps surae, electrical stimulation of the tibial nerve and voluntary exercise of the triceps surae muscle, and identify responders individuals and non-responders to stimulation of the tibial nerve. Another objective of the study is to compare the effects of conventional electrical stimulation applied to the sciatic triceps muscle, tibial nerve stimulation and voluntary exercise after eight weeks of training in healthy individuals.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

April 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

March 11, 2019

Last Update Submit

May 23, 2023

Conditions

Keywords

Electrical stimulationM waveH reflexWide pulse

Outcome Measures

Primary Outcomes (6)

  • Change from Baseline Central contribution (H reflex) after 15 minutes of acute session of electrical stimulation.

    Central contribution will be measured before and after 15 minutes (36 contractions) of electrical stimulation in the acute session.

    Baseline and after 15 minutes of electrical stimulation in the acute session.

  • Change from Baseline Central contribution (H reflex) after 8 weeks of training with electrical stimulation.

    Central contribution will be measured before and after 8 weeks of training with electrical stimulation.

    Baseline and after 8 weeks of training with electrical stimulation.

  • Change from Baseline Peripheral contribution (M wave) after 15 minutes of acute session of electrical stimulation

    Peripheral contribution will be measured before and after acute session 15 minutes (36 contractions) of electrical stimulation in the acute session.

    Baseline and after 15 minutes of electrical stimulation in the acute session

  • Change from Baseline Peripheral contribution (M wave) after 8 weeks of traning with electrical atimulation

    Peripheral contribution will be measured before and after 8 weeks of training with electrical stimulation.

    Baseline and after 8 weeks of training with electrical stimulation

  • Change from Baseline Voluntary torque after 8 weeks of training with electrical stimulation

    Voluntary torque will be evaluated by an isokinetic dynamometer before and after an 8-week training period with electrical stimulation.

    Baseline and after 8 weeks of training with electrical stimulation

  • Change from Baseline Electromyographic signals after 8 weeks of training with electrical stimulation

    Electromyographic signals will be evaluated by an electromyography before and after an 8-week training period with electrical stimulation.

    Baseline and after 8 weeks of training with electrical stimulation

Secondary Outcomes (2)

  • Change from Baseline Evoked torque after 8 weeks of training with electrical stimulation

    Baseline and after 8 weeks of training with electrical stimulation

  • Change from Baseline Discomfort sensory after 8 weeks of training with electrical stimulation

    Baseline and after 8 weeks of training with electrical stimulation

Study Arms (4)

Voluntary exercise

EXPERIMENTAL

The participants will perform 36 voluntary contractions of 20% of maximal voluntary isometrical contraction, 3 times per week for 8 weeks.

Other: Voluntary exercise

Wide pulse responder group

EXPERIMENTAL

The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. This group will classified in responder in the acute fase.

Other: Wide pulse responder group

Wide pulse non responder group

EXPERIMENTAL

The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. This group will classified in non responder in the acute fase.

Other: Wide pulse non responder group

Pulsed current group

EXPERIMENTAL

The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 250 μs, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks.

Other: Pulsed current group

Interventions

The participants will perform 36 maximal voluntary contractions, 3 times per week for 8 weeks.

Voluntary exercise

The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. This group will be classified in responder group in acute fase.

Wide pulse responder group

The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. This group will be classified in non responder group in acute fase.

Wide pulse non responder group

The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 250 μs, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks.

Pulsed current group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Classified as physically active according to the INTERNATIONAL QUESTIONNAIRE OF PHYSICAL ACTIVITY,
  • To practice only recreational physical activity,
  • Achieve minimum torque of 30% of the (maximal voluntary isometric contraction during conventional NMES
  • Be at least 3 months without practicing strength training.

You may not qualify if:

  • Present some type of skeletal muscle dysfunction that may interfere with the tests,
  • Present intolerance to NMES in the muscular or tibial nerve, Make use of analgesics, antidepressants, tranquillizers or other agents of central action
  • To present cardiovascular or peripheral vascular problems, chronic diseases, neurological or muscular affections that will undermine the complete execution of the study design by the volunteer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Ceilandia UnB

BrasĂ­lia, Federal District, 72220-275, Brazil

Location

Related Publications (41)

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  • Binder-Macleod SA, Halden EE, Jungles KA. Effects of stimulation intensity on the physiological responses of human motor units. Med Sci Sports Exerc. 1995 Apr;27(4):556-65.

  • Gorgey AS, Black CD, Elder CP, Dudley GA. Effects of electrical stimulation parameters on fatigue in skeletal muscle. J Orthop Sports Phys Ther. 2009 Sep;39(9):684-92. doi: 10.2519/jospt.2009.3045.

  • Gorgey AS, Dudley GA. The role of pulse duration and stimulation duration in maximizing the normalized torque during neuromuscular electrical stimulation. J Orthop Sports Phys Ther. 2008 Aug;38(8):508-16. doi: 10.2519/jospt.2008.2734. Epub 2008 Aug 1.

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  • Ward AR, Oliver WG, Buccella D. Wrist extensor torque production and discomfort associated with low-frequency and burst-modulated kilohertz-frequency currents. Phys Ther. 2006 Oct;86(10):1360-7. doi: 10.2522/ptj.20050300.

  • Laufer Y, Elboim M. Effect of burst frequency and duration of kilohertz-frequency alternating currents and of low-frequency pulsed currents on strength of contraction, muscle fatigue, and perceived discomfort. Phys Ther. 2008 Oct;88(10):1167-76. doi: 10.2522/ptj.20080001. Epub 2008 Aug 14.

  • Dantas LO, Vieira A, Siqueira AL Jr, Salvini TF, Durigan JL. Comparison between the effects of 4 different electrical stimulation current waveforms on isometric knee extension torque and perceived discomfort in healthy women. Muscle Nerve. 2015 Jan;51(1):76-82. doi: 10.1002/mus.24280.

  • Bergquist AJ, Wiest MJ, Collins DF. Motor unit recruitment when neuromuscular electrical stimulation is applied over a nerve trunk compared with a muscle belly: quadriceps femoris. J Appl Physiol (1985). 2012 Jul;113(1):78-89. doi: 10.1152/japplphysiol.00074.2011. Epub 2012 May 3.

  • Maffiuletti NA. Physiological and methodological considerations for the use of neuromuscular electrical stimulation. Eur J Appl Physiol. 2010 Sep;110(2):223-34. doi: 10.1007/s00421-010-1502-y. Epub 2010 May 15.

  • Barss TS, Ainsley EN, Claveria-Gonzalez FC, Luu MJ, Miller DJ, Wiest MJ, Collins DF. Utilizing Physiological Principles of Motor Unit Recruitment to Reduce Fatigability of Electrically-Evoked Contractions: A Narrative Review. Arch Phys Med Rehabil. 2018 Apr;99(4):779-791. doi: 10.1016/j.apmr.2017.08.478. Epub 2017 Sep 19.

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Study Officials

  • JoĂ£o Durigan, PhD

    University of Brasilia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist Assistant Professor

Study Record Dates

First Submitted

March 11, 2019

First Posted

April 5, 2019

Study Start

April 15, 2019

Primary Completion

May 1, 2020

Study Completion

December 1, 2023

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations