Neuromuscular Adaptations After Training in the Muscle Belly of Triceps Surae

May 23, 2023 updated by: João Luiz Q. Durigan, University of Brasilia

Neuromuscular Adaptations After Training With Neuromuscular Electrical Stimulation Applied Over Nerve Trunk Compared With a Muscle Belly of Triceps Surae: Randomized Controlled Trial

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

A controlled randomized controlled trial will be carried out by university students, divided equally into four groups: control group (GC), long responding pulse group (PLR), non-responder long pulse group (PLNR) and pulsed current group (CP) after the acute fase of the protocol. Muscular architecture (muscle thickness, pennation angle and fascicle length) of the muscles composing the sural triceps, H-reflex and M-wave tests (central and peripheral contribution), electromyographic signals of the medial and lateral gastrocnemius muscles and sole, voluntary and evoked joint torque of the muscles composing the sural triceps and level of sensorial discomfort. The independent intervention with the neuromuscular electrical stimulation and the isometric exercises performed by the control group will be considered as an independent variable. All groups will have the dependent variables evaluated 6 times, before, during and after the intervention, which will consist of 24 sessions (8 weeks). The training with neuromuscular electrical stimulation (NMES) will be performed 3 times a week and will never be applied for two consecutive days, as well as the voluntary exercises performed by the control group.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • DF
      • Brasília, DF, Brazil, 72220-275
        • Faculty of Ceilandia UnB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Voluntary exercise
The participants will perform 36 voluntary contractions of 20% of maximal voluntary isometrical contraction, 3 times per week for 8 weeks.
Other: Voluntary exercise
The participants will perform 36 maximal voluntary contractions, 3 times per week for 8 weeks.
Experimental: 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 classified in responder in the acute fase.
Other: 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 responder group in acute fase.
Experimental: Wide pulse non 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 classified in non responder in the acute fase.
Other: Wide pulse non 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.
Experimental: Pulsed current 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.
Other: Pulsed current 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Central contribution (H reflex) after 15 minutes of acute session of electrical stimulation.
Time Frame: Baseline and after 15 minutes of electrical stimulation in the acute session.
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.
Time Frame: Baseline and 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
Time Frame: Baseline and after 15 minutes of electrical stimulation in the acute session
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
Time Frame: Baseline and after 8 weeks of training with electrical stimulation
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
Time Frame: Baseline and 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
Time Frame: Baseline and 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Evoked torque after 8 weeks of training with electrical stimulation
Time Frame: Baseline and after 8 weeks of training with electrical stimulation
Evoked 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 Discomfort sensory after 8 weeks of training with electrical stimulation
Time Frame: Baseline and after 8 weeks of training with electrical stimulation
Discomfort sensory will be evaluated by Visual Analogic Scale before and after an 8-week training period with electrical stimulation. The Visual Analogic Scale assess pain by rating the subjective perceived disconfort of the subject from 0 (no pain) to 10 (unbearable pain)
Baseline and after 8 weeks of training with electrical stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Collaborators

University of Burgundy

Investigators

  • Study Director: João Durigan, PhD, University of Brasilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Actual)

May 1, 2020

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 5, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 01326818.8.0000.8093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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