Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuromuscular Adaptations After Training in the Muscle Belly of Triceps Surae

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03905772
Recruitment Status : Unknown
Verified March 2019 by João Luiz Q. Durigan, University of Brasilia.
Recruitment status was:  Not yet recruiting
First Posted : April 5, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
University of Burgundy
Information provided by (Responsible Party):
João Luiz Q. Durigan, University of Brasilia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Electrical Stimulation Other: Voluntary exercise Other: Wide pulse responder group Other: Wide pulse non responder group Other: Pulsed current group Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuromuscular Adaptations After Training With Neuromuscular Electrical Stimulation Applied Over Nerve Trunk Compared With a Muscle Belly of Triceps Surae: Randomized Controlled Trial
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : December 1, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905772


Contacts
Layout table for location contacts
Contact: Karenina G Modesto, Ms +5561982030936 kareninag.87@gmail.com
Contact: João Durigan, PhD 5561981408621 joaodurigan@gmail.com

Sponsors and Collaborators
University of Brasilia
University of Burgundy
Investigators
Layout table for investigator information
Study Director: João Durigan, PhD University of Brasilia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: João Luiz Q. Durigan, Physical Therapist Assistant Professor, University of Brasilia
ClinicalTrials.gov Identifier: NCT03905772    
Other Study ID Numbers: 01326818.8.0000.8093
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by João Luiz Q. Durigan, University of Brasilia:
Electrical stimulation
M wave
H reflex
Wide pulse