NCT05061056

Brief Summary

Neuromuscular Electrical Stimulation (NMES) can minimize muscle atrophy, complications related to muscle disuse and improved neuromuscular performance. However, it is still unclear the influence of specific physical parameters, including carrier frequency, burst duration, and duty cycle regarding the greater generation of evoked torque, sensory discomfort, muscle fatigue, and peripheral oxygen extraction. Thus, the aim of this study is to compare the effects of different NMES protocols applied to the triceps surae muscle for evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction in healthy individuals. This is a crossover, experimental, randomized, double-blind trial composed of apparently healthy participants. All NMES protocols will be tested on the same individual with randomization of the sequence of intervention protocols. There will be a total of 6 encounters with seven days between them. Session 1 will evaluate the anthropometric measures, the maximum intensity for each intervention protocol, and the sequence of intervention protocols for each individual will be randomized. Sessions 2, 3, 4, and 5 will be composed equally with the assessment of the maximum voluntary and evoked joint torque of the triceps surae muscle through the isokinetic dynamometer, evaluation of muscle fatigue through the H-reflex, M-wave, fatigue index, time-torque-integral, and recruitment curve, evaluation of peripheral oxygen extraction through NIRS (Near Infrared Spectroscopy), electromyographic signals to assessed the RMS (root mean square) and the median frequency, evaluation of the level of sensory discomfort through the Visual Analog Pain Scale and finally by the NMES protocol. The 6th session will be the replication of the 2nd session of each individual. The EENM protocols will be as follows: CR10% (Russian Current with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts), CR20% (Russian Current with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 20% of duty cycle - 4 ms bursts and 16 ms interbusrts), CA10% (Aussie current with 1000 Hz, modulated in bursts of 50 Hz, 500 µs and 10% duty cycle - 2 ms of bursts and 18 ms interbusrts), CA20% (Aussie current with 1000 Hz, modulated in bursts of 50 Hz, 500 µs and 20% of duty cycle - 4 ms of bursts and 16 ms interbusrts) all protocols will be performed on the triceps surae muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 2, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2022

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

September 9, 2021

Last Update Submit

May 23, 2023

Conditions

Keywords

Healthy YoungElectric Stimulation TherapyEvoked torqueSensory discomfortPeripheral oxygen extraction

Outcome Measures

Primary Outcomes (9)

  • Submaximal voluntary isometric contraction of the triceps surae

    Expressed in muscle strength, assessed using an isokinetic dynamometer

    2 minutes

  • Maximum voluntary isometric contraction of the triceps surae

    Expressed in muscle strength, assessed using an isokinetic dynamometer

    5 minutes

  • Maximum evoked torque

    Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer

    5 minutes

  • Torque evoked during the fatigue protocol

    Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer

    20 minutes

  • Peripheral oxygen extraction

    Expressed by peripheral oxygen consumption assessed by near-infrared spectroscopy from the beginning to the end of the sessions

    40 minutes

  • Muscle fatigue assessment before the muscle fatigue protocol

    Expressed by mechanical properties of plantar flexors and central activation relationship using the contraction interpolation technique

    10 minutes

  • Assessment of muscle fatigue during the muscle fatigue protocol

    Expressed by the muscle fatigue index through the decline in torque evoked from the beginning to the end of the protocol

    20 minutes

  • Muscle fatigue assessment during the muscle fatigue protocol

    Expressed by the decline in torque-time-integral from the beginning to the end of the protocol

    20 minutes

  • Electromyographic signals

    Expressed by the raw values of RMS and Median Frequency within a range of 500 ms throughout the entire session

    40 minutes

Secondary Outcomes (2)

  • Sensory discomfort during maximum evoked torques

    10 seconds

  • Sensory discomfort during fatigue protocol

    10 seconds

Study Arms (4)

Russian current 10%

EXPERIMENTAL

Subjects will receive a interventions (Russian Current at 10% duty cycle). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated.

Other: Russian current 10%

Russian current 20%

EXPERIMENTAL

Subjects will receive a interventions (Russian Current at 20% duty cycle). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated.

Other: Russian current 20%

Aussie current 10%

EXPERIMENTAL

Subjects will receive a interventions (Aussie Current at 10% duty cycle). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated.

Other: Aussie current 10%

Aussie current 20%

EXPERIMENTAL

Subjects will receive a interventions (Aussie Current at 20% duty cycle). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated.

Other: Aussie current 20%

Interventions

Russian current with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts

Russian current 10%

Russian current with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 20% duty cycle - 4 ms bursts and 16 ms interbusrts

Russian current 20%

Aussie current with 1000 Hz, modulated in bursts of 50 Hz, 500 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts

Aussie current 10%

Aussie current with 1000 Hz, modulated in bursts of 50 Hz, 500 µs and 20% duty cycle - 4 ms bursts and 16 ms interbusrts

Aussie current 20%

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female and male, aged between 18-40 years,
  • Be classified as physically active according to the International Physical Activity Questionnaire (IPAQ),
  • The practice of just recreational physical activity,
  • Achieve a minimum torque of 20% of the MVIC during the NMES
  • Be at least three months without strength training

You may not qualify if:

  • Present musculoskeletal dysfunction that may interfere with the tests, present intolerance to NMES in the triceps surae muscle,
  • Use analgesics, antidepressants, tranquilizers, or other centrally acting agents
  • Present cardiovascular or peripheral vascular problems, chronic diseases, neurological or muscle disorders that may impair the complete execution of the study design by the volunteer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

João Luiz Q. Durigan

Brasília, Brasil, 72220900, Brazil

Location

Related Publications (10)

  • Baldi JC, Jackson RD, Moraille R, Mysiw WJ. Muscle atrophy is prevented in patients with acute spinal cord injury using functional electrical stimulation. Spinal Cord. 1998 Jul;36(7):463-9. doi: 10.1038/sj.sc.3100679.

  • Vaz MA, Baroni BM, Geremia JM, Lanferdini FJ, Mayer A, Arampatzis A, Herzog W. Neuromuscular electrical stimulation (NMES) reduces structural and functional losses of quadriceps muscle and improves health status in patients with knee osteoarthritis. J Orthop Res. 2013 Apr;31(4):511-6. doi: 10.1002/jor.22264. Epub 2012 Nov 8.

  • Delitto A, Strube MJ, Shulman AD, Minor SD. A study of discomfort with electrical stimulation. Phys Ther. 1992 Jun;72(6):410-21; discussion on 421-4. doi: 10.1093/ptj/72.6.410.

  • 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.

  • McLoda TA, Carmack JA. Optimal burst duration during a facilitated quadriceps femoris contraction. J Athl Train. 2000 Apr;35(2):145-50.

  • Liebano RE, Waszczuk S Jr, Correa JB. The effect of burst-duty-cycle parameters of medium-frequency alternating current on maximum electrically induced torque of the quadriceps femoris, discomfort, and tolerated current amplitude in professional soccer players. J Orthop Sports Phys Ther. 2013 Dec;43(12):920-6. doi: 10.2519/jospt.2013.4656. Epub 2013 Oct 30.

  • Vanderthommen M, Duteil S, Wary C, Raynaud JS, Leroy-Willig A, Crielaard JM, Carlier PG. A comparison of voluntary and electrically induced contractions by interleaved 1H- and 31P-NMRS in humans. J Appl Physiol (1985). 2003 Mar;94(3):1012-24. doi: 10.1152/japplphysiol.00887.2001. Epub 2002 Nov 27.

  • Paz IA, Rigo GT, Sgarioni A, Baroni BM, Frasson VB, Vaz MA. Alternating Current Is More Fatigable Than Pulsed Current in People Who Are Healthy: A Double-Blind, Randomized Crossover Trial. Phys Ther. 2021 Jun 1;101(6):pzab056. doi: 10.1093/ptj/pzab056.

  • Arpin DJ, Forrest G, Harkema SJ, Rejc E. Submaximal Marker for Investigating Peak Muscle Torque Using Neuromuscular Electrical Stimulation after Paralysis. J Neurotrauma. 2019 Mar 19;36(6):930-936. doi: 10.1089/neu.2018.5848. Epub 2018 Nov 16.

  • Botter A, Oprandi G, Lanfranco F, Allasia S, Maffiuletti NA, Minetto MA. Atlas of the muscle motor points for the lower limb: implications for electrical stimulation procedures and electrode positioning. Eur J Appl Physiol. 2011 Oct;111(10):2461-71. doi: 10.1007/s00421-011-2093-y. Epub 2011 Jul 28.

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • João Durigan, PhD

    University of Brasilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 29, 2021

Study Start

November 2, 2021

Primary Completion

May 22, 2022

Study Completion

May 22, 2022

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations