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Effects of Neuromuscular Electrical Stimulation Parameters on Torque, Fatigue, and Oxygen Extraction (NMES)

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Russian current 10%
Russian current 20%
Aussie current 10%
Aussie current 20%
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fatigue focused on measuring Healthy Young, Electric Stimulation Therapy, Evoked torque, Sensory discomfort, Peripheral oxygen extraction

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • João Luiz Q. Durigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Russian current 10%

Russian current 20%

Aussie current 10%

Aussie current 20%

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Submaximal voluntary isometric contraction of the triceps surae
Expressed in muscle strength, assessed using an isokinetic dynamometer
Maximum voluntary isometric contraction of the triceps surae
Expressed in muscle strength, assessed using an isokinetic dynamometer
Maximum evoked torque
Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer
Torque evoked during the fatigue protocol
Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer
Peripheral oxygen extraction
Expressed by peripheral oxygen consumption assessed by near-infrared spectroscopy from the beginning to the end of the sessions
Muscle fatigue assessment before the muscle fatigue protocol
Expressed by mechanical properties of plantar flexors and central activation relationship using the contraction interpolation technique
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
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
Electromyographic signals
Expressed by the raw values of RMS and Median Frequency within a range of 500 ms throughout the entire session

Secondary Outcome Measures

Sensory discomfort during maximum evoked torques
Measured through the Visual Analog Scale (1 - 10 cm) where 0 represents no discomfort and 10 represents greater discomfort
Sensory discomfort during fatigue protocol
Measured through the Visual Analog Scale (1 - 10 cm) where 0 represents no discomfort and 10 represents greater discomfort

Full Information

First Posted
September 9, 2021
Last Updated
May 23, 2023
Sponsor
University of Brasilia
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1. Study Identification

Unique Protocol Identification Number
NCT05061056
Brief Title
Effects of Neuromuscular Electrical Stimulation Parameters on Torque, Fatigue, and Oxygen Extraction
Acronym
NMES
Official Title
Neuromuscular Electrical Stimulation: Comparison of Carrier Frequencies, Bursts Durations and Duty Cycles in the Generation of Evoked Torque, Sensory Discomfort, Muscle Fatigue and Peripheral Oxygen Extraction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
May 22, 2022 (Actual)
Study Completion Date
May 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Brasilia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a crossover, experimental, randomized, double-blind trial composed of apparently healthy participants. The objective 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. The effects of the types of neuromuscular electrical stimulation (NMES) protocols on the aforementioned outcomes will be evaluated in the same participant by randomizing the sequences of interventions for each visit in the laboratory. The study is considered double-blind, as individuals will not know the sequence of the protocols applied. The evaluator will also not know which protocol will be used at the time of the intervention. It will consist of a total of 6 sessions with seven days between them. In the first session, anthropometry, the maximum intensity level for each electrical stimulation protocol as well as the protocol sequence for each individual will be evaluated. From the second to the fifth session, the following will be considered: voluntary and evoked maximum joint torque of the triceps surae muscle, muscle fatigue through the evaluation of the H-reflex, M-wave, fatigue index, torque-time-integral and recruitment curve, peripheral oxygen extraction, electromyographic signals through RMS (root mean square) and median frequency, and level of sensory discomfort with the Visual Analog Scale (VAS). The last session will consist of the same electrical stimulation protocol from the second session of assessment. From the second to the fifth session will be composed by the following evaluation sequence: warm-up with six submaximal contractions with 6 seconds of duration and 10 seconds of rest between them; then the assessment of muscle fatigue; then three maximal isometric contractions, then three maximal evoked contractions; fatigue protocol at 20% of the maximum isometric contraction (this fatigue protocol will use the NMES sequence randomized in the first session, except on the fifth day that the NMES protocol used will be the same as the second day); after the fatigue protocol, three maximum evoked contractions will be performed again; then three maximal isometric contractions and at the end, the muscle fatigue evaluation will be performed again. The NMES protocols will be 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 of bursts and interbusrts of 16 ms), CA10% (Aussie current with 1000 Hz, modulated in bursts of 50 Hz, 500 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts), CA20% (Aussie current with 1000 Hz, modulated in bursts of 50 Hz, 500 µs and 20% duty cycle - 4 ms bursts and 16 interbusrts) ms) all protocols will be performed on the triceps surae muscle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Healthy Young, Electric Stimulation Therapy, Evoked torque, Sensory discomfort, Peripheral oxygen extraction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Russian current 10%
Arm Type
Experimental
Arm Description
Subjects will receive a interventions (Russian Current at 10% duty cycle). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated.
Arm Title
Russian current 20%
Arm Type
Experimental
Arm Description
Subjects will receive a interventions (Russian Current at 20% duty cycle). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated.
Arm Title
Aussie current 10%
Arm Type
Experimental
Arm Description
Subjects will receive a interventions (Aussie Current at 10% duty cycle). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated.
Arm Title
Aussie current 20%
Arm Type
Experimental
Arm Description
Subjects will receive a interventions (Aussie Current at 20% duty cycle). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated.
Intervention Type
Other
Intervention Name(s)
Russian current 10%
Intervention Description
Russian current with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts
Intervention Type
Other
Intervention Name(s)
Russian current 20%
Intervention Description
Russian current with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 20% duty cycle - 4 ms bursts and 16 ms interbusrts
Intervention Type
Other
Intervention Name(s)
Aussie current 10%
Intervention Description
Aussie current with 1000 Hz, modulated in bursts of 50 Hz, 500 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts
Intervention Type
Other
Intervention Name(s)
Aussie current 20%
Intervention Description
Aussie current with 1000 Hz, modulated in bursts of 50 Hz, 500 µs and 20% duty cycle - 4 ms bursts and 16 ms interbusrts
Primary Outcome Measure Information:
Title
Submaximal voluntary isometric contraction of the triceps surae
Description
Expressed in muscle strength, assessed using an isokinetic dynamometer
Time Frame
2 minutes
Title
Maximum voluntary isometric contraction of the triceps surae
Description
Expressed in muscle strength, assessed using an isokinetic dynamometer
Time Frame
5 minutes
Title
Maximum evoked torque
Description
Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer
Time Frame
5 minutes
Title
Torque evoked during the fatigue protocol
Description
Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer
Time Frame
20 minutes
Title
Peripheral oxygen extraction
Description
Expressed by peripheral oxygen consumption assessed by near-infrared spectroscopy from the beginning to the end of the sessions
Time Frame
40 minutes
Title
Muscle fatigue assessment before the muscle fatigue protocol
Description
Expressed by mechanical properties of plantar flexors and central activation relationship using the contraction interpolation technique
Time Frame
10 minutes
Title
Assessment of muscle fatigue during the muscle fatigue protocol
Description
Expressed by the muscle fatigue index through the decline in torque evoked from the beginning to the end of the protocol
Time Frame
20 minutes
Title
Muscle fatigue assessment during the muscle fatigue protocol
Description
Expressed by the decline in torque-time-integral from the beginning to the end of the protocol
Time Frame
20 minutes
Title
Electromyographic signals
Description
Expressed by the raw values of RMS and Median Frequency within a range of 500 ms throughout the entire session
Time Frame
40 minutes
Secondary Outcome Measure Information:
Title
Sensory discomfort during maximum evoked torques
Description
Measured through the Visual Analog Scale (1 - 10 cm) where 0 represents no discomfort and 10 represents greater discomfort
Time Frame
10 seconds
Title
Sensory discomfort during fatigue protocol
Description
Measured through the Visual Analog Scale (1 - 10 cm) where 0 represents no discomfort and 10 represents greater discomfort
Time Frame
10 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João Durigan, PhD
Organizational Affiliation
University of Brasilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
João Luiz Q. Durigan
City
Brasília
State/Province
Brasil
ZIP/Postal Code
72220900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9670381
Citation
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Results Reference
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Citation
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PubMed Identifier
1589461
Citation
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Citation
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Effects of Neuromuscular Electrical Stimulation Parameters on Torque, Fatigue, and Oxygen Extraction

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