HealthyNCT05894044
Effects of Kilohertz-frequency and Low-frequency Current on Triceps Surae
A study testing Russian current 10%, Aussie current 10% and Pulsed current 500 µs phase in people with Healthy, run by University of Brasilia at 1 site in Brazil.
Trial summary
Neuromuscular electrical Stimulation (NMES) can minimize muscle atrophy and complications related to muscle disuse and help improve neuromuscular performance. Medium and low-frequency currents have been assessed regarding the generation of evoked torque, sensory discomfort, muscle fatigue, and peripheral oxygen… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Russian current 10%, Aussie current 10% and Pulsed current 500 µs phase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 23 May 2023to 22 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Faculty of Ceilandia UnB
Brasília, Federal District, 72220-275
JOAO LUIZ Q DURIGAN, PhD, 55613107-8418, joaodurigan@gmail.com
JOAO LUIZ Q DURIGAN, +556198140862455613107-8418, joaodurigan@gmail.com
About this study
Official title: Effects of Different Modalities of Medium and Low Frequency Electrical Stimulation in the Generation of Evoked Torque, Sensory Discomfort, Muscle Fatigue and Inheritance Peripheral Oxygen Supply in the Triceps Surae Muscle.
Neuromuscular electrical Stimulation (NMES) can minimize muscle atrophy and complications related to muscle disuse and help improve neuromuscular performance. Medium and low-frequency currents have been assessed regarding the generation of evoked torque, sensory discomfort, muscle fatigue, and peripheral oxygen extraction. In addition, metabolic stress is also linked to muscle strength gain, an important aspect to be evaluated in addition to NMES physical parameters. 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 5 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 EENM protocols will be as follows: CR10% (Russian Current at 2500 Hz, modulated in 50 Hz bursts, 200 µs and 10% duty cycle - 2 ms of 18 ms bursts and interbusrts), CA10% (Aussie Current with 1000 Hz, modulated in 50 Hz bursts, 500 µs and 10% duty cycle - 2 ms of 18 ms bursts and interbusrts), CP500 (pulsed current with 50 Hz, 500 µs phase) and CP200 (Pulsed current with 50 Hz, 200 µs phase). all protocols will be performed on the triceps surae muscle.
Read the 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 5 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). 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 two maximal isometric contractions, then two 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; after the fatigue protocol, two maximum evoked contractions will be performed again; then two maximal isometric contractions and at the end, the muscle fatigue evaluation will be performed again. The NMES protocols will be CR10% (Russian Current at 2500 Hz, modulated in 50 Hz bursts, 200 µs and 10% duty cycle - 2 ms of 18 ms bursts and interbusrts), CA10% (Aussie Current with 1000 Hz, modulated in 50 Hz bursts, 500 µs and 10% duty cycle - 2 ms of 18 ms bursts and interbusrts), CP500 (pulsed current with 50 Hz, 500 µs phase) and CP200 (Pulsed current with 50 Hz, 200 µs phase). All protocols will be performed on the triceps surae muscle.
- Conditions
- Healthy
- Being tested
- Russian current 10%, Aussie current 10%, Pulsed current 500 µs phase, Pulsed current 200 µs phase
- Keywords
- Electrical stimulation, Burst, M-wave, H-reflex, Pulsed current, Russian current, Aussie Current
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Russian current 10%Other
Also called 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 with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts
Aussie current 10%Other
Aussie current with 1000 Hz, modulated in bursts of 50 Hz, 500 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts
Pulsed current 500 µs phaseOther
Pulsed current, modulated in 50 Hz, 500 µs
Pulsed current 200 µs phaseOther
Pulsed current, modulated in 50 Hz, 200 µs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Russian current 10% |
| 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. Receives: Other: Aussie current 10% |
| Pulsed current 500 µs phase | Experimental | Subjects will receive a interventions (Pulsed current with 50 Hz, 500 µs phase). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated. Receives: Other: Pulsed current 500 µs phase |
| Pulsed current 200 µs phase | Experimental | Subjects will receive a interventions (Pulsed current with 50 Hz, 200 µs phase). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated. Receives: Other: Pulsed current 200 µs phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Submaximal voluntary isometric contraction of the triceps surae
Expressed in muscle strength, assessed using an isokinetic dynamometer
Measured: 2 minutes
Maximum voluntary isometric contraction of the triceps surae
Expressed in muscle strength, assessed using an isokinetic dynamometer
Measured: 5 minutes
Maximum evoked torque
Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer
Measured: 5 minutes
Torque evoked during the fatigue protocol
Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer
Measured: 15 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
Measured: 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
Measured: 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
Measured: 20 minutes
Secondary outcomes (4)
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
Measured: 10 seconds
Sensory discomfort during fatigue protocol
Measured through the Visual Analog Scale (1 - 10 cm) where 0 represents no discomfort and 10 represents greater discomfort
Measured: 10 seconds
Electromyographic signals
Expressed by the raw values of RMS and Median Frequency within a range of 500 ms throughout the entire session
Measured: 40 minutes
Peripheral oxygen extraction
Expressed by peripheral oxygen consumption assessed by near-infrared spectroscopy from the beginning to the end of the sessions
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start23 May 2023
- Primary completion22 May 2024 (estimated)
- Study completion22 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a crossover, experimental, randomized, double-blind trial composed of apparently healthy participants.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- João LQ Durigan, PhD, Principal investigator, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894044
- Sponsor's protocol ID
- 67915523.1.0000.8093
- Status last verified
- May 2023
- First submitted
- 30 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The authors consider sharing the data depending on the situation.
Publications
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.
PubMed 9670381Ward AR, Lucas-Toumbourou S, McCarthy B. A comparison of the analgesic efficacy of medium-frequency alternating current and TENS. Physiotherapy. 2009 Dec;95(4):280-8. doi: 10.1016/j.physio.2009.06.005. Epub 2009 Sep 2.
PubMed 19892092Aldayel A, Jubeau M, McGuigan M, Nosaka K. Comparison between alternating and pulsed current electrical muscle stimulation for muscle and systemic acute responses. J Appl Physiol (1985). 2010 Sep;109(3):735-44. doi: 10.1152/japplphysiol.00189.2010. Epub 2010 Jul 1.
PubMed 20595542Arpin 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.
PubMed 30226407Martin A, Grospretre S, Vilmen C, Guye M, Mattei JP, LE Fur Y, Bendahan D, Gondin J. The Etiology of Muscle Fatigue Differs between Two Electrical Stimulation Protocols. Med Sci Sports Exerc. 2016 Aug;48(8):1474-84. doi: 10.1249/MSS.0000000000000930.
PubMed 27031743Neyroud D, Dodd D, Gondin J, Maffiuletti NA, Kayser B, Place N. Wide-pulse-high-frequency neuromuscular stimulation of triceps surae induces greater muscle fatigue compared with conventional stimulation. J Appl Physiol (1985). 2014 May 15;116(10):1281-9. doi: 10.1152/japplphysiol.01015.2013. Epub 2014 Mar 27.
PubMed 24674861Pinto Damo NL, Modesto KA, Neto IVS, Bottaro M, Babault N, Durigan JLQ. Effects of different electrical stimulation currents and phase durations on submaximal and maximum torque, efficiency, and discomfort: a randomized crossover trial. Braz J Phys Ther. 2021 Sep-Oct;25(5):593-600. doi: 10.1016/j.bjpt.2021.03.001. Epub 2021 Mar 26.
PubMed 33840592da Silva VZ, Durigan JL, Arena R, de Noronha M, Gurney B, Cipriano G Jr. Current evidence demonstrates similar effects of kilohertz-frequency and low-frequency current on quadriceps evoked torque and discomfort in healthy individuals: a systematic review with meta-analysis. Physiother Theory Pract. 2015;31(8):533-9. doi: 10.3109/09593985.2015.1064191. Epub 2015 Oct 14.
PubMed 26467544Bellew JW, Cayot T, Brown K, Blair C, Dishion T, Ortman B, Reel A. Changes in microvascular oxygenation and total hemoglobin concentration of the vastus lateralis during neuromuscular electrical stimulation (NMES). Physiother Theory Pract. 2021 Aug;37(8):926-934. doi: 10.1080/09593985.2019.1652945. Epub 2019 Aug 12.
PubMed 31402741
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Modalities of Medium and Low Frequency Electrical Stimulation in the Generation of Evoked Torque, Sensory Discomfort, Muscle Fatigue and Inheritance Peripheral Oxygen Supply in the Triceps Surae Muscle.
- ClinicalTrials.gov ID
- NCT05894044
- Acronym / sponsor ID
- 67915523.1.0000.8093
- Conditions
- Healthy
- Keywords
- Electrical stimulation, Burst, M-wave, H-reflex, Pulsed current, Russian current, Aussie Current
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 22 May 2024 (estimated)
- Study completion
- 22 May 2024 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuromuscular electrical Stimulation (NMES) can minimize muscle atrophy and complications related to muscle disuse and help improve neuromuscular performance. Medium and low-frequency currents have been assessed regarding the generation of evoked torque, sensory discomfort, muscle fatigue, and peripheral oxygen extraction. In addition, metabolic stress is also linked to muscle strength gain, an important aspect to be evaluated in addition to NMES physical parameters. 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 5 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 EENM protocols will be as follows: CR10% (Russian Current at 2500 Hz, modulated in 50 Hz bursts, 200 µs and 10% duty cycle - 2 ms of 18 ms bursts and interbusrts), CA10% (Aussie Current with 1000 Hz, modulated in 50 Hz bursts, 500 µs and 10% duty cycle - 2 ms of 18 ms bursts and interbusrts), CP500 (pulsed current with 50 Hz, 500 µs phase) and CP200 (Pulsed current with 50 Hz, 200 µs phase). 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 5 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). 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 two maximal isometric contractions, then two 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; after the fatigue protocol, two maximum evoked contractions will be performed again; then two maximal isometric contractions and at the end, the muscle fatigue evaluation will be performed again. The NMES protocols will be CR10% (Russian Current at 2500 Hz, modulated in 50 Hz bursts, 200 µs and 10% duty cycle - 2 ms of 18 ms bursts and interbusrts), CA10% (Aussie Current with 1000 Hz, modulated in 50 Hz bursts, 500 µs and 10% duty cycle - 2 ms of 18 ms bursts and interbusrts), CP500 (pulsed current with 50 Hz, 500 µs phase) and CP200 (Pulsed current with 50 Hz, 200 µs phase). All protocols will be performed on the triceps surae muscle.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This is a crossover, experimental, randomized, double-blind trial composed of apparently healthy participants.
| Arm | Type | Receives |
|---|---|---|
| Russian current 10% | Experimental | Other: Russian current 10%Subjects will receive a interventions (Russian Current at 10% duty cycle). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated. |
| Aussie current 10% | Experimental | Other: Aussie current 10%Subjects will receive a interventions (Aussie Current at 10% duty cycle). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated. |
| Pulsed current 500 µs phase | Experimental | Other: Pulsed current 500 µs phaseSubjects will receive a interventions (Pulsed current with 50 Hz, 500 µs phase). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated. |
| Pulsed current 200 µs phase | Experimental | Other: Pulsed current 200 µs phaseSubjects will receive a interventions (Pulsed current with 50 Hz, 200 µs phase). Evoked torque, muscle fatigue, sensory discomfort, and peripheral oxygen extraction will be evaluated. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Russian current 10%Also: Russian current with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrtsRussian current with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts | Other | Russian current 10% |
| Aussie current 10%Aussie current with 1000 Hz, modulated in bursts of 50 Hz, 500 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts | Other | Aussie current 10% |
| Pulsed current 500 µs phasePulsed current, modulated in 50 Hz, 500 µs | Other | Pulsed current 500 µs phase |
| Pulsed current 200 µs phasePulsed current, modulated in 50 Hz, 200 µs | Other | Pulsed current 200 µs phase |
Primary outcome
Submaximal voluntary isometric contraction of the triceps surae
Time frame: 2 minutes
Expressed in muscle strength, assessed using an isokinetic dynamometer
Maximum voluntary isometric contraction of the triceps surae
Time frame: 5 minutes
Expressed in muscle strength, assessed using an isokinetic dynamometer
Maximum evoked torque
Time frame: 5 minutes
Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer
Torque evoked during the fatigue protocol
Time frame: 15 minutes
Expressed by the description of muscle strength generated by electrical stimulation assessed by the isokinetic dynamometer
Muscle fatigue assessment before the muscle fatigue protocol
Time frame: 10 minutes
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
Time frame: 20 minutes
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
Time frame: 20 minutes
Expressed by the decline in torque-time-integral from the beginning to the end of the protocol
4 secondary outcomes
Sensory discomfort during maximum evoked torques
Time frame: 10 seconds
Sensory discomfort during fatigue protocol
Time frame: 10 seconds
Electromyographic signals
Time frame: 40 minutes
Peripheral oxygen extraction
Time frame: 40 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Background: PubMed 9670381Baldi 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.
- Background: PubMed 19892092Ward AR, Lucas-Toumbourou S, McCarthy B. A comparison of the analgesic efficacy of medium-frequency alternating current and TENS. Physiotherapy. 2009 Dec;95(4):280-8. doi: 10.1016/j.physio.2009.06.005. Epub 2009 Sep 2.
- Background: PubMed 20595542Aldayel A, Jubeau M, McGuigan M, Nosaka K. Comparison between alternating and pulsed current electrical muscle stimulation for muscle and systemic acute responses. J Appl Physiol (1985). 2010 Sep;109(3):735-44. doi: 10.1152/japplphysiol.00189.2010. Epub 2010 Jul 1.
- Background: PubMed 30226407Arpin 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.
- Background: PubMed 27031743Martin A, Grospretre S, Vilmen C, Guye M, Mattei JP, LE Fur Y, Bendahan D, Gondin J. The Etiology of Muscle Fatigue Differs between Two Electrical Stimulation Protocols. Med Sci Sports Exerc. 2016 Aug;48(8):1474-84. doi: 10.1249/MSS.0000000000000930.
- Background: PubMed 24674861Neyroud D, Dodd D, Gondin J, Maffiuletti NA, Kayser B, Place N. Wide-pulse-high-frequency neuromuscular stimulation of triceps surae induces greater muscle fatigue compared with conventional stimulation. J Appl Physiol (1985). 2014 May 15;116(10):1281-9. doi: 10.1152/japplphysiol.01015.2013. Epub 2014 Mar 27.
- Background: PubMed 33840592Pinto Damo NL, Modesto KA, Neto IVS, Bottaro M, Babault N, Durigan JLQ. Effects of different electrical stimulation currents and phase durations on submaximal and maximum torque, efficiency, and discomfort: a randomized crossover trial. Braz J Phys Ther. 2021 Sep-Oct;25(5):593-600. doi: 10.1016/j.bjpt.2021.03.001. Epub 2021 Mar 26.
- Background: PubMed 26467544da Silva VZ, Durigan JL, Arena R, de Noronha M, Gurney B, Cipriano G Jr. Current evidence demonstrates similar effects of kilohertz-frequency and low-frequency current on quadriceps evoked torque and discomfort in healthy individuals: a systematic review with meta-analysis. Physiother Theory Pract. 2015;31(8):533-9. doi: 10.3109/09593985.2015.1064191. Epub 2015 Oct 14.
- Background: PubMed 31402741Bellew JW, Cayot T, Brown K, Blair C, Dishion T, Ortman B, Reel A. Changes in microvascular oxygenation and total hemoglobin concentration of the vastus lateralis during neuromuscular electrical stimulation (NMES). Physiother Theory Pract. 2021 Aug;37(8):926-934. doi: 10.1080/09593985.2019.1652945. Epub 2019 Aug 12.
- Individual participant dataSharing planned: No. The authors consider sharing the data depending on the situation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João LQ Durigan, PhD principal investigator
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Russian current 10%, Aussie current 10% and Pulsed current 500 µs phase in people with Healthy, run by University of Brasilia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact João LQ Durigan, PhD (61 3107-8450 ext. +55, joaodurigan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Submaximal voluntary isometric contraction of the triceps surae (time frame: 2 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05894044, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.