Clinical trial NCT05061056: Effects of Neuromuscular Electrical Stimulation Parameters on Torque, Fatigue, and Oxygen Extraction
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
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: Healthy Young
Electric Stimulation Therapy
Evoked torque
Sensory discomfort
Peripheral oxygen extraction
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Submaximal voluntary isometric contraction of the triceps surae
timeFrame: 2 minutes
measure: Maximum voluntary isometric contraction of the triceps surae
timeFrame: 5 minutes
measure: Maximum evoked torque
timeFrame: 5 minutes
measure: Torque evoked during the fatigue protocol
timeFrame: 20 minutes
measure: Peripheral oxygen extraction
timeFrame: 40 minutes
measure: Muscle fatigue assessment before the muscle fatigue protocol
timeFrame: 10 minutes
measure: Assessment of muscle fatigue during the muscle fatigue protocol
timeFrame: 20 minutes
measure: Muscle fatigue assessment during the muscle fatigue protocol
timeFrame: 20 minutes
measure: Electromyographic signals
timeFrame: 40 minutes
Secondary outcomes:
measure: Sensory discomfort during maximum evoked torques
timeFrame: 10 seconds
measure: Sensory discomfort during fatigue protocol
timeFrame: 10 seconds
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: João Luiz Q. Durigan
state: Brasil
Study officials:
affiliation: University of Brasilia
name: João Durigan, PhD
role: PRINCIPAL_INVESTIGATOR
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