Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05894044
Status:
RECRUITING
Last Update Posted:
2023-06-08
First Post:
2023-05-30
Brief Title:
Effects of Kilohertz-frequency and Low-frequency Current on Triceps Surae
Sponsor:
University of Brasilia
Organization:
University of Brasilia
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None