Ignite Creation Date:
2024-05-06 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05061056
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2021-09-09
Brief Title:
Effects of Neuromuscular Electrical Stimulation Parameters on Torque Fatigue and Oxygen Extraction
Sponsor:
University of Brasilia
Organization:
University of Brasilia
Study Overview
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
Status:
COMPLETED
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:
NMES
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
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