Healthy YoungNCT03796117
Pulsed Current Versus Russian Current Effects in Healthy Young Subjects.
A study testing Pulsed current and Russian Current in people with Healthy Young and Electric Stimulation Therapy, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
Low frequency pulsed current (PC) and medium frequency alternating current (Russian current - RC, 2.5 kHz) have been largely studied due to their clinical use. However, it is not clear which current is the most efficient due to the existente literature conflicts.Therefore, the purpose of this study is to compare the… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Young, Electric Stimulation Therapy
- What is being tested?
- Pulsed current and Russian Current
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Jan 2019to 30 Aug 2019
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young male
- Age between 18 and 35 years
- Physically active,
- Normal knee function and range of motion
- No pain complaints
- No presence of lower limb pathology at the dominant limb.
Who cannot join
- Health problems (neurological, musculoskeletal impairment),
- Contraindication to maximal exercise,
- Having been treated with NMES in the last 3 months in the lower limb
- Not meeting the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690-200
About this study
Official title: Neuromuscular Parameters, Current Intensity and Discomfort Level Between Pulsed Current and Russian Current in Healthy Young Subjects.
Low frequency pulsed current (PC) and medium frequency alternating current (Russian current - RC, 2.5 kHz) have been largely studied due to their clinical use. However, it is not clear which current is the most efficient due to the existente literature conflicts.Therefore, the purpose of this study is to compare the neuromuscular efficiency, evoked torque, current intensity, fatigability and level of discomfort between the PC and the RC in healthy young. The current types will be tested in the same participant by the intervention sequences randomization. On the first, second, third and fourth days, the maximum voluntary isometric contraction (MVIC), the current intensity level, discomfort level, evoked torque, and clinical and neuromuscular efficiency of each current will be evaluated. Anthropometric measurements will also be assessed on the first day. In addition, the current intensity required to produce a torque level of 20% of the MVIC, the current intensity required to generate a torque of 40 Nm and the maximum intensity tolerated by the participant will be evaluated. Three contractions will be recorded in each condition, and the level of discomfort will be assessed during the evoked contractions. Evoked torque will be evaluated at the maximum tolerated intensity level using the isokinetic dynamometer. Clinical and neuromuscular efficiency will be evaluated (1) at the current intensity necessary to evoke 20% MVIC, (2) at the current intensity necessary to generate 40 Nm, and (3) at the maximum tolerated current intensity. On the fifth and sixth days, muscle fatigue induced by the diferente current types will be evaluated. Fatigue will be evaluated with sufficient current intensity to generate 20% of the MVIC. MVIC will be performed before and after the fatigue protocol, and the fatigue will be determined by the relative variation of the MVIC before and after the fatigue protocol. Fatigue will also be evaluated through the evoked torque variation between the first and the last minute of the fatigue protocol, as well as by the total work generated in each protocol. Neuromuscular efficiency will be evaluated before and immediately after the protocol through (1) the ratio between input NMES current intensity and output evoked torque, (2) total work (area under the evoked force by time curves) generated during the fatigue protocol, and (3) by the changes in muscle architecture from rest to evoked contraction at the maximal current intensity.
Read the detailed description
This study is characterized by a quantitative approach, with a randomized crossover clinical study design, blinded to evaluators and participants. The objective is to compare the neuromuscular and clinical efficiency, evoked torque, current intensity, fatigue and discomfort level between the low frequency biphasic pulsed current (PC) and the median frequency sinusoidal alternating Russian current (RC) in healthy young participants. The effect of the two neuromuscular electrical stimulation (NMES) current types on the cited variables will be evaluated in the same participant, by means of the randomization of the interventions sequences for each participant. The evaluation protocols will be performed by 2 blinded raters for the current type and for the outcome variables. A blinded evaluator to the study will randomize the current type, which will be applied on the different evaluation days, through a lottery using opaque envelopes. A researcher blinded to the study groups will analyze the data. Participants will be blinded to the current type will be receiving. The evaluations will be performed in six days, and a minimum interval of 7 days will be observed between the evaluation days. On the first, second, third and fourth days, characterized as Stage 1, the currents' intensity levels, discomfort level, evoked torque, and neuromuscular and clinical efficiency of each randomized current will be evaluated. On the fifth and sixth days, characterized as Stage 2, the muscle fatigue level induced by the two electrical currents will be evaluated. The first evaluation day will be divided into two phases. Phase 1 corresponds to the initial evaluation, anthropometric data collection and physical activity level evaluation. In Phase 2, the quadriceps femoris motor point will be located with a pen-shaped electrode and a neuromuscular electrical stimulation unit, and the subcutaneous adipose layer thickness covering the motor point will be evaluated by means of ultrasonography. Subsequently, the ultrasound probe will be maintained on the vastus lateralis muscle (VL) to obtain muscle architecture data at rest, during the maximal voluntary isometric contractions (MVICs) and during the evoked contractions. Next, a warming up protocol will be performed and the participants will perform three MVICs at the knee joint angles of 60° and 90° of knee flexion (0° = full knee extension) on the isokinetic dynamometer. Subsequently, the investigators will evaluate (1) the current intensity required to produce a torque equivalent to 20% MVIC, (2) the current intensity required to produce a 40 Nm torque, the maximum current intensity (mA) tolerated by the subject (3) at an angle of 60° of knee flexion, and (4) at 90° of knee flexion. From these evaluations, the investigators will analyze the neuromuscular efficiency (ratio between current intensity and evoked torque). After each NMES test, participants will indicate, on the visual-analog scale, the discomfort level perceived with each NMES current type. Clinical efficiency will be evaluated by the ratio between the discomfort level and the evoked torque in the above-described situations. On the second, third and fourth evaluation day, participants will perform all the evaluations described in Phase 2 of the first evaluation day, but with different configurations of the type of current randomized being applied. On the fifth day, the fatigue protocol will be applied with appropriated parameters according to the randomized current type, and sufficient current intensity to generate 20% of the MVIC. The discomfort level during the fatigue protocol will be recorded immediately after the end of the fatigue test. Participants will conduct three pre- and post-fatigue protocol MVICs in order to assess the fatigue level. For the sixth evaluation day, the same evaluations reported for the fifth day will be carried out, but with the second randomized current.
- Conditions
- Healthy Young, Electric Stimulation Therapy
- Being tested
- Pulsed current, Russian Current
- Keywords
- Muscle Strength, Fatigue, Neuromuscular efficiency, Discomfort level, Electric Stimulation
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed currentDevice
For stage 1 of the study, which corresponds to analysis of the evoked torque, evaluation of the discomfort level, current intensity, analysis of neuromuscular efficiency and clinical efficiency, 2 configurations (PC1 and PC2) will be used.
PC1, will be set at a frequency of 100 Hz, phase duration of 1000 microseconds, ON-OFF time of 5s:10s.
PC2, will be set at a frequency of 100 Hz, phase duration of 200 microseconds ON-OFF time of 5s:10s.
For stage 2 of the study, which corresponds to the analysis of the fatigability level, only the PC1 configuration will be used.
Russian CurrentDevice
For stage 1 of the study, which corresponds to analysis of the evoked torque, discomfort level, current intensity, neuromuscular efficiency and clinical efficiency, 2 configurations (RC1 and RC2) will be used.
RC1, will be set to a frequency of 100 Hz, burst duty cycle of 20%, ON-OFF time of 5s:10s.
RC2, will be set at a frequency of 100 Hz, burst duty cycle of 50%, ON-OFF time of 5s:10s.
For stage 2 of the study, which corresponds to the analysis of the fatigability level, only the RC2 configuration will be used.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1: healthy young | Experimental | Participants receive two interventions (Pulsed Current - PC, or Russian Current - RC) in a specific order, according to randomization. Evoked torque, discomfort level, current intensity, neuromuscular efficiency, clinical efficiency and fatigability level will be evaluated. Receives: Device: Pulsed current; Device: Russian Current |
| Experimental Group 2: healthy young | Experimental | Participants receive two interventions (Pulsed Current - PC, or Russian Current - RC) in a specific order, according to randomization. Evoked torque, discomfort level, current intensity, neuromuscular efficiency, clinical efficiency and fatigability level will be evaluated. Receives: Device: Pulsed current; Device: Russian Current |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum voluntary isometric contraction of the knee extensors
is an expression of the muscular strength, and will be evaluated by dynamometry.
Measured: 14 minutes
Knee extensors evoked torque during the tests at submaximal current intensity levels
is an expression describing the muscular strength generated by electrical stimulation, and will be assessed by dynamometry.
Measured: During 90 seconds of electrical stimulation
Knee extensors evoked torque during the tests at maximal current intensity levels
is an expression describing the muscular strength generated by electrical stimulation, and will be assessed by dynamometry.
Measured: During 90 seconds of electrical stimulation
Knee extensors evoked torque during the fatigue protocol
is an expression describing the muscular strength generated by electrical stimulation, and will be assessed by dynamometry.
Measured: During 20 minutes of electrical stimulation
Muscular architecture during the knee extensors maximum voluntary isometric contraction tests
is an expression used to describe the muscle fibers arrangement within the muscle, and is evaluated by determining the muscle thickness, fascicle pennation angle and fascicle length, which will be assessed by ultrasonography.
Measured: 14 minutes
Muscular architecture during knee extensors evoked torque tests at submaximal current intensity levels
is an expression used to describe the muscle fibers arrangement within the muscle, and is evaluated by determining the muscle thickness, fascicle pennation angle and fascicle length, which will be assessed by ultrasonography.
Measured: During 90 seconds of electrical stimulation
Muscular architecture during knee extensors evoked torque tests at maximal current intensity levels
is an expression used to describe the muscle fibers arrangement within the muscle, and is evaluated by determining the muscle thickness, fascicle pennation angle and fascicle length, which will be assessed by ultrasonography.
Measured: During 90 seconds of electrical stimulation
Muscular architecture during the fatigue protocol
is an expression used to describe the muscle fibers arrangement within the muscle, and is evaluated by determining the muscle thickness, fascicle pennation angle and fascicle length, which will be assessed by ultrasonography.
Measured: During 20 minutes of electrical stimulation
Discomfort level generated by electrical stimulation during evoked torque tests at submaximal current intensity levels
Discomfort will be measured with a Visual Analogue Scale (0-100mm), where 0 and 100 mm corresponded to no discomfort and worst perceived discomfort, respectively.
Measured: During 90 seconds of electrical stimulation
Discomfort level generated by electrical stimulation during evoked torque tests at maximal current intensity levels
Discomfort will be measured with a Visual Analogue Scale (0-100mm), where 0 and 100 mm corresponded to no discomfort and worst perceived discomfort, respectively.
Measured: During 90 seconds of electrical stimulation
Discomfort level generated by electrical stimulation during the fatigue protocol
Discomfort will be measured with a Visual Analogue Scale (0-100mm), where 0 and 100 mm corresponded to no discomfort and worst perceived discomfort, respectively.
Measured: During 20 minutes of electrical stimulation
Current intensity required to evoke knee extensors submaximal torque
Current intensity is defined as the amount or amplitude of electrical current (in milliamperes - mA) required to achieve a specific force, and will be evaluated in the electrical stimulation device.
Measured: During 90 seconds of electrical stimulation
Current intensity required to evoke knee extensors maximal torque
Current intensity is defined as the amount or amplitude of electrical current (in milliamperes - mA) required to achieve a specific force, and will be evaluated in the electrical stimulation device.
Measured: During 90 seconds of electrical stimulation
Neuromuscular efficiency during knee extensors submaximal evoked torque tests
Neuromuscular efficiency of the electrical currents will be evaluated by calculating the current intensity (input parameter or input) by the evoked torque (output parameter) ratio.
Measured: During 90 seconds of electrical stimulation
Neuromuscular efficiency during knee extensors maximal evoked torque tests
Neuromuscular efficiency of the electrical currents will be evaluated by calculating the current intensity (input parameter or input) by the evoked torque (output parameter) ratio.
Measured: During 90 seconds of electrical stimulation
Neuromuscular efficiency during the fatigue protocol
Neuromuscular efficiency of the electrical currents will be evaluated by calculating the current intensity (input parameter or input) by the evoked torque (output parameter) ratio.
Measured: During 20 minutes of electrical stimulation
Clinical efficiency during knee extensors submaximal evoked torque tests
Clinical efficiency of the two electrical currents will be evaluated by calculating the ratio between the evoked torque (output parameter) and the level of discomfort generated.
Measured: During 90 seconds of electrical stimulation
Clinical efficiency during knee extensors maximal evoked torque tests
Clinical efficiency of the two electrical currents will be evaluated by calculating the ratio between the evoked torque (output parameter) and the level of discomfort generated.
Measured: During 90 seconds of electrical stimulation
Clinical efficiency during the fatigue protocol
Clinical efficiency of the two electrical currents will be evaluated by calculating the ratio between the evoked torque (output parameter) and the level of discomfort generated.
Measured: During 20 minutes of electrical stimulation
Muscle Fatigue Index
Characterized by the force decrease after the fatigue protocol, it will be evaluated by dynamometry.
Measured: During 20 minutes of electrical stimulation
Fatigue Index from Evoked Torque
Characterized by the decrease of the evoked torque during the fatigue protocol, the fatigue index from evoked torque will be evaluated by dynamometry, and obtained by the analysis of evoked torque curves.
Measured: During 20 minutes of electrical stimulation
Total work generated during the fatigue protocol
The torque-time integral of the evoked torque curves during the fatigue protocol will be evaluated. The sum of the torque curve integral of all evoked contractions during the fatigue protocol will be calculated to determine the total work evoked by each current during the fatigue protocol.
Measured: During 20 minutes of electrical stimulation
Secondary outcomes (2)
Thickness of the subcutaneous fat layer on the motor point
Corresponds to the amount of subcutaneous adipose tissue and will be evaluated by ultrasonography.
Measured: It will be evaluated during the first evaluation day.
Level of physical activity
The level of physical activity (PA) of each subject will be assessed by the International Physical Activity Questionnaire (IPAQ).The scores will be assessed by calculating the metabolic equivalents (MET) for each activity level. Walking score will be achieved by the multiplication of 3.3 METs with the total walking duration in minutes in a week. Moderate physical activity scores will be achieved by the multiplication of 4.0 METs with the total moderate physical activity duration in minutes in a week. Vigorous physical activity scores will be achieved by the multiplication of 8.0 METs with the total vigorous physical activity duration in minutes in a week. Total physical activity MET-minutes/week will be obtained through sum of walking, moderate and vigorous MET minutes/week scores. Categorical Score will be classified into three levels of physical activity: low, moderate and high.
Measured: 8 minutes. It will be evaluated during the first evaluation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start8 Jan 2019
- Primary completion30 Jun 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy YoungStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
- Investigators
- Marco A Vaz, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796117
- Sponsor's protocol ID
- 3.064.351
- Status last verified
- Jun 2021
- First submitted
- 24 Dec 2018
- Last updated
- 10 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paz IA, Rigo GT, Sgarioni A, Baroni BM, Frasson VB, Vaz MA. Alternating Current Is More Fatigable Than Pulsed Current in People Who Are Healthy: A Double-Blind, Randomized Crossover Trial. Phys Ther. 2021 Jun 1;101(6):pzab056. doi: 10.1093/ptj/pzab056.
PubMed 33561279
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Parameters, Current Intensity and Discomfort Level Between Pulsed Current and Russian Current in Healthy Young Subjects.
- ClinicalTrials.gov ID
- NCT03796117
- Acronym / sponsor ID
- 3.064.351
- Conditions
- Healthy Young, Electric Stimulation Therapy
- Keywords
- Muscle Strength, Fatigue, Neuromuscular efficiency, Discomfort level, Electric Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 8 Jan 2019 (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.
Low frequency pulsed current (PC) and medium frequency alternating current (Russian current - RC, 2.5 kHz) have been largely studied due to their clinical use. However, it is not clear which current is the most efficient due to the existente literature conflicts.Therefore, the purpose of this study is to compare the neuromuscular efficiency, evoked torque, current intensity, fatigability and level of discomfort between the PC and the RC in healthy young. The current types will be tested in the same participant by the intervention sequences randomization. On the first, second, third and fourth days, the maximum voluntary isometric contraction (MVIC), the current intensity level, discomfort level, evoked torque, and clinical and neuromuscular efficiency of each current will be evaluated. Anthropometric measurements will also be assessed on the first day. In addition, the current intensity required to produce a torque level of 20% of the MVIC, the current intensity required to generate a torque of 40 Nm and the maximum intensity tolerated by the participant will be evaluated. Three contractions will be recorded in each condition, and the level of discomfort will be assessed during the evoked contractions. Evoked torque will be evaluated at the maximum tolerated intensity level using the isokinetic dynamometer. Clinical and neuromuscular efficiency will be evaluated (1) at the current intensity necessary to evoke 20% MVIC, (2) at the current intensity necessary to generate 40 Nm, and (3) at the maximum tolerated current intensity. On the fifth and sixth days, muscle fatigue induced by the diferente current types will be evaluated. Fatigue will be evaluated with sufficient current intensity to generate 20% of the MVIC. MVIC will be performed before and after the fatigue protocol, and the fatigue will be determined by the relative variation of the MVIC before and after the fatigue protocol. Fatigue will also be evaluated through the evoked torque variation between the first and the last minute of the fatigue protocol, as well as by the total work generated in each protocol. Neuromuscular efficiency will be evaluated before and immediately after the protocol through (1) the ratio between input NMES current intensity and output evoked torque, (2) total work (area under the evoked force by time curves) generated during the fatigue protocol, and (3) by the changes in muscle architecture from rest to evoked contraction at the maximal current intensity.
Detailed description
This study is characterized by a quantitative approach, with a randomized crossover clinical study design, blinded to evaluators and participants. The objective is to compare the neuromuscular and clinical efficiency, evoked torque, current intensity, fatigue and discomfort level between the low frequency biphasic pulsed current (PC) and the median frequency sinusoidal alternating Russian current (RC) in healthy young participants. The effect of the two neuromuscular electrical stimulation (NMES) current types on the cited variables will be evaluated in the same participant, by means of the randomization of the interventions sequences for each participant. The evaluation protocols will be performed by 2 blinded raters for the current type and for the outcome variables. A blinded evaluator to the study will randomize the current type, which will be applied on the different evaluation days, through a lottery using opaque envelopes. A researcher blinded to the study groups will analyze the data. Participants will be blinded to the current type will be receiving. The evaluations will be performed in six days, and a minimum interval of 7 days will be observed between the evaluation days. On the first, second, third and fourth days, characterized as Stage 1, the currents' intensity levels, discomfort level, evoked torque, and neuromuscular and clinical efficiency of each randomized current will be evaluated. On the fifth and sixth days, characterized as Stage 2, the muscle fatigue level induced by the two electrical currents will be evaluated. The first evaluation day will be divided into two phases. Phase 1 corresponds to the initial evaluation, anthropometric data collection and physical activity level evaluation. In Phase 2, the quadriceps femoris motor point will be located with a pen-shaped electrode and a neuromuscular electrical stimulation unit, and the subcutaneous adipose layer thickness covering the motor point will be evaluated by means of ultrasonography. Subsequently, the ultrasound probe will be maintained on the vastus lateralis muscle (VL) to obtain muscle architecture data at rest, during the maximal voluntary isometric contractions (MVICs) and during the evoked contractions. Next, a warming up protocol will be performed and the participants will perform three MVICs at the knee joint angles of 60° and 90° of knee flexion (0° = full knee extension) on the isokinetic dynamometer. Subsequently, the investigators will evaluate (1) the current intensity required to produce a torque equivalent to 20% MVIC, (2) the current intensity required to produce a 40 Nm torque, the maximum current intensity (mA) tolerated by the subject (3) at an angle of 60° of knee flexion, and (4) at 90° of knee flexion. From these evaluations, the investigators will analyze the neuromuscular efficiency (ratio between current intensity and evoked torque). After each NMES test, participants will indicate, on the visual-analog scale, the discomfort level perceived with each NMES current type. Clinical efficiency will be evaluated by the ratio between the discomfort level and the evoked torque in the above-described situations. On the second, third and fourth evaluation day, participants will perform all the evaluations described in Phase 2 of the first evaluation day, but with different configurations of the type of current randomized being applied. On the fifth day, the fatigue protocol will be applied with appropriated parameters according to the randomized current type, and sufficient current intensity to generate 20% of the MVIC. The discomfort level during the fatigue protocol will be recorded immediately after the end of the fatigue test. Participants will conduct three pre- and post-fatigue protocol MVICs in order to assess the fatigue level. For the sixth evaluation day, the same evaluations reported for the fifth day will be carried out, but with the second randomized current.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1: healthy young | Experimental | Device: Pulsed current, Device: Russian CurrentParticipants receive two interventions (Pulsed Current - PC, or Russian Current - RC) in a specific order, according to randomization. Evoked torque, discomfort level, current intensity, neuromuscular efficiency, clinical efficiency and fatigability level will be evaluated. |
| Experimental Group 2: healthy young | Experimental | Device: Pulsed current, Device: Russian CurrentParticipants receive two interventions (Pulsed Current - PC, or Russian Current - RC) in a specific order, according to randomization. Evoked torque, discomfort level, current intensity, neuromuscular efficiency, clinical efficiency and fatigability level will be evaluated. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Young male
- Age between 18 and 35 years
- Physically active,
- Normal knee function and range of motion
- No pain complaints
Key exclusion criteria (4 listed)
- Health problems (neurological, musculoskeletal impairment),
- Contraindication to maximal exercise,
- Having been treated with NMES in the last 3 months in the lower limb
- Not meeting the inclusion criteria.
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 |
|---|---|---|
| Pulsed currentFor stage 1 of the study, which corresponds to analysis of the evoked torque, evaluation of the discomfort level, current intensity, analysis of neuromuscular efficiency and clinical efficiency, 2 configurations (PC1 and PC2) will be used. PC1, will be set at a frequency of 100 Hz, phase duration of 1000 microseconds, ON-OFF time of 5s:10s. PC2, will be set at a frequency of 100 Hz, phase duration of 200 microseconds ON-OFF time of 5s:10s. For stage 2 of the study, which corresponds to the analysis of the fatigability level, only the PC1 configuration will be used. | Device | Experimental Group 1: healthy young, Experimental Group 2: healthy young |
| Russian CurrentFor stage 1 of the study, which corresponds to analysis of the evoked torque, discomfort level, current intensity, neuromuscular efficiency and clinical efficiency, 2 configurations (RC1 and RC2) will be used. RC1, will be set to a frequency of 100 Hz, burst duty cycle of 20%, ON-OFF time of 5s:10s. RC2, will be set at a frequency of 100 Hz, burst duty cycle of 50%, ON-OFF time of 5s:10s. For stage 2 of the study, which corresponds to the analysis of the fatigability level, only the RC2 configuration will be used. | Device | Experimental Group 1: healthy young, Experimental Group 2: healthy young |
Primary outcome
Maximum voluntary isometric contraction of the knee extensors
Time frame: 14 minutes
is an expression of the muscular strength, and will be evaluated by dynamometry.
Knee extensors evoked torque during the tests at submaximal current intensity levels
Time frame: During 90 seconds of electrical stimulation
is an expression describing the muscular strength generated by electrical stimulation, and will be assessed by dynamometry.
Knee extensors evoked torque during the tests at maximal current intensity levels
Time frame: During 90 seconds of electrical stimulation
is an expression describing the muscular strength generated by electrical stimulation, and will be assessed by dynamometry.
Knee extensors evoked torque during the fatigue protocol
Time frame: During 20 minutes of electrical stimulation
is an expression describing the muscular strength generated by electrical stimulation, and will be assessed by dynamometry.
Muscular architecture during the knee extensors maximum voluntary isometric contraction tests
Time frame: 14 minutes
is an expression used to describe the muscle fibers arrangement within the muscle, and is evaluated by determining the muscle thickness, fascicle pennation angle and fascicle length, which will be assessed by ultrasonography.
Muscular architecture during knee extensors evoked torque tests at submaximal current intensity levels
Time frame: During 90 seconds of electrical stimulation
is an expression used to describe the muscle fibers arrangement within the muscle, and is evaluated by determining the muscle thickness, fascicle pennation angle and fascicle length, which will be assessed by ultrasonography.
Muscular architecture during knee extensors evoked torque tests at maximal current intensity levels
Time frame: During 90 seconds of electrical stimulation
is an expression used to describe the muscle fibers arrangement within the muscle, and is evaluated by determining the muscle thickness, fascicle pennation angle and fascicle length, which will be assessed by ultrasonography.
Muscular architecture during the fatigue protocol
Time frame: During 20 minutes of electrical stimulation
is an expression used to describe the muscle fibers arrangement within the muscle, and is evaluated by determining the muscle thickness, fascicle pennation angle and fascicle length, which will be assessed by ultrasonography.
Discomfort level generated by electrical stimulation during evoked torque tests at submaximal current intensity levels
Time frame: During 90 seconds of electrical stimulation
Discomfort will be measured with a Visual Analogue Scale (0-100mm), where 0 and 100 mm corresponded to no discomfort and worst perceived discomfort, respectively.
Discomfort level generated by electrical stimulation during evoked torque tests at maximal current intensity levels
Time frame: During 90 seconds of electrical stimulation
Discomfort will be measured with a Visual Analogue Scale (0-100mm), where 0 and 100 mm corresponded to no discomfort and worst perceived discomfort, respectively.
Discomfort level generated by electrical stimulation during the fatigue protocol
Time frame: During 20 minutes of electrical stimulation
Discomfort will be measured with a Visual Analogue Scale (0-100mm), where 0 and 100 mm corresponded to no discomfort and worst perceived discomfort, respectively.
Current intensity required to evoke knee extensors submaximal torque
Time frame: During 90 seconds of electrical stimulation
Current intensity is defined as the amount or amplitude of electrical current (in milliamperes - mA) required to achieve a specific force, and will be evaluated in the electrical stimulation device.
Current intensity required to evoke knee extensors maximal torque
Time frame: During 90 seconds of electrical stimulation
Current intensity is defined as the amount or amplitude of electrical current (in milliamperes - mA) required to achieve a specific force, and will be evaluated in the electrical stimulation device.
Neuromuscular efficiency during knee extensors submaximal evoked torque tests
Time frame: During 90 seconds of electrical stimulation
Neuromuscular efficiency of the electrical currents will be evaluated by calculating the current intensity (input parameter or input) by the evoked torque (output parameter) ratio.
Neuromuscular efficiency during knee extensors maximal evoked torque tests
Time frame: During 90 seconds of electrical stimulation
Neuromuscular efficiency of the electrical currents will be evaluated by calculating the current intensity (input parameter or input) by the evoked torque (output parameter) ratio.
Neuromuscular efficiency during the fatigue protocol
Time frame: During 20 minutes of electrical stimulation
Neuromuscular efficiency of the electrical currents will be evaluated by calculating the current intensity (input parameter or input) by the evoked torque (output parameter) ratio.
Clinical efficiency during knee extensors submaximal evoked torque tests
Time frame: During 90 seconds of electrical stimulation
Clinical efficiency of the two electrical currents will be evaluated by calculating the ratio between the evoked torque (output parameter) and the level of discomfort generated.
Clinical efficiency during knee extensors maximal evoked torque tests
Time frame: During 90 seconds of electrical stimulation
Clinical efficiency of the two electrical currents will be evaluated by calculating the ratio between the evoked torque (output parameter) and the level of discomfort generated.
Clinical efficiency during the fatigue protocol
Time frame: During 20 minutes of electrical stimulation
Clinical efficiency of the two electrical currents will be evaluated by calculating the ratio between the evoked torque (output parameter) and the level of discomfort generated.
Muscle Fatigue Index
Time frame: During 20 minutes of electrical stimulation
Characterized by the force decrease after the fatigue protocol, it will be evaluated by dynamometry.
Fatigue Index from Evoked Torque
Time frame: During 20 minutes of electrical stimulation
Characterized by the decrease of the evoked torque during the fatigue protocol, the fatigue index from evoked torque will be evaluated by dynamometry, and obtained by the analysis of evoked torque curves.
Total work generated during the fatigue protocol
Time frame: During 20 minutes of electrical stimulation
The torque-time integral of the evoked torque curves during the fatigue protocol will be evaluated. The sum of the torque curve integral of all evoked contractions during the fatigue protocol will be calculated to determine the total work evoked by each current during the fatigue protocol.
2 secondary outcomes
Thickness of the subcutaneous fat layer on the motor point
Time frame: It will be evaluated during the first evaluation day.
Level of physical activity
Time frame: 8 minutes. It will be evaluated during the first evaluation day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Derived from this study: PubMed 33561279Paz IA, Rigo GT, Sgarioni A, Baroni BM, Frasson VB, Vaz MA. Alternating Current Is More Fatigable Than Pulsed Current in People Who Are Healthy: A Double-Blind, Randomized Crossover Trial. Phys Ther. 2021 Jun 1;101(6):pzab056. doi: 10.1093/ptj/pzab056.
- Individual participant dataSharing planned: No
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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.
Marco A Vaz, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed current and Russian Current in people with Healthy Young and Electric Stimulation Therapy, run by Federal University of Rio Grande do Sul 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 10 Jun 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum voluntary isometric contraction of the knee extensors (time frame: 14 minutes). The study lists 22 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 NCT03796117, which also lists 1 linked publication.
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 10 Jun 2021.