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Muscle strength is the amount of force generated by muscle contraction. It could be measured with an isometric dynamometer. This is a validated tool that could be used to measure Maximal Voluntary Isometric Contraction (MVIC) and Maximal Electrical Induced Contraction (MEIC). It is claimed that higher MEIC values will result in more force gained.
If a current is more tolerated it will be easier to achieve better MEIC values. Tolerance to an electrical stimulation could be measured with the Visual Analogue Scale (VAS). A ratio between Normalized MEIC / VAS is often used, implying that the current is better with a higher ratio.
Muscle fatigue is defined as a temporary loss or decrease in force-generating ability due to previous contractions. It is claimed that medium frequency neuromuscular electrical stimulation (NMES) generates more fatigue than low frequency currents.
Aussie is a medium-frequency alternating current, sinusoidal waveform, 1 KHz carrier frequency.
Neo-Russian is a medium-frequency current, rectangular biphasic symmetrical waveform, 2,5 KHz carrier frequency.
Rectangular Biphasic symmetrical (RBS) waveform is a type of Low Pulsed Current (LPC), claimed to be better than classical Russian Current.
Purpose:
As it has been claimed that LPC is better in MEIC and tolerance, the aim of this study is to compare it with two newer medium frequency currents in terms of MEIC, tolerance and fatigue.
Methods:
Thirty male subjects, right leg dominant, will receive randomly the 3 types of electrical stimulation. Before that, the MVIC will be measured for data normalization.
The MVIC and MEIC will be measured with an isometric dynamometer. In both measurements, subjects will be asked to perform three reps (5 sec work x 120 sec rest) and the best one will be used. Whenever the third one was the best, additional measurements will be taken until a decrease in torque will be obtained to determine the maximum.
To apply Aussie electrical stimulation, an Aussie Sport (Ibramed) will be used. To apply Neo-Russian, a Neurodyn III (Ibramed) will be used. To apply RBS, a Genesy (Globus) will be used.
The VAS will be used to assess tolerance to each treatment. One week later, the subjects will receive, randomly, a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest) of electrical stimulation with the three types of current. The data will be normalized with the MVIC and the reps equal or below 50 % of the first rep will be considered as a fatigue rep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neo-Russian Electrical Stimulation | Experimental | MVIC will be measured for data normalization. The subjects will receive Neo-Russian electrical stimulation. The Maximal Elicited Induced Contraction (MEIC) will be measured. One week later, after a washout period, the fatigue will be measured with this type of current. |
|
| Aussie Electrical Stimulation | Experimental | MVIC will be measured for data normalization. The subjects will receive Aussie electrical stimulation. The Maximal Elicited Induced Contraction (MEIC) will be measured. One week later, after a washout period, the fatigue will be measured with this type of current. |
|
| RBS Electrical Stimulation | Experimental | MVIC will be measured for data normalization. The subjects will receive RBS electrical stimulation. The Maximal Elicited Induced Contraction (MEIC) will be measured. One week later, after a washout period, the fatigue will be measured with this type of current. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neo-Russian | Device | Subjects will receive Neo-Russian electrical stimulation with three reps (5 sec work x 120 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured. They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS). One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Voluntary Isometric Contraction (MVIC) | Force generated by the patient during a maximal voluntary isometric contraction, measured by an isometric dynamometer with load cell and computer interface. The best of the 3 repetitions was considered. Whenever the third one was the best, additional measurements were taken until a decrease in torque was obtained in order to determine the maximum. Unit: Newtons (N) | MVIC was measured at the beggining of the research, on Day 1. Assessed in an average of 7 min |
| Maximal Electrical Induced Contraction (MEIC) | Force generated in the muscle while applying electrical stimulation, measured by an isometric dynamometer with load cell and computer interface. This data (in Newtons) was normalized with the MVIC. Unit: percentage of MVIC | MEIC was measured on Day 1. Order: MVIC - Rest: 120 sec. - MEIC current 1 - Rest: 120 sec. - MEIC current 2 - Rest: 120 sec. - MEIC current 3 - Rest: 120 sec. - Assessed in an average of 21 min. |
| Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS): Magnitude of pain, marked in a analogue scale by participants, to determine how unpleasant was each type of electrical stimulation (applied in randomized order). Expresed in centimeters.
| Asked after evaluation of MEIC wiht each type of current. VAS current 1 - VAS current 2 - VAS current 3 - Assessed in average of 15 seconds for each current. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Number of repetitions, while applying electrical stimulation, equal to or lower than 50% of the first of 21 reps, previously normalized with MVIC Units: units on scale. Range: from 0 to 21. A higher value represents a worse outcome. | Washout: 1 Week. Fatigue current 1 - Rest: 120 sec. - Fatigue current 2 - Rest: 120 sec. - Fatigue current 3 - Assessed in an average of 21 min. |
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Inclusion Criteria:
Exclusion Criteria:
Born as males.
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| Name | Affiliation | Role |
|---|---|---|
| Oscar A Ronzio, D.H.Sc | Inst. Univer. Fund. H.A. Barceló - U. Maimónides - U. Nac. A. Jauretche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oscar Ronzio | Ciudad Autónoma de Buenos Aire | Buenos Aires F.D. | 1428 | Argentina |
People that did exercise 72 h before the assignment and procedure were not included.
Sampling: Consecutive non-probability. Population: Students pursuing a degree in Kinesiology and Physiatry at Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló, at Universidad Maimónides and at Universidad Nacional Arturo Jauretche that met the criteria and accepted to participate.
Study Start: November 30, 2017 / Study Completion: December 30, 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants |
Dosing information: Contraction parameters: Ramp-up: 1 sec On time: 3 sec Ramp-down: 1 sec Total work time: 5 sec Rest time: 5 sec Reps: 21. Current parameters: Same as previous. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Maximal Voluntary Isometric Contraction (MVIC) will be measured for data normalization. Then, the subjects will receive 3 types of electrical stimulation (Neo-Russian, Aussie and RBS), in a randomized order. The Maximal Elicited Induced Contraction (MEIC) will be measured. An isometric dynamometer will be used for acquiring MVIC and MEIC. The protocol will be 3 reps x 5 sec work x 120 sec rest and the best rep will be used. Whenever the third one was the best, additional measurements will be taken until a decrease in torque will be obtained to determine the maximum. One week later, the subjects will receive a fatigue protocol with the three types of electrical stimulation applied in the randomized order that consists in 21 reps (5 sec work x 5 sec rest). The data will be normalized with the MVIC and the reps equal or below 50 % of the first rep will be considered as a fatigue rep. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximal Voluntary Isometric Contraction (MVIC) | Force generated by the patient during a maximal voluntary isometric contraction, measured by an isometric dynamometer with load cell and computer interface. The best of the 3 repetitions was considered. Whenever the third one was the best, additional measurements were taken until a decrease in torque was obtained in order to determine the maximum. Unit: Newtons (N) | All the participants received 3 types of electrical stimulation (Neo-Russian, Aussie and RBS), in a randomized order, to determine MEIC and Fatigue. As the MVIC was used to normalize "MEIC" and "Fatigue", all study participants were included into one arm. | Posted | Median | Inter-Quartile Range | N | MVIC was measured at the beggining of the research, on Day 1. Assessed in an average of 7 min |
|
2 weeks
Participant were asked if they experiment delayed onset muscle soreness (DOMS) or any other kind of pain.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neo-Russian Electrical Stimulation | MVIC was measured for data normalization. Subjects received Neo-Russian electrical stimulation with three reps (5 sec work x 120 sec rest), and the Maximal Electrical Induced Contraction (MEIC) was measured. They were asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS). One week later, subjects received a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) was measured for each contraction. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oscar Ronzio | Universidad Maimónides - Universidad Nacional Arturo Jauretche - Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló | +54-11-4905-1140 | ronzio.oscar@maimonides.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2019 | Feb 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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Thirty male subjects, right leg dominant, will receive 3 types of electrical stimulation in a randomized order. Aussie current will be delivered by Aussie Sport (Ibramed) device, Neo-Russian by Neurodyn III (Ibramed) device and RBS by a Genesy (Globus) device.
MVIC and MEIC will be measured with an isometric dynamometer (3 reps x 5 sec work x 120 sec rest). The best rep will be used. Whenever the third one was the best, additional measurements will be taken until a decrease in torque will be obtained to determine the maximum. MVIC will be used for data normalization.
The VAS will be used to assess tolerance to each treatment. A ratio between MEIC and VAS will be calculated.
One week later, subjects will receive, ramdomly, a fatigue protocol with the three types of electrical stimulation that consists in 21 reps (5 sec work x 5 sec rest). The data will be normalized with the MVIC and the reps equal or below 50 % of the first rep will be considered as a fatigue rep.
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|
| Aussie | Device | Subjects will receive Aussie electrical stimulation with three reps (5 sec work x 120 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured. They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS). One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction. |
|
| RBS | Device | Subjects will receive RBS electrical stimulation with three reps (5 sec work x 120 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured. They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS). One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Primary | Maximal Electrical Induced Contraction (MEIC) | Force generated in the muscle while applying electrical stimulation, measured by an isometric dynamometer with load cell and computer interface. This data (in Newtons) was normalized with the MVIC. Unit: percentage of MVIC | Posted | Median | Inter-Quartile Range | percentage of MVIC | MEIC was measured on Day 1. Order: MVIC - Rest: 120 sec. - MEIC current 1 - Rest: 120 sec. - MEIC current 2 - Rest: 120 sec. - MEIC current 3 - Rest: 120 sec. - Assessed in an average of 21 min. |
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| Primary | Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS): Magnitude of pain, marked in a analogue scale by participants, to determine how unpleasant was each type of electrical stimulation (applied in randomized order). Expresed in centimeters.
| Posted | Mean | Standard Deviation | score on a scale | Asked after evaluation of MEIC wiht each type of current. VAS current 1 - VAS current 2 - VAS current 3 - Assessed in average of 15 seconds for each current. |
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| Secondary | Fatigue | Number of repetitions, while applying electrical stimulation, equal to or lower than 50% of the first of 21 reps, previously normalized with MVIC Units: units on scale. Range: from 0 to 21. A higher value represents a worse outcome. | Posted | Median | Inter-Quartile Range | repetitions | Washout: 1 Week. Fatigue current 1 - Rest: 120 sec. - Fatigue current 2 - Rest: 120 sec. - Fatigue current 3 - Assessed in an average of 21 min. |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Aussie Electrical Stimulation | MVIC was measured for data normalization. Subjects received Aussie electrical stimulation with three reps (5 sec work x 120 sec rest), and the Maximal Electrical Induced Contraction (MEIC) was measured. They were asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS). One week later, subjects received a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) was measured for each contraction. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | RBS Electrical Stimulation | MVIC was measured for data normalization. Subjects received RBS electrical stimulation with three reps (5 sec work x 120 sec rest), and the Maximal Electrical Induced Contraction (MEIC) was measured. They were asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS). One week later, subjects received a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) was measured for each contraction. | 0 | 30 | 0 | 30 | 0 | 30 |
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