Healthy
Conditions
Keywords
electrical stimulation, Muscle Strength, Fatigue, assessments, pain
Brief summary
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.
Interventions
DEVICENeo-Russian
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.
DEVICEAussie
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.
DEVICERBS
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.
Sponsors
Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers * Male * Right leg dominant * Exercising regularly
Exclusion criteria
* History of injuries in the right leg * Skin lesions * Having a pacemaker * Having a cardiovascular disease. * Having a neurological disorder. * Exercise 72 h before the procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Voluntary Isometric Contraction (MVIC) | MVIC was measured at the beggining of the research, on Day 1. Assessed in an average of 7 min | 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) |
| Maximal Electrical Induced Contraction (MEIC) | 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. | 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 |
| Visual Analogue Scale (VAS) | 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. | 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. * Minimum value: 0 * Maximum value: 10 * A higher score implicates a worse outcome. VAS was evaluated 3 times, 1 per type of electrical stimulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 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. | 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. |
Countries
Argentina
Participant flow
Recruitment details
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
Pre-assignment details
People that did exercise 72 h before the assignment and procedure were not included.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 24.6 years STANDARD_DEVIATION 3.06 |
| BMI | 24.71 kg/m^2 STANDARD_DEVIATION 1.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Argentina | 30 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
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
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Study Participants. | Maximal Electrical Induced Contraction (MEIC) | 30.30 percentage of MVIC |
| Aussie Electrical Stimulation | Maximal Electrical Induced Contraction (MEIC) | 13.44 percentage of MVIC |
| RBS Electrical Stimulation | Maximal Electrical Induced Contraction (MEIC) | 10.05 percentage of MVIC |
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)
Time frame: MVIC was measured at the beggining of the research, on Day 1. Assessed in an average of 7 min
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Study Participants. | Maximal Voluntary Isometric Contraction (MVIC) | 419.68 N |
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. * Minimum value: 0 * Maximum value: 10 * A higher score implicates a worse outcome. VAS was evaluated 3 times, 1 per type of electrical stimulation.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants. | Visual Analogue Scale (VAS) | 5.54 score on a scale | Standard Deviation 2.26 |
| Aussie Electrical Stimulation | Visual Analogue Scale (VAS) | 6.20 score on a scale | Standard Deviation 2.57 |
| RBS Electrical Stimulation | Visual Analogue Scale (VAS) | 5.15 score on a scale | Standard Deviation 2.59 |
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Study Participants. | Fatigue | 6.5 repetitions |
| Aussie Electrical Stimulation | Fatigue | 3.00 repetitions |
| RBS Electrical Stimulation | Fatigue | 0.00 repetitions |