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Electrical Stimulation With Different Currents: the Effects on Force, Tolerance and Fatigue in Healthy Subjects

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Neo-Russian
Aussie
RBS
Sponsored by
Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring electrical stimulation, Muscle Strength, Fatigue, assessments, pain

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Oscar Ronzio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Neo-Russian Electrical Stimulation

Aussie Electrical Stimulation

RBS Electrical Stimulation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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)
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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 8, 2017
Last Updated
February 11, 2021
Sponsor
Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló
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1. Study Identification

Unique Protocol Identification Number
NCT03340337
Brief Title
Electrical Stimulation With Different Currents: the Effects on Force, Tolerance and Fatigue in Healthy Subjects
Official Title
Effects on Isometric Force Induction, Tolerance and Fatigue of Burst-modulated Kilohertz Frequency (Neo-Russian and Aussie) and Low Frequency (Rectangular Biphasic Symmetrical) Neuromuscular Electrical Stimulation in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
electrical stimulation, Muscle Strength, Fatigue, assessments, pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neo-Russian Electrical Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Aussie Electrical Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
RBS Electrical Stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Neo-Russian
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Aussie
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
RBS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximal Voluntary Isometric Contraction (MVIC)
Description
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
Title
Maximal Electrical Induced Contraction (MEIC)
Description
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.
Title
Visual Analogue Scale (VAS)
Description
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.
Secondary Outcome Measure Information:
Title
Fatigue
Description
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.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Born as males.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar A Ronzio, D.H.Sc
Organizational Affiliation
Inst. Univer. Fund. H.A. Barceló - U. Maimónides - U. Nac. A. Jauretche
Official's Role
Study Director
Facility Information:
Facility Name
Oscar Ronzio
City
Ciudad Autónoma de Buenos Aire
State/Province
Caba
ZIP/Postal Code
1428
Country
Argentina

12. IPD Sharing Statement

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Electrical Stimulation With Different Currents: the Effects on Force, Tolerance and Fatigue in Healthy Subjects

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