HealthyNCT00512018
Neuromuscular Electrical Stimulation and Isokinetic Training
A study testing NMES and Isokinetic exercise in people with Healthy, run by Universidade Federal de Sao Carlos.
Trial summary
The purpose of this study was to assess the effects of Neuromuscular Electrical Stimulation (NMES) associated to an isokinetic training program in both young healthy men and women. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NMES and Isokinetic exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jul 2007
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The inclusion criteria were to be young (age range between 18 and 25 years), body mass index considered normal (between 20 and 25 kg/m²), practice of physical activity other than resistance training during the training period, absence of any neuromuscular disorders in lower limbs, no knee pain history.
Who cannot join
- The exclusion criteria were pregnancy, epilepsy, cancer, and suspicion on heart disease, recent surgery, respiratory disorders, non-compensated diabetes, and history of trauma, fracture or surgery in lower limbs, reports of pain at knee joint.
About this study
Official title: Neuromuscular Electrical Stimulation and Isokinetic Training: Effects on Strength and Neuromuscular Properties
The purpose of this study was to assess the effects of Neuromuscular Electrical Stimulation (NMES) associated to an isokinetic training program in both young healthy men and women. Twenty subjects (10 men, 10 women; 21±1.5 years) submitted both quadriceps femoris muscles to a strengthening program (3 sets of 10 isokinetic concentric repetitions at 30°/s) two days per week for 4 weeks. One limb was submitted only to the strength training (EX) while the other underwent the same training program but with NMES added to each contraction (Ex+NMES). The current used for NMES was Russian Current (frequency of 2500 Hz, 50 bursts/s and pulse duration of 200 µs). The evaluation protocol included isometric and isokinetic concentric extensor torques at 30°/s. Men increased their torque in both tested modalities in both limbs, with no difference between them. The angle of peak torque increased for the EX limb, showing an altered tension-length relationship, which did not occur for the Ex+NMES limb or for women. Women increased their torque for EX limb in both modalities, which only occured for isometric mode in the Ex+NMES limb. However, they showed a decrease in their acceleration time in Ex+NMES limbs, showing they could produce a muscular contraction more readily than they did before training. The results of this study found that the association between NMES and isokinetic concentric voluntary strength training does not improve strength gains of voluntary training itself for young healthy subjects of both genders. However, it could improve neuromuscular readiness to produce torque in women.
Read the detailed description
Subjects Twenty active and healthy undergraduate students (men: 21 ± 1.9 years; 1.77 ± 0.1 m; 73 ± 8.4 kg; 23.3 ± 1.4 kg/m²; women: 20.9 ± 0.7 years; 1.64 ± 0.1 m; 56.3 ± 5.5 kg; 21 ± 1.0 kg/m²) were selected for this study. All of them underwent physical examination before the study and had already participated in strength training programs before this study. All 10 men selected concluded the study. Although 15 women were selected and began the training program, 5 were excluded: 3 reported episodes of pain in the knee joint during training sessions, and 2 of them could not conclude the training program for personal reasons. Therefore, the final data refers to 10 women.
All procedures for evaluation and training were explained before and a consent term was signed. The project was approved by the Ethics Committee for Medical Research of Federal University of São Carlos and is in agreement with the Declaration of Helsinki.
Evaluation protocol Before all evaluations, subjects were familiarized with testing and training procedures. All the evaluation and training procedures were applied for both right and left limbs of subjects before and after training program. To avoid possible dominance effects, volunteers were randomly separated to determine in which limb (right or left) training would be associated with NMES. The investigator who made the data analysis was blind to this randomization.
After 5 min period of warm-up in a stationary bicycle at a speed of 20 km/h and load of 20 W, the subjects stretched the quadriceps femoris and the hamstring muscles of both limbs. Each muscle group was stretched 3 times of 30 s alternately. Afterwards, the subject was positioned in an isokinetic dynamometer (Biodex® Multi-joint System 3, Biodex, Shirley, NY), with the angulation of 100º on hips. Trunk, pelvis, and thigh of subjects were stabilized by strips, following equipment description36. Rotation axis of dynamometer was aligned with axis of the knee, at the level of lateral epicondyle of the femur, while the attachment was fixed at the distal part of leg of subjects, about 5 cm above medial malleolus. The gravity effect correction was calculated with the limb at 60° of flexion. The isokinetic device was calibrated before each evaluation and training session as requested by the manufacturer.
After that, volunteers had their knees positioned at 60° and were familiarized to the action they would do. After that, they were asked to perform 3 maximum voluntary isometric knee extension contractions for 5 s, with 1 min of rest interval between the contractions. Three min after the last contraction, subjects were familiarized with the isokinetic contraction and then performed 5 maximum isokinetic concentric knee extension contractions at 30º/s speed, from 90° to 15°, 0° being full extension, totaling up 75° of Range of Motion (ROM). Verbal encouragement37 as well as visual feedback from the equipment38 were given in an attempt to achieve a maximal voluntary effort level during all contractions each subject was asked to perform. The same procedures were repeated with the contralateral limb.
- Conditions
- Healthy
- Being tested
- NMES, Isokinetic exercise
- Keywords
- Electric Stimulation, Quadriceps Muscle, Muscle Strength, Neuromuscular Properties, Tension-Length Relationship, Healthy young adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESDevice
Also called Current generator Physiotonus Slim (Bioset, Brazil)
In the contralateral limb, the same protocol was repeated; however, each contraction was associated with overlapped NMES (Ex+NMES limbs).For the NMES, a symmetric double-phase sine-wave was used. Bearing wave frequency was of 2500 Hz, modulated in 50 bursts/s, with pulse duration of 200 µs, interburst interval of 10 ms. This configuration is known as "Russian current".
Isokinetic exerciseOther
Also called Isokinetic Dynamometer: Biodex Multi Joint System 3
Subjects realized training sessions twice a week with a 2-day minimum interval between the sessions, for 4 weeks. Each session included 5 min period of warm-up in a stationary bicycle, followed by 3 series of quadriceps stretching, as previously described. After being positioned at the isokinetic dynamometer, just as in the evaluation sessions, subjects firstly performed 3 sets of 10 maximum isokinetic concentric repetitions at the speed of 30º/s with one limb (EX limb), respecting the rest interval of 3 minutes between the sets.
| Study group | Role | What they receive |
|---|---|---|
| Isokinetic Exercise only | Active comparator | Individuals were asked to perform a 8-session training, twice a week, in which they trained the knee extensors muscles in an isokinetic dynamometer, 3 sets of 10 repetitions. Receives: Other: Isokinetic exercise |
| Isokinetic exercise + NMES | Experimental | In the contralateral limb, the same protocol was repeated; however, each contraction was associated with overlapped NMES (Ex+NMES). Receives: Device: NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between NMES and isokinetic concentric voluntary strength training did not improve strength gains of voluntary training itself for young healthy subjects of both genders.
Measured: Six months after stopping other type of strength training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startJan 2005
- Primary completionDec 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Arias Avila, Universidade Federal de Sao Carlos
- Investigators
- Mariana A Avila, PT, Principal investigator, Universidade Federal de Sao CarlosTania F Salvini, PhD, Study director, Universidade Federal de Sao CarlosJamilson S Brasileiro, PhD, Study chair, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512018
- Sponsor's protocol ID
- 067/03
- Status last verified
- Apr 2013
- First submitted
- 3 Aug 2007
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation and Isokinetic Training: Effects on Strength and Neuromuscular Properties
- ClinicalTrials.gov ID
- NCT00512018
- Acronym / sponsor ID
- 067/03
- Conditions
- Healthy
- Keywords
- Electric Stimulation, Quadriceps Muscle, Muscle Strength, Neuromuscular Properties, Tension-Length Relationship, Healthy young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 7 Aug 2007 (estimated)
- 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.
The purpose of this study was to assess the effects of Neuromuscular Electrical Stimulation (NMES) associated to an isokinetic training program in both young healthy men and women. Twenty subjects (10 men, 10 women; 21±1.5 years) submitted both quadriceps femoris muscles to a strengthening program (3 sets of 10 isokinetic concentric repetitions at 30°/s) two days per week for 4 weeks. One limb was submitted only to the strength training (EX) while the other underwent the same training program but with NMES added to each contraction (Ex+NMES). The current used for NMES was Russian Current (frequency of 2500 Hz, 50 bursts/s and pulse duration of 200 µs). The evaluation protocol included isometric and isokinetic concentric extensor torques at 30°/s. Men increased their torque in both tested modalities in both limbs, with no difference between them. The angle of peak torque increased for the EX limb, showing an altered tension-length relationship, which did not occur for the Ex+NMES limb or for women. Women increased their torque for EX limb in both modalities, which only occured for isometric mode in the Ex+NMES limb. However, they showed a decrease in their acceleration time in Ex+NMES limbs, showing they could produce a muscular contraction more readily than they did before training. The results of this study found that the association between NMES and isokinetic concentric voluntary strength training does not improve strength gains of voluntary training itself for young healthy subjects of both genders. However, it could improve neuromuscular readiness to produce torque in women.
Detailed description
Subjects Twenty active and healthy undergraduate students (men: 21 ± 1.9 years; 1.77 ± 0.1 m; 73 ± 8.4 kg; 23.3 ± 1.4 kg/m²; women: 20.9 ± 0.7 years; 1.64 ± 0.1 m; 56.3 ± 5.5 kg; 21 ± 1.0 kg/m²) were selected for this study. All of them underwent physical examination before the study and had already participated in strength training programs before this study. All 10 men selected concluded the study. Although 15 women were selected and began the training program, 5 were excluded: 3 reported episodes of pain in the knee joint during training sessions, and 2 of them could not conclude the training program for personal reasons. Therefore, the final data refers to 10 women.
All procedures for evaluation and training were explained before and a consent term was signed. The project was approved by the Ethics Committee for Medical Research of Federal University of São Carlos and is in agreement with the Declaration of Helsinki.
Evaluation protocol Before all evaluations, subjects were familiarized with testing and training procedures. All the evaluation and training procedures were applied for both right and left limbs of subjects before and after training program. To avoid possible dominance effects, volunteers were randomly separated to determine in which limb (right or left) training would be associated with NMES. The investigator who made the data analysis was blind to this randomization.
After 5 min period of warm-up in a stationary bicycle at a speed of 20 km/h and load of 20 W, the subjects stretched the quadriceps femoris and the hamstring muscles of both limbs. Each muscle group was stretched 3 times of 30 s alternately. Afterwards, the subject was positioned in an isokinetic dynamometer (Biodex® Multi-joint System 3, Biodex, Shirley, NY), with the angulation of 100º on hips. Trunk, pelvis, and thigh of subjects were stabilized by strips, following equipment description36. Rotation axis of dynamometer was aligned with axis of the knee, at the level of lateral epicondyle of the femur, while the attachment was fixed at the distal part of leg of subjects, about 5 cm above medial malleolus. The gravity effect correction was calculated with the limb at 60° of flexion. The isokinetic device was calibrated before each evaluation and training session as requested by the manufacturer.
After that, volunteers had their knees positioned at 60° and were familiarized to the action they would do. After that, they were asked to perform 3 maximum voluntary isometric knee extension contractions for 5 s, with 1 min of rest interval between the contractions. Three min after the last contraction, subjects were familiarized with the isokinetic contraction and then performed 5 maximum isokinetic concentric knee extension contractions at 30º/s speed, from 90° to 15°, 0° being full extension, totaling up 75° of Range of Motion (ROM). Verbal encouragement37 as well as visual feedback from the equipment38 were given in an attempt to achieve a maximal voluntary effort level during all contractions each subject was asked to perform. The same procedures were repeated with the contralateral limb.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isokinetic Exercise only | Active comparator | Other: Isokinetic exerciseIndividuals were asked to perform a 8-session training, twice a week, in which they trained the knee extensors muscles in an isokinetic dynamometer, 3 sets of 10 repetitions. |
| Isokinetic exercise + NMES | Experimental | Device: NMESIn the contralateral limb, the same protocol was repeated; however, each contraction was associated with overlapped NMES (Ex+NMES). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The inclusion criteria were to be young (age range between 18 and 25 years), body mass index considered normal (between 20 and 25 kg/m²), practice of physical activity other than resistance training during the training period, absence of any neuromuscular disorders in lower limbs, no knee pain history.
Key exclusion criteria (1 listed)
- The exclusion criteria were pregnancy, epilepsy, cancer, and suspicion on heart disease, recent surgery, respiratory disorders, non-compensated diabetes, and history of trauma, fracture or surgery in lower limbs, reports of pain at knee joint.
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 |
|---|---|---|
| NMESAlso: Current generator Physiotonus Slim (Bioset, Brazil)In the contralateral limb, the same protocol was repeated; however, each contraction was associated with overlapped NMES (Ex+NMES limbs).For the NMES, a symmetric double-phase sine-wave was used. Bearing wave frequency was of 2500 Hz, modulated in 50 bursts/s, with pulse duration of 200 µs, interburst interval of 10 ms. This configuration is known as "Russian current". | Device | Isokinetic exercise + NMES |
| Isokinetic exerciseAlso: Isokinetic Dynamometer: Biodex Multi Joint System 3Subjects realized training sessions twice a week with a 2-day minimum interval between the sessions, for 4 weeks. Each session included 5 min period of warm-up in a stationary bicycle, followed by 3 series of quadriceps stretching, as previously described. After being positioned at the isokinetic dynamometer, just as in the evaluation sessions, subjects firstly performed 3 sets of 10 maximum isokinetic concentric repetitions at the speed of 30º/s with one limb (EX limb), respecting the rest interval of 3 minutes between the sets. | Other | Isokinetic Exercise only |
Primary outcome
The association between NMES and isokinetic concentric voluntary strength training did not improve strength gains of voluntary training itself for young healthy subjects of both genders.
Time frame: Six months after stopping other type of strength training
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 18 Apr 2013.
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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.
Mariana A Avila, PT principal investigator
Universidade Federal de Sao Carlos
Tania F Salvini, PhD study director
Universidade Federal de Sao Carlos
Jamilson S Brasileiro, PhD study chair
Universidade Federal do Rio Grande do Norte
Questions about this trial
What is this clinical trial studying?
A study testing NMES and Isokinetic exercise in people with Healthy, run by Universidade Federal de Sao Carlos.
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 1 inclusion and 1 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 18 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The association between NMES and isokinetic concentric voluntary strength training did not improve strength gains of voluntary training itself for young healthy subjects of both genders. (time frame: Six months after stopping other type of strength training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2013; AzTrials last refreshed its copy on 30 Oct 2026.