Neuromuscular Electrical Stimulation and Isokinetic Training
| Tracking Information | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 3, 2007 | ||||||||||||
| Last Updated Date | April 17, 2013 | ||||||||||||
| Start Date ICMJE | January 2005 | ||||||||||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||||||||||
| Change History | Complete list of historical versions of study NCT00512018 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Neuromuscular Electrical Stimulation and Isokinetic Training | ||||||||||||
| Official Title ICMJE | Neuromuscular Electrical Stimulation and Isokinetic Training: Effects on Strength and Neuromuscular Properties | ||||||||||||
| Brief 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. 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 Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) |
||||||||||||
| Condition ICMJE | Healthy | ||||||||||||
| Intervention ICMJE |
|
||||||||||||
| Study Arm (s) |
|
||||||||||||
| Publications * | Not Provided | ||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||
| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 20 | ||||||||||||
| Completion Date | July 2007 | ||||||||||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||
| Gender | Both | ||||||||||||
| Ages | 18 Years to 25 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Not Provided | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00512018 | ||||||||||||
| Other Study ID Numbers ICMJE | 067/03 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Mariana Arias Avila, Universidade Federal de Sao Carlos | ||||||||||||
| Study Sponsor ICMJE | Universidade Federal de Sao Carlos | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
|
||||||||||||
| Information Provided By | Universidade Federal de Sao Carlos | ||||||||||||
| Verification Date | April 2013 | ||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||