- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00512018
Neuromuscular Electrical Stimulation and Isokinetic Training
Neuromuscular Electrical Stimulation and Isokinetic Training: Effects on Strength and Neuromuscular Properties
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Isokinetic Exercise only
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.
|
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.
Other Names:
|
Experimental: Isokinetic exercise + NMES
In the contralateral limb, the same protocol was repeated; however, each contraction was associated with overlapped NMES (Ex+NMES).
|
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".
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Six months after stopping other type of strength training
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mariana A Avila, PT, Universidade Federal de Sao Carlos
- Study Director: Tania F Salvini, PhD, Universidade Federal de Sao Carlos
- Study Chair: Jamilson S Brasileiro, PhD, Universidade Federal do Rio Grande do Norte
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 067/03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Isokinetic exercise
-
Prof. Dr. Cemil Tascıoglu Education and Research...CompletedMultiple Sclerosis
-
Hacettepe UniversityCompleted
-
Cukurova UniversityCompletedHemiplegia | Stroke RehabilitationTurkey
-
Taichung Veterans General HospitalRecruitingStroke | Arthroplasty, Replacement, Knee | Resistance Training | Arthroplasty, Replacement, HipTaiwan
-
Aristotle University Of ThessalonikiCompleted
-
University of SydneyCompleted
-
King Saud UniversityCompletedMuscle StrengthSaudi Arabia
-
University of BrasiliaCompleted
-
Sema DağcıRecruitingSarcopenia | Osteoarthritis of the KneeTurkey
-
Cleber FerraresiUniversidade Federal do Rio Grande do NorteCompleted