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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04624438
Other study ID # 02-672-2/09-04-2015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 9, 2018
Est. completion date June 15, 2018

Study information

Verified date November 2020
Source University of Belgrade
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this investigation is to examine the effects of 6-week unilateral isometric training interventions over quadriceps femoris on maximal strength and RFD-SF parameters and cortical excitability. Isometric strength training involved either electromyostimulation, voluntary activation, or the combination of both. The second aim is to investigate the potential cross-over effect on a non-trained leg.


Description:

A longitudinal pre-post design with random assignment of the participants to one of three experimental groups or the control group was used. Quadriceps femoris (QF) function and cortical excitability were assessed on four occasions: prior to the intervention (pre-test), after 3 weeks of training (served for the adjustment of exercise intensity), after 6 weeks of training (post-test), and three weeks after the competition of training intervention (detraining) (Figure 1). Isometric strength training involves activation of QF applying EMS, VOLUNTARY, or the combination of both EMS and VOLUNTARY (COMBINED). The pre-test also served to familiarize participants with the training protocols and to determine the intensity of EMS needed to achieve 60%MVC. Quadriceps femoris (QF) function was assessed by MVC and RFD-SF. Cortical excitability was assessed with transcranial magnetic stimulation applied over the M1 region. Prior to the pretest, body mass and percent of body fat were assessed using a bioelectric impedance method (In Body 720; USA) and body height with a standard stadiometer. After the pretest, the participants were randomly assigned to either one of the experimental groups (EMS, VOLUNTARY, or COMBINED) and the control group (CONTROL). Experimental groups performed unilateral isometric strength training three times per week for 6 weeks. All participants were advised to refrain from all resistance training targeting the legs between pre-test and post-test.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date June 15, 2018
Est. primary completion date June 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 30 Years
Eligibility Inclusion Criteria: - young healthy, physically active participants of both genders Exclusion Criteria: - no history of injuries, muscle-skeletal or neurological disease, or medications intake

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Isometric training with electromyostimulation
Each training session (18 in total) consisted of forty 4-s contractions separated by 20 s inter-contraction intervals. The exercise intensity was close-to-identical among the sessions (60 %MVC). The force intensity was determined individually during pretest where EMS was delivered at maximal tolerable dose. Electrical stimulation was 6.25-second long and was followed by a rest period of 20-second (duty cycle 15%). Stimulation characteristics were selected among the "Compex" commercially available strength programs. The stimulation intensity was monitored on-line and determined by the subject at the start of each EMS session according to his/her pain threshold to produce a force corresponding to at least 60% of the pretest MVC score.
Isometric training with voluntary activation
Each training session (18 in total) consisted of forty 4-s contractions separated by 20 s inter-contraction intervals. The exercise intensity was close-to-identical among the sessions (60 %MVC). Participants were required to reach the proscribed force level only through voluntary activation of QF. To attain the same contraction/rest ratio as in EMS, automated audible signals were delivered in accordance with the contraction-rest pattern produced by the muscle stimulation device. To ensure participants produced 60% of individual MVC during each contraction the force level was measured with a force transducer and real-time feedback was provided on a computer screen.
Isometric training with combination of electromyostimulation and voluntary activation
Each training session (18 in total) consisted of forty 4-s contractions separated by 20 s inter-contraction intervals. The exercise intensity was close-to-identical among the sessions (60 %MVC). The proscribed force level was reached by the simultaneous action of EMS and VOLUNTARY. Each contraction was 6.25-second long and was followed by a rest period of 20-second (duty cycle 15%). Electrical stimulation corresponded to 30% of MVC, while the remaining 30% was achieved through voluntary muscle activation. To ensure participants produced a force corresponding to 60% of MVC during each contraction the force level was measured with a force transducer and real-time feedback was provided on a computer screen.

Locations

Country Name City State
Serbia Faculty of Sport and Physical Education, University of Belgrade Belgrade

Sponsors (4)

Lead Sponsor Collaborator
University of Belgrade University of Belgrade, Faculty of Sport and Physical Education, University of Belgrade, Institute for Medical Research, University of Primorska, Faculty of Health Sciences

Country where clinical trial is conducted

Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary MVC Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort Baseline
Primary MVC Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort After 3 weeks
Primary MVC Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort After 6 weeks
Primary MVC Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort After 9 weeks
Primary The slope of the rate-of-force development scaling factor (RFD-SF) The slope of the relationship (RFD-SF) between muscle force and rate of force development during rapid isometric contractions of varying intensities Baseline
Primary The slope of the rate-of-force development scaling factor (RFD-SF) The slope of the relationship (RFD-SF) between muscle force and rate of force development during rapid isometric contractions of varying intensities After 3 weeks
Primary The slope of the rate-of-force development scaling factor (RFD-SF) The slope of the relationship (RFD-SF) between muscle force and rate of force development during rapid isometric contractions of varying intensities After 6 weeks
Primary The slope of the rate-of-force development scaling factor (RFD-SF) The slope of the relationship (RFD-SF) between muscle force and rate of force development during rapid isometric contractions of varying intensities After 9 weeks
Primary Motor Evoked Potentials (MEP) MEPs were elicited in quadriceps femoris by transcranial magnetic stimulation (TMS) over M1 area. Motor cortex excitability was estimated by measuring the MEP amplitude (Input-Output, IO) peak to peak, caused by 20 randomized individual TMS stimulates with 100% (IO1), 120% (IO2) and 130% (IO3) of active motor threshold (AMT) intensity. Baseline
Primary Motor Evoked Potentials (MEP) MEPs were elicited in quadriceps femoris by transcranial magnetic stimulation (TMS) over M1 area. Motor cortex excitability was estimated by measuring the MEP amplitude (Input-Output, IO) peak to peak, caused by 20 randomized individual TMS stimulates with 100% (IO1), 120% (IO2) and 130% (IO3) of active motor threshold (AMT) intensity. After 3 weeks
Primary Motor Evoked Potentials (MEP) MEPs were elicited in quadriceps femoris by transcranial magnetic stimulation (TMS) over M1 area. Motor cortex excitability was estimated by measuring the MEP amplitude (Input-Output, IO) peak to peak, caused by 20 randomized individual TMS stimulates with 100% (IO1), 120% (IO2) and 130% (IO3) of active motor threshold (AMT) intensity. After 6 weeks
Primary Motor Evoked Potentials (MEP) MEPs were elicited in quadriceps femoris by transcranial magnetic stimulation (TMS) over M1 area. Motor cortex excitability was estimated by measuring the MEP amplitude (Input-Output, IO) peak to peak, caused by 20 randomized individual TMS stimulates with 100% (IO1), 120% (IO2) and 130% (IO3) of active motor threshold (AMT) intensity. After 9 weeks
Secondary The linearity of the rate-of-force development scaling factor (RFD-SF) relationship The linearity, described by coefficient of determination (r-squared) of the relationship (RFD-SF) between muscle force and rate of force Baseline
Secondary The linearity of the rate-of-force development scaling factor (RFD-SF) relationship The linearity, described by coefficient of determination (r-squared) of the relationship (RFD-SF) between muscle force and rate of force After 3 weeks
Secondary The linearity of the rate-of-force development scaling factor (RFD-SF) relationship The linearity, described by coefficient of determination (r-squared) of the relationship (RFD-SF) between muscle force and rate of force After 6 weeks
Secondary The linearity of the rate-of-force development scaling factor (RFD-SF) relationship The linearity, described by coefficient of determination (r-squared) of the relationship (RFD-SF) between muscle force and rate of force After 9 weeks
Secondary M-wave The tracing of the earliest electromyography (EMG) response to the stimulation of femoral nerve Baseline
Secondary M-wave The tracing of the earliest electromyography (EMG) response to the stimulation of femoral nerve After 3 weeks
Secondary M-wave The tracing of the earliest electromyography (EMG) response to the stimulation of femoral nerve After 6 weeks
Secondary M-wave The tracing of the earliest electromyography (EMG) response to the stimulation of femoral nerve After 9 weeks