- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04624438
Central and Peripheral Changes in Quadriceps Femoris Function After Different Types of Isometric Strength Training
November 5, 2020 updated by: Dragan Mirkov, University of Belgrade
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Belgrade, Serbia, 11030
- Faculty of Sport and Physical Education, University of Belgrade
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Electromyostimulation - EMS
Experimental group comprised of healthy young adults that undergoes unilateral isometric training using electromyostimulation over quadriceps femoris
|
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.
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Experimental: Voluntary activation - VOLUNTARY
Experimental group comprised of healthy young adults that undergoes unilateral isometric training based on voluntary activation of quadriceps femoris
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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.
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Experimental: Combination of EMS and VOLUNTARY - COMBINED
Experimental group comprised of healthy young adults that undergoes unilateral isometric training that combines electromyostimulation and voluntary activation of quadriceps femoris.
|
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.
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No Intervention: Control group - CONTROL
Group of healthy young adults who received no intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MVC
Time Frame: Baseline
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Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort
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Baseline
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MVC
Time Frame: After 3 weeks
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Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort
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After 3 weeks
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MVC
Time Frame: After 6 weeks
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Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort
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After 6 weeks
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MVC
Time Frame: After 9 weeks
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Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort
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After 9 weeks
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The slope of the rate-of-force development scaling factor (RFD-SF)
Time Frame: Baseline
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The slope of the relationship (RFD-SF) between muscle force and rate of force development during rapid isometric contractions of varying intensities
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Baseline
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The slope of the rate-of-force development scaling factor (RFD-SF)
Time Frame: After 3 weeks
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The slope of the relationship (RFD-SF) between muscle force and rate of force development during rapid isometric contractions of varying intensities
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After 3 weeks
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The slope of the rate-of-force development scaling factor (RFD-SF)
Time Frame: After 6 weeks
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The slope of the relationship (RFD-SF) between muscle force and rate of force development during rapid isometric contractions of varying intensities
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After 6 weeks
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The slope of the rate-of-force development scaling factor (RFD-SF)
Time Frame: After 9 weeks
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The slope of the relationship (RFD-SF) between muscle force and rate of force development during rapid isometric contractions of varying intensities
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After 9 weeks
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Motor Evoked Potentials (MEP)
Time Frame: Baseline
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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.
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Baseline
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Motor Evoked Potentials (MEP)
Time Frame: After 3 weeks
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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
|
Motor Evoked Potentials (MEP)
Time Frame: After 6 weeks
|
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.
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After 6 weeks
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Motor Evoked Potentials (MEP)
Time Frame: After 9 weeks
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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.
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After 9 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The linearity of the rate-of-force development scaling factor (RFD-SF) relationship
Time Frame: Baseline
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The linearity, described by coefficient of determination (r-squared) of the relationship (RFD-SF) between muscle force and rate of force
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Baseline
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The linearity of the rate-of-force development scaling factor (RFD-SF) relationship
Time Frame: After 3 weeks
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The linearity, described by coefficient of determination (r-squared) of the relationship (RFD-SF) between muscle force and rate of force
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After 3 weeks
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The linearity of the rate-of-force development scaling factor (RFD-SF) relationship
Time Frame: After 6 weeks
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The linearity, described by coefficient of determination (r-squared) of the relationship (RFD-SF) between muscle force and rate of force
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After 6 weeks
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The linearity of the rate-of-force development scaling factor (RFD-SF) relationship
Time Frame: After 9 weeks
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The linearity, described by coefficient of determination (r-squared) of the relationship (RFD-SF) between muscle force and rate of force
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After 9 weeks
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M-wave
Time Frame: Baseline
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The tracing of the earliest electromyography (EMG) response to the stimulation of femoral nerve
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Baseline
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M-wave
Time Frame: After 3 weeks
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The tracing of the earliest electromyography (EMG) response to the stimulation of femoral nerve
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After 3 weeks
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M-wave
Time Frame: After 6 weeks
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The tracing of the earliest electromyography (EMG) response to the stimulation of femoral nerve
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After 6 weeks
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M-wave
Time Frame: After 9 weeks
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The tracing of the earliest electromyography (EMG) response to the stimulation of femoral nerve
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After 9 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 9, 2018
Primary Completion (Actual)
June 15, 2018
Study Completion (Actual)
June 15, 2018
Study Registration Dates
First Submitted
November 2, 2020
First Submitted That Met QC Criteria
November 5, 2020
First Posted (Actual)
November 10, 2020
Study Record Updates
Last Update Posted (Actual)
November 10, 2020
Last Update Submitted That Met QC Criteria
November 5, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 02-672-2/09-04-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Data will be available after a request to PI
IPD Sharing Time Frame
Six months after the completion of the study
IPD Sharing Access Criteria
No specific sharing access criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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