Quadriceps Muscle FunctionNCT04624438
Central and Peripheral Changes in Quadriceps Femoris Function After Different Types of Isometric Strength Training
A study testing Isometric training with electromyostimulation, Isometric training with voluntary activation and Isometric training with combination of electromyostimulation and voluntary activation in people with Quadriceps Muscle Function, run by University of Belgrade at 1 site in Serbia.
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. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Quadriceps Muscle Function
- What is being tested?
- Isometric training with electromyostimulation, Isometric training with voluntary activation and Isometric training with combination of electromyostimulation and voluntary activation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSerbia
- Study dates
- 9 Apr 2018to 15 Jun 2018
- 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 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- young healthy, physically active participants of both genders
Who cannot join
- no history of injuries, muscle-skeletal or neurological disease, or medications intake
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Faculty of Sport and Physical Education, University of Belgrade
Belgrade, 11030
About this study
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.
Read the 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.
- Conditions
- Quadriceps Muscle Function
- Being tested
- Isometric training with electromyostimulation, Isometric training with voluntary activation, Isometric training with combination of electromyostimulation and voluntary activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric training with electromyostimulationOther
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 activationOther
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 activationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Electromyostimulation - EMS | Experimental | Experimental group comprised of healthy young adults that undergoes unilateral isometric training using electromyostimulation over quadriceps femoris Receives: Other: Isometric training with electromyostimulation |
| Voluntary activation - VOLUNTARY | Experimental | Experimental group comprised of healthy young adults that undergoes unilateral isometric training based on voluntary activation of quadriceps femoris Receives: Other: Isometric training with voluntary activation |
| Combination of EMS and VOLUNTARY - COMBINED | Experimental | Experimental group comprised of healthy young adults that undergoes unilateral isometric training that combines electromyostimulation and voluntary activation of quadriceps femoris. Receives: Other: Isometric training with combination of electromyostimulation and voluntary activation |
| Control group - CONTROL | No intervention | Group of healthy young adults who received no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MVC
Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort
Measured: Baseline
MVC
Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort
Measured: After 3 weeks
MVC
Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort
Measured: After 6 weeks
MVC
Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort
Measured: After 9 weeks
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
Measured: Baseline
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
Measured: After 3 weeks
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
Measured: After 6 weeks
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
Measured: After 9 weeks
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.
Measured: Baseline
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.
Measured: After 3 weeks
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.
Measured: After 6 weeks
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.
Measured: After 9 weeks
Secondary outcomes (8)
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
Measured: Baseline
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
Measured: After 3 weeks
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
Measured: After 6 weeks
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
Measured: After 9 weeks
M-wave
The tracing of the earliest electromyography (EMG) response to the stimulation of femoral nerve
Measured: Baseline
M-wave
The tracing of the earliest electromyography (EMG) response to the stimulation of femoral nerve
Measured: After 3 weeks
M-wave
The tracing of the earliest electromyography (EMG) response to the stimulation of femoral nerve
Measured: After 6 weeks
M-wave
The tracing of the earliest electromyography (EMG) response to the stimulation of femoral nerve
Measured: After 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start9 Apr 2018
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadriceps Muscle FunctionStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Collaborators
- University of Primorska, Faculty of Health Sciences
- Responsible party
- Principal investigator, Dragan Mirkov, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624438
- Sponsor's protocol ID
- 02-672-2/09-04-2015
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available after a request to PI
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central and Peripheral Changes in Quadriceps Femoris Function After Different Types of Isometric Strength Training
- ClinicalTrials.gov ID
- NCT04624438
- Acronym / sponsor ID
- 02-672-2/09-04-2015
- Conditions
- Quadriceps Muscle Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Collaborators
- University of Primorska, Faculty of Health Sciences
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 10 Nov 2020 (actual)
- 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 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Electromyostimulation - EMS | Experimental | Other: Isometric training with electromyostimulationExperimental group comprised of healthy young adults that undergoes unilateral isometric training using electromyostimulation over quadriceps femoris |
| Voluntary activation - VOLUNTARY | Experimental | Other: Isometric training with voluntary activationExperimental group comprised of healthy young adults that undergoes unilateral isometric training based on voluntary activation of quadriceps femoris |
| Combination of EMS and VOLUNTARY - COMBINED | Experimental | Other: Isometric training with combination of electromyostimulation and voluntary activationExperimental group comprised of healthy young adults that undergoes unilateral isometric training that combines electromyostimulation and voluntary activation of quadriceps femoris. |
| Control group - CONTROL | No intervention | –Group of healthy young adults who received no intervention. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- young healthy, physically active participants of both genders
Key exclusion criteria (1 listed)
- no history of injuries, muscle-skeletal or neurological disease, or medications intake
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 |
|---|---|---|
| Isometric training with electromyostimulationEach 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. | Other | Electromyostimulation - EMS |
| Isometric training with voluntary activationEach 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. | Other | Voluntary activation - VOLUNTARY |
| Isometric training with combination of electromyostimulation and voluntary activationEach 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. | Other | Combination of EMS and VOLUNTARY - COMBINED |
Primary outcome
MVC
Time frame: Baseline
Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort
MVC
Time frame: After 3 weeks
Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort
MVC
Time frame: After 6 weeks
Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort
MVC
Time frame: After 9 weeks
Maximal isometric force and Rate of Force Development of quadriceps femoris muscle during isometric contractions with maximal effort
The slope of the rate-of-force development scaling factor (RFD-SF)
Time frame: Baseline
The slope of the relationship (RFD-SF) between muscle force and rate of force development during rapid isometric contractions of varying intensities
The slope of the rate-of-force development scaling factor (RFD-SF)
Time frame: After 3 weeks
The slope of the relationship (RFD-SF) between muscle force and rate of force development during rapid isometric contractions of varying intensities
The slope of the rate-of-force development scaling factor (RFD-SF)
Time frame: After 6 weeks
The slope of the relationship (RFD-SF) between muscle force and rate of force development during rapid isometric contractions of varying intensities
The slope of the rate-of-force development scaling factor (RFD-SF)
Time frame: After 9 weeks
The slope of the relationship (RFD-SF) between muscle force and rate of force development during rapid isometric contractions of varying intensities
Motor Evoked Potentials (MEP)
Time frame: Baseline
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.
Motor Evoked Potentials (MEP)
Time frame: After 3 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.
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.
Motor Evoked Potentials (MEP)
Time frame: After 9 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.
8 secondary outcomes
The linearity of the rate-of-force development scaling factor (RFD-SF) relationship
Time frame: Baseline
The linearity of the rate-of-force development scaling factor (RFD-SF) relationship
Time frame: After 3 weeks
The linearity of the rate-of-force development scaling factor (RFD-SF) relationship
Time frame: After 6 weeks
The linearity of the rate-of-force development scaling factor (RFD-SF) relationship
Time frame: After 9 weeks
M-wave
Time frame: Baseline
M-wave
Time frame: After 3 weeks
M-wave
Time frame: After 6 weeks
M-wave
Time frame: After 9 weeks
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 10 Nov 2020.
- Individual participant dataSharing planned: Yes. Data will be available after a request to PI
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric training with electromyostimulation, Isometric training with voluntary activation and Isometric training with combination of electromyostimulation and voluntary activation in people with Quadriceps Muscle Function, run by University of Belgrade at 1 site in Serbia.
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 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
MVC (time frame: Baseline). The study lists 12 primary outcomes in all. 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 10 Nov 2020.