TorqueNCT03653286
Neuromuscular Eletroestimulation in Torque for Long Distance Recreational Runners
A study testing NMES and Run and Only Run in people with Torque, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial summary
Introduction: The use of neuromuscular electrical stimulation (NMES) in athlete training has become an increasingly common feature among competition teams. Among the main benefits of NMES are the increase in muscular strength and improvement in athletes' performance. Read more about this study
- Who is it for?
- Ages 30 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Torque
- What is being tested?
- NMES and Run and Only Run
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Sep 2018to 21 Sep 2019
- 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 30 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Included will be male individuals, aged 30 to 45 years
- recreational funders, who have been performing the activity for at least 1 year.
- Totaling at least 15km and a maximum of 40km of training per week,
- Who do not use NMES for the purpose of muscle training.
Who cannot join
- Subjects who present muscle injuries and / or joint injuries in the lower limbs (LMI) in the last 6 months can't be part of the study.
- Who are unable to perform the isokinetic test
- Who are unable to do ergospirometric test,
- Who meet the contraindications criteria of NMES
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Physical Training With Neuromuscular Eletroestimulation in Torque and Performance of Long Distance Recreational Runners Randomized Clinical Trial
Introduction: The use of neuromuscular electrical stimulation (NMES) in athlete training has become an increasingly common feature among competition teams. Among the main benefits of NMES are the increase in muscular strength and improvement in athletes' performance. Surveys demonstrate the benefits of basketball, volleyball, soccer, swimmers and Olympic lifters using NMES, but no studies have been conducted on runners. Objectives: To evaluate the effects of 6 weeks of training with NMES, on knee peak torque (PT), ventilatory anaerobic threshold, maximum oxygen consumption (VO2max) and running economy in recreational runners. Methods: Randomized clinical trial involving 30 long distance runners, being randomly distributed in 2 groups of 15 participants each. All individuals will perform isokinetic evaluation of the lower limbs and ergospirometry. After these evaluations, all athletes will perform the same running training (CT), in addition to the CT the intervention group will perform NMES on the knee extensors 3 times a week for 15 minutes.
Read the detailed description
Participants who meet the eligibility criteria will be invited to participate in the study and, after signing the informed consent form, will perform initial clinical evaluation and will be randomized into two groups, being: control group (CG) and intervention group (GI) - using the medium-frequency alternating current. Each group will consist of 15 subjects who will have as dependent variables, the evaluation of the following items: peak muscle torque, analysis of ventilatory anaerobic thresholds, running economy and maximal oxygen consumption.
The intervention with the NMES will be considered as an independent variable. All groups will have the dependent variables evaluated before and after the intervention, which will consist of 18 sessions (6 weeks). The NMES training will be performed 3 times a week and will never be applied for two consecutive days, as shown in the flowchart All individuals, being they of the CG or the GI will perform a running training (TC), between 15 and 40 km per week and will be guided how to perform them, and the GI patients will perform a muscle strengthening protocol with NMES, which will be carried out in a specific place and prepared for intervention, in addition to the TC.
- Conditions
- Torque
- Being tested
- NMES and Run, Only Run
- Keywords
- Neuromuscular Eletrical Stimulation, Torque, Runners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMES and RunOther
NMESIn this exercise protocol for quadriceps strengthening using NMES, the medium-frequency alternating current (1KHz with 10% of the work cycle) 4 will be used. The total daily training time is 900sec (15min), it is expected to perform 45 contractions per training, with three workouts per week for six weeks.
RUN: It will be allowed to carry out training drills that comprise 15-40Km per week, being allowed a minimum of 2 and a maximum of 3 training sessions per week, not being able to carry out drills of explosion and during each training must be covered at least 5km and at most 15km. These limitations were based on the American College of Sports Medicine (ACSM) cardiorespiratory training guidelines to minimize confounders of cardiopulmonary performance.
Only RunOther
RUN: It will be allowed to carry out training drills that comprise 15-40Km per week, being allowed a minimum of 2 and a maximum of 3 training sessions per week, not being able to carry out drills of explosion and during each training must be covered at least 5km and at most 15km. These limitations were based on the American College of Sports Medicine (ACSM) cardiorespiratory training guidelines to minimize confounders of cardiopulmonary performance.
| Study group | Role | What they receive |
|---|---|---|
| NMES and Run | Experimental | NMES and run Receives: Other: NMES and Run |
| Only Run | Other | Only Run Receives: Other: Only Run |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic dynamometer
The computerized isokinetic muscle evaluation will be performed in the Cybex Norm isokinetic dynamometer (Cybex International, Inc., Ronkonkoma, LI, New York), at the Physiotherapy Clinic of Universidade Cidade de São Paulo (UNICID). The movement performed during the test will be that of isometric, concentric and eccentric extension of the two knees, to measure peak torque, using angulations of 90 to 60 degrees of knee and 3 maximum voluntary contractions.
Measured: 6 weeks
Secondary outcomes (3)
Maximum oxygen consumption
Prior to the test, subjects will lie down for 10 minutes for initial ventilatory data and heart rate (HR) records. The test protocol will consist of running on a treadmill (ATL Model, Inbrasport Ltda, Brazil), with an initial velocity of 6km / h, followed by increments of 1km / h every 1min until voluntary exhaustion of the subjects.
Ventilatory parameters will be collected during rest and continuously throughout the tests, at each respiratory cycle, and analyzed in averages of 20sec through a computerized gas analyzer (model VO2000; Inbrasport Ltda, Brazil). The gas analyzer shall be calibrated to the volume and standard concentration of gases immediately before the first test of the day and re-calibrated after each test as per manufacturer's standardization.
Measured: 6 weeks
Racing economy
The running economy on a horizontal treadmill will be measured in 3 speeds in the order indicated: 2.68, 3.13 and 3.58 m · s-1 (9.6, 11.3 and 12.9 km · h-1, respectively). The guy will run for 6 minutes at each speed and rest between runs. The VO2 per minute will be measured during each of the last 3 minutes of each race. The mean of the difference of the 2 values will be used as a measure of the running economy.
The economy will be expressed in meters per milliliter of oxygen consumed per kilogram of body weight (m / ml-1 / kg-1). This unit allows comparisons at various running speeds, and has a conceptual advantage in that the numerical values are directly related to the economy (ie, the higher the number the better the economy).
Measured: 6 weeks
Analysis of Ventilatory Anaerobic Threshold
The LAVs will be determined from ventilatory equivalents (VE / VO2 and VE / VCO2), final expired fractions (FEO2 and FECO2) and respiratory quotient (QR), and expressed as VO2 (in ml / kg / min). The LAV1 will correspond to the lowest value of EV / VO2 before its continuous increase associated with the beginning of the abrupt and continuous increase of the QR.
The LAV2 will correspond to the point at which the nonlinear increases of VE / VO2, VE / VCO2 and FEO2 will coincide with the decrease of FECO2. Immediately after the 18th training session, the patients will be re-evaluated and submitted to all the procedures described for isokinetic evaluation and ergospirometry.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start19 Sep 2018
- Primary completion25 Jul 2019
- Study completion21 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TorqueStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The runners will be randomized into two groups, being: control group (CG) - will perform only run and intervention group (GI) - using the medium-frequency alternating current and run.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Eloin Liebano, Universidade Cidade de Sao Paulo
- Investigators
- Richard E Liebano, Study director, Universidade Cidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653286
- Sponsor's protocol ID
- UNICIDAGRREM14
- Status last verified
- Oct 2019
- First submitted
- 26 Aug 2018
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Training With Neuromuscular Eletroestimulation in Torque and Performance of Long Distance Recreational Runners Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03653286
- Acronym / sponsor ID
- UNICIDAGRREM14
- Conditions
- Torque
- Keywords
- Neuromuscular Eletrical Stimulation, Torque, Runners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 21 Sep 2019 (actual)
- First posted
- 31 Aug 2018 (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.
Introduction: The use of neuromuscular electrical stimulation (NMES) in athlete training has become an increasingly common feature among competition teams. Among the main benefits of NMES are the increase in muscular strength and improvement in athletes' performance. Surveys demonstrate the benefits of basketball, volleyball, soccer, swimmers and Olympic lifters using NMES, but no studies have been conducted on runners. Objectives: To evaluate the effects of 6 weeks of training with NMES, on knee peak torque (PT), ventilatory anaerobic threshold, maximum oxygen consumption (VO2max) and running economy in recreational runners. Methods: Randomized clinical trial involving 30 long distance runners, being randomly distributed in 2 groups of 15 participants each. All individuals will perform isokinetic evaluation of the lower limbs and ergospirometry. After these evaluations, all athletes will perform the same running training (CT), in addition to the CT the intervention group will perform NMES on the knee extensors 3 times a week for 15 minutes.
Detailed description
Participants who meet the eligibility criteria will be invited to participate in the study and, after signing the informed consent form, will perform initial clinical evaluation and will be randomized into two groups, being: control group (CG) and intervention group (GI) - using the medium-frequency alternating current. Each group will consist of 15 subjects who will have as dependent variables, the evaluation of the following items: peak muscle torque, analysis of ventilatory anaerobic thresholds, running economy and maximal oxygen consumption.
The intervention with the NMES will be considered as an independent variable. All groups will have the dependent variables evaluated before and after the intervention, which will consist of 18 sessions (6 weeks). The NMES training will be performed 3 times a week and will never be applied for two consecutive days, as shown in the flowchart All individuals, being they of the CG or the GI will perform a running training (TC), between 15 and 40 km per week and will be guided how to perform them, and the GI patients will perform a muscle strengthening protocol with NMES, which will be carried out in a specific place and prepared for intervention, in addition to the TC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The runners will be randomized into two groups, being: control group (CG) - will perform only run and intervention group (GI) - using the medium-frequency alternating current and run.
| Arm | Type | Receives |
|---|---|---|
| NMES and Run | Experimental | Other: NMES and RunNMES and run |
| Only Run | Other | Other: Only RunOnly Run |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Included will be male individuals, aged 30 to 45 years
- recreational funders, who have been performing the activity for at least 1 year.
- Totaling at least 15km and a maximum of 40km of training per week,
- Who do not use NMES for the purpose of muscle training.
Key exclusion criteria (4 listed)
- Subjects who present muscle injuries and / or joint injuries in the lower limbs (LMI) in the last 6 months can't be part of the study.
- Who are unable to perform the isokinetic test
- Who are unable to do ergospirometric test,
- Who meet the contraindications criteria of NMES
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 |
|---|---|---|
| NMES and RunNMESIn this exercise protocol for quadriceps strengthening using NMES, the medium-frequency alternating current (1KHz with 10% of the work cycle) 4 will be used. The total daily training time is 900sec (15min), it is expected to perform 45 contractions per training, with three workouts per week for six weeks. RUN: It will be allowed to carry out training drills that comprise 15-40Km per week, being allowed a minimum of 2 and a maximum of 3 training sessions per week, not being able to carry out drills of explosion and during each training must be covered at least 5km and at most 15km. These limitations were based on the American College of Sports Medicine (ACSM) cardiorespiratory training guidelines to minimize confounders of cardiopulmonary performance. | Other | NMES and Run |
| Only RunRUN: It will be allowed to carry out training drills that comprise 15-40Km per week, being allowed a minimum of 2 and a maximum of 3 training sessions per week, not being able to carry out drills of explosion and during each training must be covered at least 5km and at most 15km. These limitations were based on the American College of Sports Medicine (ACSM) cardiorespiratory training guidelines to minimize confounders of cardiopulmonary performance. | Other | Only Run |
Primary outcome
Isokinetic dynamometer
Time frame: 6 weeks
The computerized isokinetic muscle evaluation will be performed in the Cybex Norm isokinetic dynamometer (Cybex International, Inc., Ronkonkoma, LI, New York), at the Physiotherapy Clinic of Universidade Cidade de São Paulo (UNICID). The movement performed during the test will be that of isometric, concentric and eccentric extension of the two knees, to measure peak torque, using angulations of 90 to 60 degrees of knee and 3 maximum voluntary contractions.
3 secondary outcomes
Maximum oxygen consumption
Time frame: 6 weeks
Racing economy
Time frame: 6 weeks
Analysis of Ventilatory Anaerobic Threshold
Time frame: 6 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 5 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Richard E Liebano study director
Universidade Cidade de Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES and Run and Only Run in people with Torque, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
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 4 inclusion and 4 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 5 Nov 2019. 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 Brazil. 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?
Isokinetic dynamometer (time frame: 6 weeks). 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 5 Nov 2019.