Electrical StimulationNCT03905772
Neuromuscular Adaptations After Training in the Muscle Belly of Triceps Surae
A study testing Voluntary exercise, Wide pulse responder group and Wide pulse non responder group in people with Electrical Stimulation, run by University of Brasilia at 1 site in Brazil.
Trial summary
This study aims to evaluate on an acute session of the central and peripheral contributions of electrical stimulation on the muscle belly of the triceps surae, electrical stimulation of the tibial nerve and voluntary exercise of the triceps surae muscle, and identify responders individuals and non-responders to… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Electrical Stimulation
- What is being tested?
- Voluntary exercise, Wide pulse responder group and Wide pulse non responder group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Apr 2019to 1 Dec 2023
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Classified as physically active according to the INTERNATIONAL QUESTIONNAIRE OF PHYSICAL ACTIVITY,
- To practice only recreational physical activity,
- Achieve minimum torque of 30% of the (maximal voluntary isometric contraction during conventional NMES
- Be at least 3 months without practicing strength training.
Who cannot join
- Present some type of skeletal muscle dysfunction that may interfere with the tests,
- Present intolerance to NMES in the muscular or tibial nerve, Make use of analgesics, antidepressants, tranquillizers or other agents of central action
- To present cardiovascular or peripheral vascular problems, chronic diseases, neurological or muscular affections that will undermine the complete execution of the study design by the volunteer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular Adaptations After Training With Neuromuscular Electrical Stimulation Applied Over Nerve Trunk Compared With a Muscle Belly of Triceps Surae: Randomized Controlled Trial
This study aims to evaluate on an acute session of the central and peripheral contributions of electrical stimulation on the muscle belly of the triceps surae, electrical stimulation of the tibial nerve and voluntary exercise of the triceps surae muscle, and identify responders individuals and non-responders to stimulation of the tibial nerve. Another objective of the study is to compare the effects of conventional electrical stimulation applied to the sciatic triceps muscle, tibial nerve stimulation and voluntary exercise after eight weeks of training in healthy individuals.
Read the detailed description
A controlled randomized controlled trial will be carried out by university students, divided equally into four groups: control group (GC), long responding pulse group (PLR), non-responder long pulse group (PLNR) and pulsed current group (CP) after the acute fase of the protocol. Muscular architecture (muscle thickness, pennation angle and fascicle length) of the muscles composing the sural triceps, H-reflex and M-wave tests (central and peripheral contribution), electromyographic signals of the medial and lateral gastrocnemius muscles and sole, voluntary and evoked joint torque of the muscles composing the sural triceps and level of sensorial discomfort. The independent intervention with the neuromuscular electrical stimulation and the isometric exercises performed by the control group will be considered as an independent variable. All groups will have the dependent variables evaluated 6 times, before, during and after the intervention, which will consist of 24 sessions (8 weeks). The training with neuromuscular electrical stimulation (NMES) will be performed 3 times a week and will never be applied for two consecutive days, as well as the voluntary exercises performed by the control group.
- Conditions
- Electrical Stimulation
- Being tested
- Voluntary exercise, Wide pulse responder group, Wide pulse non responder group, Pulsed current group
- Keywords
- Electrical stimulation, M wave, H reflex, Wide pulse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voluntary exerciseOther
The participants will perform 36 maximal voluntary contractions, 3 times per week for 8 weeks.
Wide pulse responder groupOther
The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. This group will be classified in responder group in acute fase.
Wide pulse non responder groupOther
The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. This group will be classified in non responder group in acute fase.
Pulsed current groupOther
The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 250 μs, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Voluntary exercise | Experimental | The participants will perform 36 voluntary contractions of 20% of maximal voluntary isometrical contraction, 3 times per week for 8 weeks. Receives: Other: Voluntary exercise |
| Wide pulse responder group | Experimental | The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks.
This group will classified in responder in the acute fase. Receives: Other: Wide pulse responder group |
| Wide pulse non responder group | Experimental | The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks.
This group will classified in non responder in the acute fase. Receives: Other: Wide pulse non responder group |
| Pulsed current group | Experimental | The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 250 μs, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. Receives: Other: Pulsed current group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Central contribution (H reflex) after 15 minutes of acute session of electrical stimulation.
Central contribution will be measured before and after 15 minutes (36 contractions) of electrical stimulation in the acute session.
Measured: Baseline and after 15 minutes of electrical stimulation in the acute session.
Change from Baseline Central contribution (H reflex) after 8 weeks of training with electrical stimulation.
Central contribution will be measured before and after 8 weeks of training with electrical stimulation.
Measured: Baseline and after 8 weeks of training with electrical stimulation.
Change from Baseline Peripheral contribution (M wave) after 15 minutes of acute session of electrical stimulation
Peripheral contribution will be measured before and after acute session 15 minutes (36 contractions) of electrical stimulation in the acute session.
Measured: Baseline and after 15 minutes of electrical stimulation in the acute session
Change from Baseline Peripheral contribution (M wave) after 8 weeks of traning with electrical atimulation
Peripheral contribution will be measured before and after 8 weeks of training with electrical stimulation.
Measured: Baseline and after 8 weeks of training with electrical stimulation
Change from Baseline Voluntary torque after 8 weeks of training with electrical stimulation
Voluntary torque will be evaluated by an isokinetic dynamometer before and after an 8-week training period with electrical stimulation.
Measured: Baseline and after 8 weeks of training with electrical stimulation
Change from Baseline Electromyographic signals after 8 weeks of training with electrical stimulation
Electromyographic signals will be evaluated by an electromyography before and after an 8-week training period with electrical stimulation.
Measured: Baseline and after 8 weeks of training with electrical stimulation
Secondary outcomes (2)
Change from Baseline Evoked torque after 8 weeks of training with electrical stimulation
Evoked torque will be evaluated by an isokinetic dynamometer before and after an 8-week training period with electrical stimulation.
Measured: Baseline and after 8 weeks of training with electrical stimulation
Change from Baseline Discomfort sensory after 8 weeks of training with electrical stimulation
Discomfort sensory will be evaluated by Visual Analogic Scale before and after an 8-week training period with electrical stimulation. The Visual Analogic Scale assess pain by rating the subjective perceived disconfort of the subject from 0 (no pain) to 10 (unbearable pain)
Measured: Baseline and after 8 weeks of training with electrical stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start15 Apr 2019
- Primary completion1 May 2020
- Study completion1 Dec 2023 (estimated)
Why it stopped: Dr. Karenina has to change for another projetct due to Covid pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Electrical StimulationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Burgundy
- Responsible party
- Principal investigator, João Luiz Q. Durigan, University of Brasilia
- Investigators
- João Durigan, PhD, Study director, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905772
- Sponsor's protocol ID
- 01326818.8.0000.8093
- Status last verified
- May 2023
- First submitted
- 11 Mar 2019
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dirks ML, Hansen D, Van Assche A, Dendale P, Van Loon LJ. Neuromuscular electrical stimulation prevents muscle wasting in critically ill comatose patients. Clin Sci (Lond). 2015 Mar;128(6):357-65. doi: 10.1042/CS20140447.
PubMed 25296344Chae J, Sheffler L, Knutson J. Neuromuscular electrical stimulation for motor restoration in hemiplegia. Top Stroke Rehabil. 2008 Sep-Oct;15(5):412-26. doi: 10.1310/tsr1505-412.
PubMed 19008202Brocherie F, Babault N, Cometti G, Maffiuletti N, Chatard JC. Electrostimulation training effects on the physical performance of ice hockey players. Med Sci Sports Exerc. 2005 Mar;37(3):455-60. doi: 10.1249/01.mss.0000155396.51293.9f.
PubMed 15741845Billot M, Martin A, Paizis C, Cometti C, Babault N. Effects of an electrostimulation training program on strength, jumping, and kicking capacities in soccer players. J Strength Cond Res. 2010 May;24(5):1407-13. doi: 10.1519/JSC.0b013e3181d43790.
PubMed 20386476Medeiros FV, Bottaro M, Vieira A, Lucas TP, Modesto KA, Bo APL, Cipriano G Jr, Babault N, Durigan JLQ. Kilohertz and Low-Frequency Electrical Stimulation With the Same Pulse Duration Have Similar Efficiency for Inducing Isometric Knee Extension Torque and Discomfort. Am J Phys Med Rehabil. 2017 Jun;96(6):388-394. doi: 10.1097/PHM.0000000000000631.
PubMed 27680427Vaz MA, Baroni BM, Geremia JM, Lanferdini FJ, Mayer A, Arampatzis A, Herzog W. Neuromuscular electrical stimulation (NMES) reduces structural and functional losses of quadriceps muscle and improves health status in patients with knee osteoarthritis. J Orthop Res. 2013 Apr;31(4):511-6. doi: 10.1002/jor.22264. Epub 2012 Nov 8.
PubMed 23138532Gondin J, Brocca L, Bellinzona E, D'Antona G, Maffiuletti NA, Miotti D, Pellegrino MA, Bottinelli R. Neuromuscular electrical stimulation training induces atypical adaptations of the human skeletal muscle phenotype: a functional and proteomic analysis. J Appl Physiol (1985). 2011 Feb;110(2):433-50. doi: 10.1152/japplphysiol.00914.2010. Epub 2010 Dec 2.
PubMed 21127206Ward AR, Robertson VJ. The variation in fatigue rate with frequency using kHz frequency alternating current. Med Eng Phys. 2000 Nov;22(9):637-46. doi: 10.1016/s1350-4533(00)00085-0.
PubMed 11259932Ward AR, Chuen WL. Lowering of sensory, motor, and pain-tolerance thresholds with burst duration using kilohertz-frequency alternating current electric stimulation: part II. Arch Phys Med Rehabil. 2009 Sep;90(9):1619-27. doi: 10.1016/j.apmr.2009.02.022.
PubMed 19735792Ward AR, Robertson VJ, Ioannou H. The effect of duty cycle and frequency on muscle torque production using kilohertz frequency range alternating current. Med Eng Phys. 2004 Sep;26(7):569-79. doi: 10.1016/j.medengphy.2004.04.007.
PubMed 15271284Paillard T, Noe F, Bernard N, Dupui P, Hazard C. Effects of two types of neuromuscular electrical stimulation training on vertical jump performance. J Strength Cond Res. 2008 Jul;22(4):1273-8. doi: 10.1519/JSC.0b013e3181739e9c.
PubMed 18545178Filipovic A, Kleinoder H, Dormann U, Mester J. Electromyostimulation--a systematic review of the influence of training regimens and stimulation parameters on effectiveness in electromyostimulation training of selected strength parameters. J Strength Cond Res. 2011 Nov;25(11):3218-38. doi: 10.1519/JSC.0b013e318212e3ce.
PubMed 21993042Filipovic A, Kleinoder H, Dormann U, Mester J. Electromyostimulation--a systematic review of the effects of different electromyostimulation methods on selected strength parameters in trained and elite athletes. J Strength Cond Res. 2012 Sep;26(9):2600-14. doi: 10.1519/JSC.0b013e31823f2cd1.
PubMed 22067247Selkowitz DM, Rossman EG, Fitzpatrick S. Effect of burst-modulated alternating current carrier frequency on current amplitude required to produce maximally tolerated electrically stimulated quadriceps femoris knee extension torque. Am J Phys Med Rehabil. 2009 Dec;88(12):973-8. doi: 10.1097/PHM.0b013e3181c1eda5.
PubMed 19935181Binder-Macleod SA, Halden EE, Jungles KA. Effects of stimulation intensity on the physiological responses of human motor units. Med Sci Sports Exerc. 1995 Apr;27(4):556-65.
PubMed 7791587
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Adaptations After Training With Neuromuscular Electrical Stimulation Applied Over Nerve Trunk Compared With a Muscle Belly of Triceps Surae: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03905772
- Acronym / sponsor ID
- 01326818.8.0000.8093
- Conditions
- Electrical Stimulation
- Keywords
- Electrical stimulation, M wave, H reflex, Wide pulse
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Dr. Karenina has to change for another projetct due to Covid pandemic.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Collaborators
- University of Burgundy
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 5 Apr 2019 (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.
This study aims to evaluate on an acute session of the central and peripheral contributions of electrical stimulation on the muscle belly of the triceps surae, electrical stimulation of the tibial nerve and voluntary exercise of the triceps surae muscle, and identify responders individuals and non-responders to stimulation of the tibial nerve. Another objective of the study is to compare the effects of conventional electrical stimulation applied to the sciatic triceps muscle, tibial nerve stimulation and voluntary exercise after eight weeks of training in healthy individuals.
Detailed description
A controlled randomized controlled trial will be carried out by university students, divided equally into four groups: control group (GC), long responding pulse group (PLR), non-responder long pulse group (PLNR) and pulsed current group (CP) after the acute fase of the protocol. Muscular architecture (muscle thickness, pennation angle and fascicle length) of the muscles composing the sural triceps, H-reflex and M-wave tests (central and peripheral contribution), electromyographic signals of the medial and lateral gastrocnemius muscles and sole, voluntary and evoked joint torque of the muscles composing the sural triceps and level of sensorial discomfort. The independent intervention with the neuromuscular electrical stimulation and the isometric exercises performed by the control group will be considered as an independent variable. All groups will have the dependent variables evaluated 6 times, before, during and after the intervention, which will consist of 24 sessions (8 weeks). The training with neuromuscular electrical stimulation (NMES) will be performed 3 times a week and will never be applied for two consecutive days, as well as the voluntary exercises performed by the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Voluntary exercise | Experimental | Other: Voluntary exerciseThe participants will perform 36 voluntary contractions of 20% of maximal voluntary isometrical contraction, 3 times per week for 8 weeks. |
| Wide pulse responder group | Experimental | Other: Wide pulse responder groupThe participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. This group will classified in responder in the acute fase. |
| Wide pulse non responder group | Experimental | Other: Wide pulse non responder groupThe participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. This group will classified in non responder in the acute fase. |
| Pulsed current group | Experimental | Other: Pulsed current groupThe participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 250 μs, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Classified as physically active according to the INTERNATIONAL QUESTIONNAIRE OF PHYSICAL ACTIVITY,
- To practice only recreational physical activity,
- Achieve minimum torque of 30% of the (maximal voluntary isometric contraction during conventional NMES
- Be at least 3 months without practicing strength training.
Key exclusion criteria (3 listed)
- Present some type of skeletal muscle dysfunction that may interfere with the tests,
- Present intolerance to NMES in the muscular or tibial nerve, Make use of analgesics, antidepressants, tranquillizers or other agents of central action
- To present cardiovascular or peripheral vascular problems, chronic diseases, neurological or muscular affections that will undermine the complete execution of the study design by the volunteer.
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 |
|---|---|---|
| Voluntary exerciseThe participants will perform 36 maximal voluntary contractions, 3 times per week for 8 weeks. | Other | Voluntary exercise |
| Wide pulse responder groupThe participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. This group will be classified in responder group in acute fase. | Other | Wide pulse responder group |
| Wide pulse non responder groupThe participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. This group will be classified in non responder group in acute fase. | Other | Wide pulse non responder group |
| Pulsed current groupThe participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 250 μs, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. | Other | Pulsed current group |
Primary outcome
Change from Baseline Central contribution (H reflex) after 15 minutes of acute session of electrical stimulation.
Time frame: Baseline and after 15 minutes of electrical stimulation in the acute session.
Central contribution will be measured before and after 15 minutes (36 contractions) of electrical stimulation in the acute session.
Change from Baseline Central contribution (H reflex) after 8 weeks of training with electrical stimulation.
Time frame: Baseline and after 8 weeks of training with electrical stimulation.
Central contribution will be measured before and after 8 weeks of training with electrical stimulation.
Change from Baseline Peripheral contribution (M wave) after 15 minutes of acute session of electrical stimulation
Time frame: Baseline and after 15 minutes of electrical stimulation in the acute session
Peripheral contribution will be measured before and after acute session 15 minutes (36 contractions) of electrical stimulation in the acute session.
Change from Baseline Peripheral contribution (M wave) after 8 weeks of traning with electrical atimulation
Time frame: Baseline and after 8 weeks of training with electrical stimulation
Peripheral contribution will be measured before and after 8 weeks of training with electrical stimulation.
Change from Baseline Voluntary torque after 8 weeks of training with electrical stimulation
Time frame: Baseline and after 8 weeks of training with electrical stimulation
Voluntary torque will be evaluated by an isokinetic dynamometer before and after an 8-week training period with electrical stimulation.
Change from Baseline Electromyographic signals after 8 weeks of training with electrical stimulation
Time frame: Baseline and after 8 weeks of training with electrical stimulation
Electromyographic signals will be evaluated by an electromyography before and after an 8-week training period with electrical stimulation.
2 secondary outcomes
Change from Baseline Evoked torque after 8 weeks of training with electrical stimulation
Time frame: Baseline and after 8 weeks of training with electrical stimulation
Change from Baseline Discomfort sensory after 8 weeks of training with electrical stimulation
Time frame: Baseline and after 8 weeks of training with electrical stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Results publication: PubMed 25296344Dirks ML, Hansen D, Van Assche A, Dendale P, Van Loon LJ. Neuromuscular electrical stimulation prevents muscle wasting in critically ill comatose patients. Clin Sci (Lond). 2015 Mar;128(6):357-65. doi: 10.1042/CS20140447.
- Results publication: PubMed 19008202Chae J, Sheffler L, Knutson J. Neuromuscular electrical stimulation for motor restoration in hemiplegia. Top Stroke Rehabil. 2008 Sep-Oct;15(5):412-26. doi: 10.1310/tsr1505-412.
- Results publication: PubMed 15741845Brocherie F, Babault N, Cometti G, Maffiuletti N, Chatard JC. Electrostimulation training effects on the physical performance of ice hockey players. Med Sci Sports Exerc. 2005 Mar;37(3):455-60. doi: 10.1249/01.mss.0000155396.51293.9f.
- Results publication: PubMed 20386476Billot M, Martin A, Paizis C, Cometti C, Babault N. Effects of an electrostimulation training program on strength, jumping, and kicking capacities in soccer players. J Strength Cond Res. 2010 May;24(5):1407-13. doi: 10.1519/JSC.0b013e3181d43790.
- Results publication: PubMed 27680427Medeiros FV, Bottaro M, Vieira A, Lucas TP, Modesto KA, Bo APL, Cipriano G Jr, Babault N, Durigan JLQ. Kilohertz and Low-Frequency Electrical Stimulation With the Same Pulse Duration Have Similar Efficiency for Inducing Isometric Knee Extension Torque and Discomfort. Am J Phys Med Rehabil. 2017 Jun;96(6):388-394. doi: 10.1097/PHM.0000000000000631.
- Results publication: PubMed 23138532Vaz MA, Baroni BM, Geremia JM, Lanferdini FJ, Mayer A, Arampatzis A, Herzog W. Neuromuscular electrical stimulation (NMES) reduces structural and functional losses of quadriceps muscle and improves health status in patients with knee osteoarthritis. J Orthop Res. 2013 Apr;31(4):511-6. doi: 10.1002/jor.22264. Epub 2012 Nov 8.
- Results publication: PubMed 21127206Gondin J, Brocca L, Bellinzona E, D'Antona G, Maffiuletti NA, Miotti D, Pellegrino MA, Bottinelli R. Neuromuscular electrical stimulation training induces atypical adaptations of the human skeletal muscle phenotype: a functional and proteomic analysis. J Appl Physiol (1985). 2011 Feb;110(2):433-50. doi: 10.1152/japplphysiol.00914.2010. Epub 2010 Dec 2.
- Results publication: PubMed 11259932Ward AR, Robertson VJ. The variation in fatigue rate with frequency using kHz frequency alternating current. Med Eng Phys. 2000 Nov;22(9):637-46. doi: 10.1016/s1350-4533(00)00085-0.
- Results publication: PubMed 19735792Ward AR, Chuen WL. Lowering of sensory, motor, and pain-tolerance thresholds with burst duration using kilohertz-frequency alternating current electric stimulation: part II. Arch Phys Med Rehabil. 2009 Sep;90(9):1619-27. doi: 10.1016/j.apmr.2009.02.022.
- Results publication: PubMed 15271284Ward AR, Robertson VJ, Ioannou H. The effect of duty cycle and frequency on muscle torque production using kilohertz frequency range alternating current. Med Eng Phys. 2004 Sep;26(7):569-79. doi: 10.1016/j.medengphy.2004.04.007.
- Results publication: PubMed 18545178Paillard T, Noe F, Bernard N, Dupui P, Hazard C. Effects of two types of neuromuscular electrical stimulation training on vertical jump performance. J Strength Cond Res. 2008 Jul;22(4):1273-8. doi: 10.1519/JSC.0b013e3181739e9c.
- Results publication: PubMed 21993042Filipovic A, Kleinoder H, Dormann U, Mester J. Electromyostimulation--a systematic review of the influence of training regimens and stimulation parameters on effectiveness in electromyostimulation training of selected strength parameters. J Strength Cond Res. 2011 Nov;25(11):3218-38. doi: 10.1519/JSC.0b013e318212e3ce.
- 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.
João Durigan, PhD study director
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voluntary exercise, Wide pulse responder group and Wide pulse non responder group in people with Electrical Stimulation, run by University of Brasilia 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 3 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: paused, as of the sponsor's last update on 24 May 2023. 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?
Results are not available in the source record.
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?
Change from Baseline Central contribution (H reflex) after 15 minutes of acute session of electrical stimulation. (time frame: Baseline and after 15 minutes of electrical stimulation in the acute session.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03905772, which also lists 41 linked publications.
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 24 May 2023.