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Electrical StimulationNCT05905406

Effect of Femoral Quadriceps Muscle Length on Fatigue Induced by Neuromuscular Electrical Stimulation

A study testing Electrical estimulation in people with Electrical Stimulation, run by University of Brasilia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims To investigate the effects of Quadriceps femoris muscle length on neuromuscular fatigue induced by NMES, muscle performance, discomfort and peripheral oxygen extraction. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Electrical Stimulation
What is being tested?
Electrical estimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
30 Jun 2023to 30 Jun 2024
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants between 18 and 45 years of age;
  • Both sexes;
  • Healthy;
  • Body mass index (BMI) between 18.5 and 24.9 kg/ m² (ie eutrophic);
  • Who did not perform systematic training strengthening of the lower limbs in the last six months;
  • Practitioners or not of recreational sports activities;
  • Physically active according to the International Physical Activity Questionnaire (IPAQ);
  • Who with minimum torque reach of 20% of MVC during NMES without excessive discomfort.

Who cannot join

  • Edema;
  • Dermal injury;
  • Limitation of the range of joint motion;
  • Deformity or amputation in any part of the lower limbs, as well as a history of patellar dislocation or trauma to the lower limbs or trunk that compromises the results;
  • Those with conditions that affect musculotendineal morphology or neuromuscular excitability such as diabetes mellitus type II, familial hypercholesterolemia, neuromuscular disease and severe cardiopathy;
  • Conditions that make it impossible to cooperate with procedures, such as cognitive impairment, psychiatric illness, chemical dependence or behavioral problems.

Trial locations and contacts

No sites are listed yet.

Victor H.S Ribeiro, master's student contact

61981325828 ext. +55

victorhugo.dsribeiro@gmail.com

João L.Q Durigan, PhD contact

5561981408621 ext. +55

joaodurigan@gmail.com

About this study

Official title: Effect of Femoral Quadriceps Muscle Length on Fatigue, Neuromuscular Performance, Oxygen Uptake and Discomfort Induced by Neuromuscular Electrical Stimulation

This study aims To investigate the effects of Quadriceps femoris muscle length on neuromuscular fatigue induced by NMES, muscle performance, discomfort and peripheral oxygen extraction.

Read the detailed description

This is a crossover, experimental, randomized and double-blind trial (participant and statistician). The procedures will be performed at the Neuromuscular Performance Laboratory and the Musculotendineal Plasticity Laboratory (LaPlasT) of the Faculty of Ceilândia/University of Brasília to evaluate the neuromuscular fatigue generated during NMES of the QF muscle in different muscle lengths, according to the articular angles of the hip and knee. Participants aged between 18 and 45 years of age, of both sexes, healthy, with body mass index (BMI) between 18.5 and 24.9 kg/ m² (ie eutrophic), who did not perform systematic training to strengthen the lower limbs in the last six months, practitioners or not of recreational sports activities, physically active according to the International Physical Activity Questionnaire (IPAQ), and with minimum torque reach of 20% of MVC during NMES without excessive discomfort. Those who have: edema, dermal injury, limitation of the range of joint motion, deformity or amputation in any part of the lower limbs, as well as a history of patellar dislocation or trauma to the lower limbs or trunk that compromises the results. Also excluded are those with conditions that affect musculotendineal morphology or neuromuscular excitability such as diabetes mellitus type II, familial hypercholesterolemia, neuromuscular disease and severe cardiopathy, or conditions that procedures, such as cognitive impairment, psychiatric disease, chemical dependence or behavioral problems (Dudley-Javoroski et al., 2010). Participants will be initially familiar with assessments and training with EENM. In familiarization, will be performed: Antropometry (height and body mass); location of the motor points; randomization of the order of articular positioning that will be evaluated; muscle enhancement; and three CVIM. The fatigue protocol with NMES will occur at 20% of MVC in positions: bench press with knee at 60º of flexion (Sup60), sitting with knee at 60º (Sen60), bench press at 20º (Sup20) and Sitting with knee at 20º (Sen20). These positions were chosen considering that: (1) SJ60 is the position in which the knee angle provides the optimal QF length for maximum torque production (Scott et al., 2019), and the hip angle provides a neutral length for the RF (Bampouras et al., 2017); (2) QF is commonly stimulated with knees fully extended (Fitzgerald et al., 2003). However, with the knees extended, it is not possible to measure the extensor torque of the knee properly in the isokinetic dynamometer (Babault et al., 2003). Therefore, we chose 20º knee flexion as an approximate position; (3) the hip angle affects the length of RF and myotendinous stiffness of QF (Bampouras et al., 2017), so the knee angles (60º and 20º) will be evaluated with the participants both seated (hip in flexion; 85º) when lying down (hip in extension; 0º). During familiarization, for anthropometric assessment (height, body mass and BMI), participants will be barefoot and wearing light clothes. The BMI will be obtained by the ratio of the weight of the participants in kilos with the square of the height (kg/m2). To determine the level of engagement in physical activities, the IPAQ will be applied, which contains 7 items that assess the frequency (days) and duration (minutes and/ or hours) spent on physical activities in the last week (Scholes et al., 2016). After familiarization, there will be four sessions of fatigue induced by NMES, composed of 20 electrically induced contractions at 20% of CVM (CEI20%). Each session will be as confirmed by the volunteer regarding the absence of any residual muscle discomfort arising from the previous session. The sessions will be initiated with heating and muscle enhancement. The following outcomes will be observed before, during and after the fatigue protocol: CVIM; reflex H, Wave M and voluntary activation level; electromyographic activity; muscular architecture; tendinous properties and tissue oxygen extraction. During the fatigue protocol (five first and five last evoked contractions, will be evaluated: (1) fatigability by the torque decay curve; (2) integral force-time; (3) tissue extraction of oxygen.

Being tested
Electrical estimulation
Keywords
Electrical Stimulation, Fatigue, Electromyographic activity, Muscular architecture, Tendinous properties, Extraction of oxygen
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrical estimulationOther

    Electrical estimulation during the fatigue protocol. Frequency = 100 Hz, pulse duration = 500 µs, time ON = 20 s (including rise time = 1.0 s and descent time = 1.0 s) and off time = 20 sec

Study groups in NCT05905406
Study groupRoleWhat they receive
S60ExperimentalThe Hip will be positioned at 80°, and knee positioned 60°. The sessions will be initiated with heating and muscle enhancement. The following outcomes will be observed before and after the fatigue protocol: (1) CVIM; (2) voluntary activation level; (3) electromyographic activity; (4) muscular architecture; and (5) tendinous properties. During the fatigue protocol, except for item 1), will be evaluated: (1) fatigue by torque decay curve; (2) integral force-time; (3) muscular architecture; (4) tendinous properties; and tissue oxygen extraction.
Receives: Other: Electrical estimulation
S20ExperimentalThe Hip will be positioned at 80°, and knee positioned 20°. The sessions will be initiated with heating and muscle enhancement. The following outcomes will be observed before and after the fatigue protocol: (1) CVIM; (2) voluntary activation level; (3) electromyographic activity; (4) muscular architecture; and (5) tendinous properties. During the fatigue protocol, except for item 1), will be evaluated: (1) fatigue by torque decay curve; (2) integral force-time; (3) muscular architecture; (4) tendinous properties; and tissue oxygen extraction.
Receives: Other: Electrical estimulation
D60ExperimentalThe Hip will be positioned at 0°, and knee positioned 60°. The sessions will be initiated with heating and muscle enhancement. The following outcomes will be observed before and after the fatigue protocol: (1) CVIM; (2) voluntary activation level; (3) electromyographic activity; (4) muscular architecture; and (5) tendinous properties. During the fatigue protocol, except for item 1), will be evaluated: (1) fatigue by torque decay curve; (2) integral force-time; (3) muscular architecture; (4) tendinous properties; and tissue oxygen extraction.
Receives: Other: Electrical estimulation
D20ExperimentalThe Hip will be positioned at 0°, and knee positioned 20°. The sessions will be initiated with heating and muscle enhancement. The following outcomes will be observed before and after the fatigue protocol: (1) CVIM; (2) voluntary activation level; (3) electromyographic activity; (4) muscular architecture; and (5) tendinous properties. During the fatigue protocol, except for item 1), will be evaluated: (1) fatigue by torque decay curve; (2) integral force-time; (3) muscular architecture; (4) tendinous properties; and tissue oxygen extraction.
Receives: Other: Electrical estimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fatigue

    Fatigue index evoked by electrical stimulation

    Measured: an average of 1 year and half

Secondary outcomes (12)
  1. Reflex H

    Analysis of the physiologic variables

    Measured: an average of 1 year and half

  2. M wave

    Analysis of the physiologic variables

    Measured: an average of 1 year and half

  3. Voluntary activation level

    Analysis of the physiologic variables

    Measured: an average of 1 year and half

  4. Surface electromyographic activity (EMG)

    Level of activation of muscle

    Measured: an average of 1 year and half

  5. Muscle thickness

    Datas from Muscle architecture

    Measured: an average of 1 year and half

  6. Displacement of the tendon-aponeurosis complex

    Datas from Muscle architecture

    Measured: an average of 1 year and half

  7. Muscle stiffness

    Datas from Muscle architecture

    Measured: an average of 1 year and half

  8. Properties of the patellar tendon

    cross section area from patellar tendon

    Measured: an average of 1 year and half

  9. Oxidized hemoglobin (Oxy-[Hb/Mb])

    tissue extraction

    Measured: an average of 1 year and half

  10. Deoxidized hemoglobin (deoxy-[Hb/Mb])

    tissue extraction

    Measured: an average of 1 year and half

  11. Total hemoglobin (total-[Hb/Mb])

    tissue extraction

    Measured: an average of 1 year and half

  12. Sensorial discomfort during all phases in protocol

    Sensorial discomfort assessed by VAS

    Measured: an average of 1 year and half

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start30 Jun 2023 (estimated)
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05905406
Sponsor's protocol ID
68446223.2.0000.80
Status last verified
Jun 2023
First submitted
23 May 2023
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The authors consider sharing the data depending on the situation

Publications

  • Ando R, Nosaka K, Inami T, Tomita A, Watanabe K, Blazevich AJ, Akima H. Difference in fascicle behaviors between superficial and deep quadriceps muscles during isometric contractions. Muscle Nerve. 2016 May;53(5):797-802. doi: 10.1002/mus.24905. Epub 2016 Mar 1.

    PubMed 26355494
  • Babault N, Cometti G, Bernardin M, Pousson M, Chatard JC. Effects of electromyostimulation training on muscle strength and power of elite rugby players. J Strength Cond Res. 2007 May;21(2):431-7. doi: 10.1519/R-19365.1.

    PubMed 17530954
  • Blazevich AJ. Effects of physical training and detraining, immobilisation, growth and aging on human fascicle geometry. Sports Med. 2006;36(12):1003-17. doi: 10.2165/00007256-200636120-00002.

    PubMed 17123325
  • Cavalcante JGT, de Almeida Ventura A, de Jesus Ferreira LG, de Sousa AMM, de Sousa Neto IV, de Cassia Marqueti R, Babault N, Durigan JLQ. Hip and Knee Joint Angles Determine Fatigue Onset during Quadriceps Neuromuscular Electrical Stimulation. Appl Bionics Biomech. 2022 Jul 22;2022:4612867. doi: 10.1155/2022/4612867. eCollection 2022.

    PubMed 35937098
  • Cavalcante JGT, Marqueti RC, Geremia JM, de Sousa Neto IV, Baroni BM, Silbernagel KG, Bottaro M, Babault N, Durigan JLQ. The Effect of Quadriceps Muscle Length on Maximum Neuromuscular Electrical Stimulation Evoked Contraction, Muscle Architecture, and Tendon-Aponeurosis Stiffness. Front Physiol. 2021 Mar 29;12:633589. doi: 10.3389/fphys.2021.633589. eCollection 2021.

    PubMed 33854439
  • Herzog W, Abrahamse SK, ter Keurs HE. Theoretical determination of force-length relations of intact human skeletal muscles using the cross-bridge model. Pflugers Arch. 1990 Apr;416(1-2):113-9. doi: 10.1007/BF00370231.

    PubMed 2352828
  • Kubo K, Ohgo K, Takeishi R, Yoshinaga K, Tsunoda N, Kanehisa H, Fukunaga T. Effects of isometric training at different knee angles on the muscle-tendon complex in vivo. Scand J Med Sci Sports. 2006 Jun;16(3):159-67. doi: 10.1111/j.1600-0838.2005.00450.x.

    PubMed 16643193
  • Maffiuletti NA. Physiological and methodological considerations for the use of neuromuscular electrical stimulation. Eur J Appl Physiol. 2010 Sep;110(2):223-34. doi: 10.1007/s00421-010-1502-y. Epub 2010 May 15.

    PubMed 20473619
  • Raiteri BJ. Aponeurosis behaviour during muscular contraction: A narrative review. Eur J Sport Sci. 2018 Sep;18(8):1128-1138. doi: 10.1080/17461391.2018.1472299. Epub 2018 May 28.

    PubMed 29806988
  • Talbot LA, Gaines JM, Ling SM, Metter EJ. A home-based protocol of electrical muscle stimulation for quadriceps muscle strength in older adults with osteoarthritis of the knee. J Rheumatol. 2003 Jul;30(7):1571-8.

    PubMed 12858461
  • de Souza Ribeiro VH, de Jesus Ferreira LG, Geremia JM, de Souza Baptista R, Babault N, de Cassia Marqueti R, Durigan JLQ. Effect of knee and hip joint positions on passive stiffness of the rectus femoris and vastus lateralis in healthy individuals. Sci Rep. 2026 Sep 11;16(1):28463. doi: 10.1038/s41598-026-60808-z.

    PubMed 42728264

Questions about this trial

What is this clinical trial studying?

A study testing Electrical estimulation in people with Electrical Stimulation, run by University of Brasilia.

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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Victor H.S Ribeiro, master's student (61981325828 ext. +55, victorhugo.dsribeiro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue (time frame: an average of 1 year and half). 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 NCT05905406, which also lists 11 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 15 Jun 2023.

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