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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05905406
Other study ID # 68446223.2.0000.80
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 30, 2023
Est. completion date June 30, 2024

Study information

Verified date June 2023
Source University of Brasilia
Contact Victor H.S Ribeiro, master's student
Phone 61981325828
Email victorhugo.dsribeiro@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date June 30, 2024
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Electrical estimulation
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Brasilia

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fatigue Fatigue index evoked by electrical stimulation an average of 1 year and half
Secondary Reflex H Analysis of the physiologic variables an average of 1 year and half
Secondary M wave Analysis of the physiologic variables an average of 1 year and half
Secondary Voluntary activation level Analysis of the physiologic variables an average of 1 year and half
Secondary Surface electromyographic activity (EMG) Level of activation of muscle an average of 1 year and half
Secondary Muscle thickness Datas from Muscle architecture an average of 1 year and half
Secondary Displacement of the tendon-aponeurosis complex Datas from Muscle architecture an average of 1 year and half
Secondary Muscle stiffness Datas from Muscle architecture an average of 1 year and half
Secondary Properties of the patellar tendon cross section area from patellar tendon an average of 1 year and half
Secondary Oxidized hemoglobin (Oxy-[Hb/Mb]) tissue extraction an average of 1 year and half
Secondary Deoxidized hemoglobin (deoxy-[Hb/Mb]) tissue extraction an average of 1 year and half
Secondary Total hemoglobin (total-[Hb/Mb]) tissue extraction an average of 1 year and half
Secondary Sensorial discomfort during all phases in protocol Sensorial discomfort assessed by VAS an average of 1 year and half
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