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

Primary Purpose

Electrical Stimulation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electrical estimulation
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Electrical Stimulation focused on measuring Electrical Stimulation, Fatigue, Electromyographic activity, Muscular architecture, Tendinous properties, Extraction of oxygen

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    S60

    S20

    D60

    D20

    Arm Description

    The 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.

    The 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.

    The 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.

    The 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.

    Outcomes

    Primary Outcome Measures

    Fatigue
    Fatigue index evoked by electrical stimulation

    Secondary Outcome Measures

    Reflex H
    Analysis of the physiologic variables
    M wave
    Analysis of the physiologic variables
    Voluntary activation level
    Analysis of the physiologic variables
    Surface electromyographic activity (EMG)
    Level of activation of muscle
    Muscle thickness
    Datas from Muscle architecture
    Displacement of the tendon-aponeurosis complex
    Datas from Muscle architecture
    Muscle stiffness
    Datas from Muscle architecture
    Properties of the patellar tendon
    cross section area from patellar tendon
    Oxidized hemoglobin (Oxy-[Hb/Mb])
    tissue extraction
    Deoxidized hemoglobin (deoxy-[Hb/Mb])
    tissue extraction
    Total hemoglobin (total-[Hb/Mb])
    tissue extraction
    Sensorial discomfort during all phases in protocol
    Sensorial discomfort assessed by VAS

    Full Information

    First Posted
    May 23, 2023
    Last Updated
    June 7, 2023
    Sponsor
    University of Brasilia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05905406
    Brief Title
    Effect of Femoral Quadriceps Muscle Length on Fatigue Induced by Neuromuscular Electrical Stimulation
    Official Title
    Effect of Femoral Quadriceps Muscle Length on Fatigue, Neuromuscular Performance, Oxygen Uptake and Discomfort Induced by Neuromuscular Electrical Stimulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 30, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2023 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Brasilia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Electrical Stimulation
    Keywords
    Electrical Stimulation, Fatigue, Electromyographic activity, Muscular architecture, Tendinous properties, Extraction of oxygen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    S60
    Arm Type
    Experimental
    Arm Description
    The 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.
    Arm Title
    S20
    Arm Type
    Experimental
    Arm Description
    The 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.
    Arm Title
    D60
    Arm Type
    Experimental
    Arm Description
    The 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.
    Arm Title
    D20
    Arm Type
    Experimental
    Arm Description
    The 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.
    Intervention Type
    Other
    Intervention Name(s)
    Electrical estimulation
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Fatigue
    Description
    Fatigue index evoked by electrical stimulation
    Time Frame
    an average of 1 year and half
    Secondary Outcome Measure Information:
    Title
    Reflex H
    Description
    Analysis of the physiologic variables
    Time Frame
    an average of 1 year and half
    Title
    M wave
    Description
    Analysis of the physiologic variables
    Time Frame
    an average of 1 year and half
    Title
    Voluntary activation level
    Description
    Analysis of the physiologic variables
    Time Frame
    an average of 1 year and half
    Title
    Surface electromyographic activity (EMG)
    Description
    Level of activation of muscle
    Time Frame
    an average of 1 year and half
    Title
    Muscle thickness
    Description
    Datas from Muscle architecture
    Time Frame
    an average of 1 year and half
    Title
    Displacement of the tendon-aponeurosis complex
    Description
    Datas from Muscle architecture
    Time Frame
    an average of 1 year and half
    Title
    Muscle stiffness
    Description
    Datas from Muscle architecture
    Time Frame
    an average of 1 year and half
    Title
    Properties of the patellar tendon
    Description
    cross section area from patellar tendon
    Time Frame
    an average of 1 year and half
    Title
    Oxidized hemoglobin (Oxy-[Hb/Mb])
    Description
    tissue extraction
    Time Frame
    an average of 1 year and half
    Title
    Deoxidized hemoglobin (deoxy-[Hb/Mb])
    Description
    tissue extraction
    Time Frame
    an average of 1 year and half
    Title
    Total hemoglobin (total-[Hb/Mb])
    Description
    tissue extraction
    Time Frame
    an average of 1 year and half
    Title
    Sensorial discomfort during all phases in protocol
    Description
    Sensorial discomfort assessed by VAS
    Time Frame
    an average of 1 year and half

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Victor H.S Ribeiro, master's student
    Phone
    61981325828
    Ext
    +55
    Email
    victorhugo.dsribeiro@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    João L.Q Durigan, PhD
    Phone
    5561981408621
    Ext
    +55
    Email
    joaodurigan@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The authors consider sharing the data depending on the situation
    Citations:
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    26355494
    Citation
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    Effect of Femoral Quadriceps Muscle Length on Fatigue Induced by Neuromuscular Electrical Stimulation

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