NCT05905406

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

Same day

First QC Date

May 23, 2023

Last Update Submit

June 7, 2023

Conditions

Electrical Stimulation

Keywords

Electrical StimulationFatigueElectromyographic activityMuscular architectureTendinous propertiesExtraction of oxygen

Outcome Measures

Primary Outcomes (1)

  • Fatigue

    Fatigue index evoked by electrical stimulation

    an average of 1 year and half

Secondary Outcomes (12)

  • Reflex H

    an average of 1 year and half

  • M wave

    an average of 1 year and half

  • Voluntary activation level

    an average of 1 year and half

  • Surface electromyographic activity (EMG)

    an average of 1 year and half

  • Muscle thickness

    an average of 1 year and half

  • +7 more secondary outcomes

Study Arms (4)

S60

EXPERIMENTAL

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.

Other: Electrical estimulation

S20

EXPERIMENTAL

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.

Other: Electrical estimulation

D60

EXPERIMENTAL

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.

Other: Electrical estimulation

D20

EXPERIMENTAL

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.

Other: Electrical estimulation

Interventions

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

D20D60S20S60

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 26355494BACKGROUND

  • 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.

    PMID: 17530954BACKGROUND

  • 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.

    PMID: 17123325BACKGROUND

  • 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.

    PMID: 35937098BACKGROUND

  • 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.

    PMID: 33854439BACKGROUND

  • 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.

    PMID: 2352828BACKGROUND

  • 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.

    PMID: 16643193BACKGROUND

  • 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.

    PMID: 20473619BACKGROUND

  • 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.

    PMID: 29806988BACKGROUND

  • 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.

    PMID: 12858461BACKGROUND

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Victor H.S Ribeiro, master's student

CONTACT

61981325828victorhugo.dsribeiro@gmail.com

João L.Q Durigan, PhD

CONTACT

5561981408621joaodurigan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist Assistant Professor

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 15, 2023

Study Start

June 30, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2024

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

The authors consider sharing the data depending on the situation