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Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES

15. května 2026 aktualizováno: Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul

Effects of Photobiomodulation on Fatigue and Muscle Damage Induced by Neuromuscular Electrical Stimulation in Healthy Individuals: a Randomized Clinical Trial

Neuromuscular electrical stimulation (NMES) is widely used to improve muscle strength and mitigate atrophy. However, its clinical efficacy is often limited by early neuromuscular fatigue, muscle damage, and discomfort, which reduce patient tolerance and contraction time. Photobiomodulation (PBM) has emerged as a potential therapy to enhance muscle performance and accelerate recovery by minimizing fatigue and damage. Despite its potential, few studies have investigated the effects of PBM applied specifically before an NMES-evoked fatigue protocol. This randomized, double-blind, placebo-controlled trial aims to evaluate the acute effects of PBM on neuromuscular fatigue, muscle damage, and functional outcomes in healthy young subjects. Participants will receive either active PBM (cluster probe: 5 lasers 810nm/200mW; 4 LEDs 660nm/10mW; Total Energy: 249.6 J per limb) or sham treatment 5 minutes before a fatiguing NMES protocol (80 contractions at 20% MVIC, 80 Hz, 1ms pulse width) applied to the quadriceps muscle. Assessments will be performed at baseline, immediately post-intervention, and at 24h, 48h, and 72h post-intervention. Primary outcomes include maximum and evoked isometric strength, mechanical work, and electrical muscle activity. Secondary outcomes include muscle damage (ultrasound echo-intensity), delayed onset muscle soreness (DOMS), functional performance (unilateral vertical jump), and clinical discomfort. The study seeks to determine if PBM can effectively modulate NMES-induced fatigue and muscle damage, potentially optimizing its clinical application.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

36

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Brazílie
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazílie, 90690200
        • Laboratório de Pesquisa do Exercício
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Marco A Vaz, PhD
        • Dílčí vyšetřovatel:
          • Gustavo N Petter, MSc

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion Criteria:

  • Healthy male and female volunteers.
  • Age between 18 and 45 years.
  • Practice physical activity regularly
  • No history of musculoskeletal injuries in the lower limbs in the last 6 months
  • Ability to tolerate NMES

Exclusion Criteria:

  • Have sensory intolerable changes due to NMES
  • Consumed coffee or another stimulant in the last 12 hours
  • Have a body mass index (BMI) greater than 30 kg/m2 (grade I obesity)
  • Present any contraindication for the performance of maximum effort
  • Abnormal increase in blood pressure after maximal exertion

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Photobiomodulation (PBM)
Participants in this arm will receive active photobiomodulation therapy.
Přístroj: Active Photobiomodulation
Application of PBMT using a cluster probe (Thor-DD2; 5 laser diodes: 810nm, 200mW; 4 LEDs: 660nm, 10mW). The treatment involves 8 points on the quadriceps (2 on vastus medialis, 3 on vastus lateralis, and 3 on rectus femoris). Each point is irradiated for 30 seconds in continuous mode with direct contact and slight pressure. Total energy: 31.2 J per point and 249.6 J per limb. Both therapist and participant will wear protective goggles.
Jiný: NMES-evoked fatigue protocol
Neuromuscular Electrical Stimulation (Myomed 932) applied to the quadriceps. Parameters: 80 Hz frequency, 1 ms pulse width (biphasic rectangular pulse), 5s:10s ON:OFF ratio with 1s ramp-up/down. The protocol lasts 20 minutes, totaling 80 evoked isometric contractions. Current intensity is adjusted to generate an initial torque of 20% of the baseline Maximum Voluntary Isometric Contraction (MVIC).
Falešný srovnávač: Sham PBM
Participants in this arm will receive an inactive (placebo) photobiomodulation treatment.
Jiný: NMES-evoked fatigue protocol
Neuromuscular Electrical Stimulation (Myomed 932) applied to the quadriceps. Parameters: 80 Hz frequency, 1 ms pulse width (biphasic rectangular pulse), 5s:10s ON:OFF ratio with 1s ramp-up/down. The protocol lasts 20 minutes, totaling 80 evoked isometric contractions. Current intensity is adjusted to generate an initial torque of 20% of the baseline Maximum Voluntary Isometric Contraction (MVIC).
Přístroj: Placebo Photobiomodulation
The procedure is identical to the active PBMT (8 points, 30 seconds per point, same pressure and positioning), but the device will be turned off. To ensure blinding, participants will wear protective goggles and a blindfold to prevent visual perception of the light.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Maximal voluntary isometric contraction (MVIC)
Časové okno: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Largest knee extensor torque generated isometrically and voluntarily on an isokinetic dynamometer.

Unit of Measure: Newton-meters (N.m)
Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Evoked fatigue
Časové okno: Continuously during the 20-minute fatigue protocol.
Fall in the evoked torque during the fatigue protocol. Unit of Measure: Newton-meters (N.m)
Continuously during the 20-minute fatigue protocol.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Muscle Echo Intensity
Časové okno: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Quantitative analysis of muscle ultrasound images to assess changes in echo intensity, reflecting acute edema and changes in muscle quality. Analysis will be performed specifically on the Rectus Femoris (RF), Vastus Medialis (VM), and Vastus Lateralis (VL).

Unit of Measure: Arbitrary Units (au) on a 0-255 grayscale
Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Pressure Pain Threshold
Časové okno: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
The minimum pressure at which a subject perceives a stimulus as painful, measured via pressure algometry on the quadriceps muscle bellies to quantify delayed onset muscle soreness (DOMS). Unit of Measure: Newtons (N)
Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Quadriceps Muscle Thickness
Časové okno: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Ultrasound assessment of structural changes in the quadriceps muscle group, for the Rectus Femoris (RF), Vastus Medialis (VM), and Vastus Lateralis (VL). This variable evaluates acute morphological changes or edema-induced swelling following the NMES protocol.

Unit of Measure: Millimeters (mm)
Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Countermovement Jump (CMJ) Height
Časové okno: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Measure Description: Maximum jump height achieved during a vertical countermovement jump on a force platform to assess dynamic muscle power.

Unit of Measure: Centimeters (cm)
Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Lower Limb Joint Kinematics During Jump
Časové okno: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).

Measure Description: Sagittal plane kinematic analysis for the ankle, knee, hip, and trunk joints to evaluate movement strategies and joint range of motion during the countermovement jump.

Unit of Measure: Degrees (°)
Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Force-Time Curve Dynamics During Jump
Časové okno: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Analysis of the vertical ground reaction force-time curve during the propulsion phase of the countermovement jump. The primary parameter will be the Vertical Impulse, calculated as the integral of force over time. Unit of Measure: Newton-seconds (N.s)
Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Muscle Activation
Časové okno: Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Surface electromyography (sEMG) to assess muscle activation amplitude during MVIC. Unit of Measure: Microvolts (uV)
Baseline (pre-intervention) on Day 1; immediately after the fatigue protocol on Day 1; and at 24, 48, and 72 hours after the fatigue protocol (on Days 2, 3, and 4, respectively).
Vastus Lateralis Fascicle Length
Časové okno: Continuously during the 20-minute fatigue protocol on Day 1.

Measure Description: Assessment of real-time changes in the fascicle length of the Vastus Lateralis muscle during the fatigue protocol using continuous ultrasound imaging.

Unit of Measure: Millimeters (mm)
Continuously during the 20-minute fatigue protocol on Day 1.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Vastus Lateralis Pennation Angle
Časové okno: Continuously during the 20-minute fatigue protocol on Day 1.

Measure Description: Assessment of real-time changes in the pennation angle of the Vastus Lateralis muscle during the fatigue protocol using continuous ultrasound imaging.

Unit of Measure: Degrees (°)
Continuously during the 20-minute fatigue protocol on Day 1.
Adipose Tissue Thickness
Časové okno: Baseline
Measurement of the fat layer thickness overlying the Rectus Femoris, Vastus Medialis, and Vastus Lateralis using ultrasound imaging. This measure is used to characterize the sample's morphology and will serve as a covariate to adjust the delivered PBM dose and NMES current penetration analysis. Unit of Measure: Millimeters (mm)
Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Federal University of Rio Grande do Sul

Spolupracovníci

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Vyšetřovatelé

  • Studijní židle: Marco A Vaz, PhD, Federal University of Rio Grande do Sul
  • Ředitel studie: Marco A Vaz, PhD, Federal University of Rio Grande do Sul
  • Vrchní vyšetřovatel: Marco A Vaz, PhD, Federal University of Rio Grande do Sul

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

30. srpna 2026

Dokončení studie (Odhadovaný)

30. září 2026

Termíny zápisu do studia

První předloženo

27. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

15. května 2026

První zveřejněno (Aktuální)

22. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 5.309.992(1)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

A final decision regarding the sharing of individual participant data has not yet been made. The study team intends to evaluate this possibility following the primary data analysis, in accordance with institutional guidelines and ethical committee requirements.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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