- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07602933
Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES
Effects of Photobiomodulation on Fatigue and Muscle Damage Induced by Neuromuscular Electrical Stimulation in Healthy Individuals: a Randomized Clinical Trial
A tanulmány áttekintése
Állapot
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Marco A Vaz, PhD
- Telefonszám: +555133085853
- E-mail: marco.vaz@ufrgs.br
Tanulmányi helyek
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazília, 90690200
- Toborzás
- Laboratório de Pesquisa do Exercício
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Kapcsolatba lépni:
- Jeam M Geremia, PhD
- Telefonszám: 5133085853
- E-mail: jeam.geremia@ufrgs.br
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Kutatásvezető:
- Marco A Vaz, PhD
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Alkutató:
- Gustavo N Petter, MSc
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: Photobiomodulation (PBM)
Participants in this arm will receive active photobiomodulation therapy.
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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.
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).
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Sham Comparator: Sham PBM
Participants in this arm will receive an inactive (placebo) photobiomodulation treatment.
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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).
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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Maximal voluntary isometric contraction (MVIC)
Időkeret: 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).
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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).
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Evoked fatigue
Időkeret: Continuously during the 20-minute fatigue protocol.
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Fall in the evoked torque during the fatigue protocol.
Unit of Measure: Newton-meters (N.m)
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Continuously during the 20-minute fatigue protocol.
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Muscle Echo Intensity
Időkeret: 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).
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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).
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Pressure Pain Threshold
Időkeret: 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).
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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)
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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).
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Quadriceps Muscle Thickness
Időkeret: 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).
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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).
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Countermovement Jump (CMJ) Height
Időkeret: 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).
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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).
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Lower Limb Joint Kinematics During Jump
Időkeret: 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).
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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).
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Force-Time Curve Dynamics During Jump
Időkeret: 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).
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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)
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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).
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Muscle Activation
Időkeret: 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).
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Surface electromyography (sEMG) to assess muscle activation amplitude during MVIC.
Unit of Measure: Microvolts (uV)
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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).
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Vastus Lateralis Fascicle Length
Időkeret: Continuously during the 20-minute fatigue protocol on Day 1.
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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.
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Vastus Lateralis Pennation Angle
Időkeret: Continuously during the 20-minute fatigue protocol on Day 1.
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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.
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Adipose Tissue Thickness
Időkeret: Baseline
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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)
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Baseline
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Együttműködők és nyomozók
Nyomozók
- Tanulmányi szék: Marco A Vaz, PhD, Federal University of Rio Grande do Sul
- Tanulmányi igazgató: Marco A Vaz, PhD, Federal University of Rio Grande do Sul
- Kutatásvezető: Marco A Vaz, PhD, Federal University of Rio Grande do Sul
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 5.309.992(1)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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