NCT03225976

Brief Summary

Phototherapy is a therapeutic resource of increasing use in the last decade. The photobiomodulatory effects are commonly produced by means of low intensity lasers or LED emitting diodes, and can be used at different wavelengths. These light sources are divergent as to coherence, but produce equivalent tissue effects. The application of laser or LED light is able to induce biochemical changes in tissues, allowing for inhibitory or stimulating effects. These responses are associated to a cascade of cellular reactions, which favor the absorption of enzymes by cytochrome c oxidase, generating physiological responses that lead to decreased production of reactive oxygen species and increased synthesis of adenosine triphosphate (ATP). The application of this therapeutic resource brings ergogenic and protective benefits in muscular performance. The use of LED as a light source is promising because of its low cost, but there are no enough studies that support this use in athletes, with a focus on performance improvement. In addition to the deficiency of the sample, there is also no consensus regarding the use of different wavelengths for LED in the literature, thus opening gaps for the best protocol for the application of this technique. Therefore, a study that evaluates the use of LED in athletes, with different wavelengths, to improve performance is necessary. Hypothesis: It is hypothesized that the LED application is capable of improving athletes performance in terms of increased fatigue resistance, increased strength and power, increased muscle recruitment, and optimized oxygen demand. It is also expected that the results generated in this study can contribute to and increase the resources used by physiotherapists within the clinical-sports field, contributing to the post-training recovery, as well as the more effective physical performance in competitive activities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

July 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2019

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

July 19, 2017

Last Update Submit

April 28, 2021

Conditions

Keywords

PhototherapyAthletic PerformanceMuscle StrengthFatigue

Outcome Measures

Primary Outcomes (1)

  • Strenght Capacities

    N/m

    Twenty minutes

Secondary Outcomes (8)

  • Resistence Capacities

    Twenty Minutes

  • Muscle recruitment

    Twenty Minutes

  • Gas analysis

    Twenty Minutes

  • Lactate analysis

    Twenty Minutes

  • Creatine Kinase Analysis

    Five Minutes

  • +3 more secondary outcomes

Study Arms (4)

Infrared LED group (G-I)

EXPERIMENTAL

The Light-Emitting Diode Device with wavelength of 904nm will be applied throughout the quadriceps femoralis extension bilaterally.

Device: Light-Emitting Diode Device

Red LED group (G-V)

EXPERIMENTAL

The Light-Emitting Diode Device with a wavelength of 620nm will be applied throughout the quadriceps femoralis extension bilaterally.

Device: Light-Emitting Diode Device

Sham Group (G-S)

SHAM COMPARATOR

The Sham Light-Emitting Diode Device will be positioned throughout the quadriceps femoral muscle extension, however, there will be no light emission.

Device: Sham Light-Emitting Diode Device

Infrared plus Red LED group (G-IV)

EXPERIMENTAL

The Light-Emitting Diode Device with a wavelength of 620nm plus 904nm will be applied throughout the quadriceps femoralis extension bilaterally.

Device: Light-Emitting Diode Device

Interventions

The therapy will be applied on the second, third and fourth day of collection using a 25x40 cm2 LED blanket, with an equidistant distribution, with total energy per area of 180 J bilaterally on the quadriceps femoris muscle. All LEDs will be calibrated prior to the start of applications in the Laboratory of Photobiophysics of the Faculty of Sciences and Letters of Ribeirão Preto, University of São Paulo, in which the wavelengths will be checked, the angle of radiation, power and power density.

Infrared LED group (G-I)Infrared plus Red LED group (G-IV)Red LED group (G-V)

The Sham Light-Emitting Diode Device will be applied on the second, third and fourth day of collection using a 25x40 cm2 LED blanket, with an equidistant distribution, with total energy per area of 0 J bilaterally on the quadriceps femoris muscle. At the time of application the device will not be activated

Sham Group (G-S)

Eligibility Criteria

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

You may qualify if:

  • Cycling practitioners
  • Age between 18 and 45 years;
  • Male
  • VO2MÁX \> 40 ml.kg-1.min-1;
  • Absence of musculoskeletal injury in the last six months

You may not qualify if:

  • Carriers of Cardiorespiratory Diseases;
  • Users of anti-inflammatory and analgesic drugs
  • Users of Alcohol and illicit drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

Ribeirão Preto, São Paulo, Brazil

Location

Related Publications (2)

  • Ferraresi C, Huang YY, Hamblin MR. Photobiomodulation in human muscle tissue: an advantage in sports performance? J Biophotonics. 2016 Dec;9(11-12):1273-1299. doi: 10.1002/jbio.201600176. Epub 2016 Nov 22.

  • de Carvalho G, Gobbi A, Gobbi RB, Alfredo DMN, do Carmo Furquim TH, Barbosa RI, Papoti M, de Jesus Guirro RR. Photobiomodulation by light emitting diode applied sequentially does not alter performance in cycling athletes. Lasers Med Sci. 2020 Oct;35(8):1769-1779. doi: 10.1007/s10103-020-02973-9. Epub 2020 Feb 20.

Related Links

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rinaldo RJ Roberto de Jesus Guirro, Dr

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Athletes will be randomized allocated the following groups: * Infrared LED group (G-I; n = 12) * Red LED group (G-V; n = 12) * Infrared plus Red LED group (G-IV; n = 12) * Sham Group (G-S; n = 12)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctoral

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 21, 2017

Study Start

January 25, 2018

Primary Completion

December 25, 2018

Study Completion

March 12, 2019

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations