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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03225976
Other study ID # U1111-1143-7629
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 25, 2018
Est. completion date March 12, 2019

Study information

Verified date April 2021
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Background: Phototherapy is a therapeutic resource of increasing use in the last decade. The photobiomodulatory effects are produced by sources of low-level lasers or light- emitting diode (LEDT), and their tissue effects are equivalent. 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. Objective: To analyze the acute effects of the application of LED phototherapy on the strength and fatigue strength abilities of cycling athletes. Method: The study sample will be composed of 48 male cyclist athletes randomly allocated into three groups: Infrared LED Group (G-I), Red LED Group (G-V), Infrared plus Red Group (G-IV) and Sham Group (G-S). The athletes will be submitted to a battery of tests, for performance evaluation which consist of anaerobic and aerobic power and threshold, bioimpedance, infrared thermography, creatine kinase (CK) and blood lactate analysis, measurement of local muscle blood flow, Gas analysis, besides the isokinetic, electromyographic and biomechanical evaluations. After 24 hours of the tests, the LEDT (180 J) will be applied three times in three differents days to the quadriceps femoris muscle bilaterally. The same tests will be performed 24 hours after the application of LEDT. In the 1st and 4th week, post intervention, only the isokinetic and electromyographic evaluations will be performed. For analysis of the data, normality test will be used to verify the distribution and adequate statistical tests for the appropriate intra and intergroup comparisons, being considered two factors in the comparisons, time and group. A significance level of 5% will be adopte


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date March 12, 2019
Est. primary completion date December 25, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Carriers of Cardiorespiratory Diseases; - Users of anti-inflammatory and analgesic drugs - Users of Alcohol and illicit drugs

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Light-Emitting Diode Device
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.
Sham Light-Emitting Diode Device
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

Locations

Country Name City State
Brazil University of São Paulo Ribeirão Preto São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Strenght Capacities N/m Twenty minutes
Secondary Resistence Capacities Minutes Twenty Minutes
Secondary Muscle recruitment Hertz Twenty Minutes
Secondary Gas analysis ml.kg-1.min-1 Twenty Minutes
Secondary Lactate analysis mmol/L Twenty Minutes
Secondary Creatine Kinase Analysis IU/L Five Minutes
Secondary Thermography Celsius Degree Fifteen Minutes
Secondary Local blood flow mL/s Twenty Minutes
Secondary Power Watts Twenty Minutes
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