Effect of Light-Emitting Diode on the Strenght and Resistence Capacities of Cycling Athletes

April 28, 2021 updated by: Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Infrared LED group (G-I)
The Light-Emitting Diode Device with wavelength of 904nm will be applied throughout the quadriceps femoralis extension bilaterally.
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.
Experimental: Red LED group (G-V)
The Light-Emitting Diode Device with a wavelength of 620nm will be applied throughout the quadriceps femoralis extension bilaterally.
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 Comparator: Sham Group (G-S)
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
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
Experimental: Infrared plus Red LED group (G-IV)
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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Strenght Capacities
Time Frame: Twenty minutes
N/m
Twenty minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resistence Capacities
Time Frame: Twenty Minutes
Minutes
Twenty Minutes
Muscle recruitment
Time Frame: Twenty Minutes
Hertz
Twenty Minutes
Gas analysis
Time Frame: Twenty Minutes
ml.kg-1.min-1
Twenty Minutes
Lactate analysis
Time Frame: Twenty Minutes
mmol/L
Twenty Minutes
Creatine Kinase Analysis
Time Frame: Five Minutes
IU/L
Five Minutes
Thermography
Time Frame: Fifteen Minutes
Celsius Degree
Fifteen Minutes
Local blood flow
Time Frame: Twenty Minutes
mL/s
Twenty Minutes
Power
Time Frame: Twenty Minutes
Watts
Twenty Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rinaldo RJ Roberto de Jesus Guirro, Dr, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 25, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U1111-1143-7629

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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