Effects of Light Emitting Diodes (LED) Therapy in Rugby Athletes

July 7, 2021 updated by: Universidade Estadual de Londrina

Analysis of Delayed Onset Muscle Soreness, Functional Performance, Inflammatory and Ergogenic Response of Light Emitting Diodes (LED) Therapy in Rugby Athletes

Therapy with light emitting diodes (LED) is a good resource to accelerate the recovery of the athlete and reduce muscle damage caused by exercise. Objective: To evaluate the effects of LED therapy applied at different times on late muscle pain (DOMS), functional performance, inflammatory and ergogenic response of rugby athletes. Methodology: Randomized crossover clinical trial, composed of three groups that will receive treatment with LED at three different times. Sample made up of rugby athletes of both sexes, aged between 18 and 35 years. On the first day of the study, there will be an anamnesis, where the participants will answer questions about personal data, history of injuries and training time, right after the participants receive weight, height, heart rate and measured blood pressure, in addition to collecting a blood sample. to standardize the individual's baseline values. After the initial assessment, participants will be randomized to not receive the LED (CO) or receive LED therapy at three different times: before (Lpré), in the interval (Lin) and after (Lpós) the performance tests. Then, the modified Star Trek Balance Test (SEBTm), the Single Jump Test (SGHT) and the Triple Jump Test (THT) will be performed. After that, the Bangsbo Sprint (BST) test will be performed, followed by the Yo-Yo level 1 intermittent recovery test (Yo-Yo IR1). At the end of this test, the subjects will remain at rest for 10 minutes and will be subjected to the same tests (BST and Yo-Yo IR1) again. They will be measured at the end of the second battery of tests, heart rate, blood pressure, subjective perception of effort, muscle pain threshold, blood samples collected and repeated functional tests. After 48 hours of the performance tests, the blood sample will be collected again, the functional tests carried out and they answered a Stress Recovery Questionnaire for Athletes (RESTQ-Sport-76). At 7, 14 and 21 days after the initial tests, the same test and evaluation protocol will be performed, but the participants will receive LED therapy before, during or after the performance tests, according to their randomization. LED therapy will be performed on the rectus femoris, vastus lateralis and vastus medialis muscles; bilateral femoral, semitendinosus and gastrocnemius biceps.

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

Randomized crossover clinical trial, composed of three groups that will receive LED treatment at three different times. Sample made up of rugby athletes of both sexes, aged between 18 and 35 years. On the first day of the study, there will be an anamnesis, in which the participants will answer questions about personal data, history of injuries and training time, right after receiving weight, height, heart rate and blood pressure, in addition to collecting a blood sample. standardize the baseline values of the individual. After the initial assessment, participants will be randomized to not receive the LED (CO) or receive LED therapy at three different times: before (Lpré), in the interval (Lin) and after (Lpós) of the performance tests. Then, the modified Star Trek Balance Test (SEBTm), the Single Jump Test (SGHT) and the Triple Jump Test (THT) will be performed. Soon after, the familiarization protocol with the Bangsbo Sprint test (BST) will begin, with the participants positioned close to the initial marker (photocell) and the signal, they must execute a maximum of 34.2 meters, performing seven repetitions, with twenty-five seconds duration for active recovery between sprints. At the end of the sprints, the participant will rest for 10 minutes and then perform the intermittent Yo-Yo level 1 recovery test (Yo-Yo IR1). At the end of this test, participants remain at rest for 10 minutes and then perform the same tests (BST and Yo-Yo IR1) again. At the end of the second battery of tests, heart rate, blood pressure, perceived exertion, blood sample and functional tests will be measured again. After 48 hours of performance tests, blood samples will be collected and functional tests will be carried out, in addition to all participants answering the Stress Recovery Questionnaire for Athletes (RESTQ-Sport-76), to quantify the recovery and psychophysiological stress during the test and recovery days. At 7, 14 and 21 days after the initial tests, the same test and evaluation protocol will be performed, but the participants will receive LED therapy before, during or after the performance tests, according to their randomization. All participants will receive LED therapy at the three times, only the application sequence will be randomized. LED therapy will be performed at two points on the quadriceps, two on the hamstrings and two on the gastrocnemius bilaterally. At each point, irradiation will be applied for 60 seconds, with a wavelength of 850nm (± 20nm) and an energy density of 8 joules per square centimeter (J/cm2).

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.
21

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
    • Paraná
      • Londrina, Paraná, Brazil, 86038-350
        • university hospital of the State University of Londrina

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 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals practicing rugby;
  • Juvenile and adult categories;
  • Minimum training of three days per week;
  • Without history of musculoskeletal injuries in the lower limbs in the last year;
  • Without the use of supplements or medicines.

Exclusion Criteria:

  • Injuries that make it impossible to perform the tests.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

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: Before
LED applications at the beginning, with a dose of 8 J/cm2, will be performed shortly after the blood collections, with a maximum period of 10 minutes, in which the participants of the other groups should remain in rest passive. At the end of these 10 minutes, a 5 minute warm up will be performed and then the tests will be started.
Device: LED before
Phototherapy will be applied through LED therapy equipment, with 15 light emitting diodes that produce 8 joules (J) per diode and 120 joules in total. The muscular regions irradiated will be the quadriceps, hamstrings and triceps sural, with two points of application in each muscle group.
Experimental: Interval
The LED therapy applied in the tests interval will be performed after the first block of tests, with a maximum duration of 10 minutes and dose of 8 J/cm2. Then the second block of maximum tests will be performed.
Device: LED interval
Phototherapy will be applied through LED therapy equipment, with 15 light emitting diodes that produce 8 joules per diode and 120 joules in total. The muscular regions irradiated will be the quadriceps, hamstrings and triceps sural, with two points of application in each muscle group.
Experimental: After
LED applications at the end will be performed 10 minutes after the second battery of tests, also with 8 J/cm2 and in the same muscles irradiated in the other moments of application.
Device: LED after
Phototherapy will be applied through LED therapy equipment, with 15 light emitting diodes that produce 8 joules per diode and 120 joules in total. The muscular regions irradiated will be the quadriceps, hamstrings and triceps sural, with two points of application in each muscle group.
No Intervention: Baseline
On that day, participants will not receive any intervention.

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
Changes in creatine kinase
Time Frame: Before, immediately after and after 48 hours.
Analysis of inflammatory and cellular lesion responses with creatine kinase (IU/L) test.
Before, immediately after and after 48 hours.
Bangsbo sprint test
Time Frame: During the performance protocol and fatigue performed once a week for four weeks.
To quantify the performance of rugby players in the Bangsbo sprint test (seconds).
During the performance protocol and fatigue performed once a week for four weeks.
Yo-Yo Intermittent Recovery Test
Time Frame: During the performance protocol and fatigue performed once a week for four weeks.
To quantify the performance of rugby players in the Yo-Yo Intermittent Recovery Test (meters).
During the performance protocol and fatigue performed once a week for four weeks.

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
Functional performance in the Star Excursion Balance Test
Time Frame: Before, immediately after and after 48 hours.
Measure the distance (centimeters) reached with each lower limb in the Star Excursion Balance Test modified.
Before, immediately after and after 48 hours.
Functional performance in Single Hop Test and Triple Hop Test
Time Frame: Before, immediately after and after 48 hours.
Measure the distance (centimeters) reached with each lower limb in the Single Hop Test and in the Triple Hop Test.
Before, immediately after and after 48 hours.
Recovery and psychophysiological stress
Time Frame: 48 hours after performance tests
Will be applied the questionnaire Recovery-Stress Questionnaire for Athletes translated and validated for Portuguese language with the objective of evaluating recovery and psychophysiological stress. Consists of 19 scales (General Stress, Emotional Stress, Social Stress, Conflicts / Pressure, Fatigue, Lack of Energy, Complaints Somatic, Success, Social Recovery, Physical Recovery, General Welfare, Sleep Quality, Intervals, Emotional Exhaustion, Injuries, Fitness, Self Acceptance, Self-Efficacy and Self-Regulation), with four questions on each scale, totaling 76 questions. The values of the scales are calculated by the mean values of the items, which can vary from 0 to 6. High scores on the scales associated with stress activities reflect intense subjective stress, while high scores on the scales associated with recovery reflect many recovery activities.
48 hours after performance tests
Changes in blood lactate
Time Frame: Before, immediately after the second Yoyo IR1 and 10 minutes after the end of this test.
Analysis of effort intensity during performance tests
Before, immediately after the second Yoyo IR1 and 10 minutes after the end of this test.

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.
Universidade Estadual de Londrina

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

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.
February 1, 2019

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.
September 10, 2019

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.
November 30, 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).
October 3, 2018

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.
October 29, 2018

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.
November 2, 2018

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.
July 13, 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.
July 7, 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.
July 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.
  • Recovery in rugby athletes

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

product manufactured in and exported from the U.S.

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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