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PhototherapyNCT03728439

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

A study testing LED before, LED interval and LED after in people with Phototherapy, run by Universidade Estadual de Londrina at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Phototherapy
What is being tested?
LED before, LED interval and LED after
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteBrazil
Study dates
1 Feb 2019to 30 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • Injuries that make it impossible to perform the tests.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • University Hospital of the State University of Londrina

    Londrina, Paraná, 86038-350

Other trials in Brazil

About this study

Official title: 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.

Read the 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).

Conditions
Phototherapy
Being tested
LED before, LED interval, LED after
Keywords
Recovery, Rugby, Phototherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LED beforeDevice

    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.

  • LED intervalDevice

    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.

  • LED afterDevice

    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.

Study groups in NCT03728439
Study groupRoleWhat they receive
BeforeExperimentalLED 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.
Receives: Device: LED before
IntervalExperimentalThe 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.
Receives: Device: LED interval
AfterExperimentalLED 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.
Receives: Device: LED after
BaselineNo interventionOn that day, participants will not receive any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in creatine kinase

    Analysis of inflammatory and cellular lesion responses with creatine kinase (IU/L) test.

    Measured: Before, immediately after and after 48 hours.

  2. Bangsbo sprint test

    To quantify the performance of rugby players in the Bangsbo sprint test (seconds).

    Measured: During the performance protocol and fatigue performed once a week for four weeks.

  3. Yo-Yo Intermittent Recovery Test

    To quantify the performance of rugby players in the Yo-Yo Intermittent Recovery Test (meters).

    Measured: During the performance protocol and fatigue performed once a week for four weeks.

Secondary outcomes (4)
  1. Functional performance in the Star Excursion Balance Test

    Measure the distance (centimeters) reached with each lower limb in the Star Excursion Balance Test modified.

    Measured: Before, immediately after and after 48 hours.

  2. Functional performance in Single Hop Test and Triple Hop Test

    Measure the distance (centimeters) reached with each lower limb in the Single Hop Test and in the Triple Hop Test.

    Measured: Before, immediately after and after 48 hours.

  3. Recovery and psychophysiological stress

    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.

    Measured: 48 hours after performance tests

  4. Changes in blood lactate

    Analysis of effort intensity during performance tests

    Measured: Before, immediately after the second Yoyo IR1 and 10 minutes after the end of this test.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2018
  2. Study start1 Feb 2019
  3. Primary completion10 Sep 2019
  4. Study completion30 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
This is a randomized crossover (crossover) trial. Participants will be randomized to not receive LED (CO) or have the application of LED therapy at three different times: before (Lpré), in the interval (Lin) and after (Lpós) of the Bangsbo and YoyoIR1 performance tests. At 7, 14 and 21 days after the initial tests, the same test and evaluation protocol will be performed. In addition, 48 hours after each test protocol, functional tests, recovery questionnaire and blood collection will be applied for analysis of creatine kinase.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03728439
Sponsor's protocol ID
Recovery in rugby athletes
Status last verified
Jul 2021
First submitted
3 Oct 2018
Last updated
13 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ferraresi C, Dos Santos RV, Marques G, Zangrande M, Leonaldo R, Hamblin MR, Bagnato VS, Parizotto NA. Light-emitting diode therapy (LEDT) before matches prevents increase in creatine kinase with a light dose response in volleyball players. Lasers Med Sci. 2015 May;30(4):1281-7. doi: 10.1007/s10103-015-1728-3. Epub 2015 Feb 27.

    PubMed 25722067
  • Leal-Junior EC, Vanin AA, Miranda EF, de Carvalho Pde T, Dal Corso S, Bjordal JM. Effect of phototherapy (low-level laser therapy and light-emitting diode therapy) on exercise performance and markers of exercise recovery: a systematic review with meta-analysis. Lasers Med Sci. 2015 Feb;30(2):925-39. doi: 10.1007/s10103-013-1465-4. Epub 2013 Nov 19.

    PubMed 24249354
  • Borsa PA, Larkin KA, True JM. Does phototherapy enhance skeletal muscle contractile function and postexercise recovery? A systematic review. J Athl Train. 2013 Jan-Feb;48(1):57-67. doi: 10.4085/1062-6050-48.1.12.

    PubMed 23672326
  • Nampo FK, Cavalheri V, Ramos Sde P, Camargo EA. Effect of low-level phototherapy on delayed onset muscle soreness: a systematic review and meta-analysis. Lasers Med Sci. 2016 Jan;31(1):165-77. doi: 10.1007/s10103-015-1832-4. Epub 2015 Nov 12.

    PubMed 26563953
  • Pinto HD, Vanin AA, Miranda EF, Tomazoni SS, Johnson DS, Albuquerque-Pontes GM, Aleixo IO Junior, Grandinetti VD, Casalechi HL, de Carvalho PT, Leal-Junior EC. Photobiomodulation Therapy Improves Performance and Accelerates Recovery of High-Level Rugby Players in Field Test: A Randomized, Crossover, Double-Blind, Placebo-Controlled Clinical Study. J Strength Cond Res. 2016 Dec;30(12):3329-3338. doi: 10.1519/JSC.0000000000001439.

    PubMed 27050245

Questions about this trial

What is this clinical trial studying?

A study testing LED before, LED interval and LED after in people with Phototherapy, run by Universidade Estadual de Londrina at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in creatine kinase (time frame: Before, immediately after and after 48 hours.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03728439, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.

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