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

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ClinicalTrials.gov Identifier: NCT03728439
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Universidade Estadual de Londrina

Tracking Information
First Submitted Date  ICMJE October 3, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date July 13, 2021
Actual Study Start Date  ICMJE February 1, 2019
Actual Primary Completion Date September 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2021)
  • 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.
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2021)
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
  • 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).
  • 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).
  • 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.
  • Functional performance in Side Hop Test [ Time Frame: Before, immediately after and after 48 hours. ]
    Measure the time (in seconds) for running the Side Hop Test.
  • 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.
  • Pain threshold using the pressure algometer. [ Time Frame: Before, immediately after and after 48 hours. ]
    Effect of LED therapy on delayed onset muscle soreness by calculating the pain threshold (kgf) using the pressure algometer.
  • Recovery and psychophysiological stress [ Time Frame: Before the performance testing protocol ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Light Emitting Diodes (LED) Therapy in Rugby Athletes
Official Title  ICMJE Analysis of Delayed Onset Muscle Soreness, Functional Performance, Inflammatory and Ergogenic Response of Light Emitting Diodes (LED) Therapy in Rugby Athletes
Brief 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 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Phototherapy
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: LED before
  • 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.
    Intervention: Device: LED interval
  • 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.
    Intervention: Device: LED after
  • No Intervention: Baseline
    On that day, participants will not receive any intervention.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2021)
21
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2018)
30
Actual Study Completion Date  ICMJE November 30, 2019
Actual Primary Completion Date September 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728439
Other Study ID Numbers  ICMJE Recovery in rugby athletes
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universidade Estadual de Londrina
Study Sponsor  ICMJE Universidade Estadual de Londrina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christiane Macedo State University of Londrina
PRS Account Universidade Estadual de Londrina
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP