NCT03728439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

October 3, 2018

Last Update Submit

July 7, 2021

Conditions

Keywords

RecoveryRugbyPhototherapy

Outcome Measures

Primary Outcomes (3)

  • Changes in creatine kinase

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

    Before, immediately after and after 48 hours.

  • Bangsbo sprint test

    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

    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 Outcomes (4)

  • Functional performance in the Star Excursion Balance Test

    Before, immediately after and after 48 hours.

  • Functional performance in Single Hop Test and Triple Hop Test

    Before, immediately after and after 48 hours.

  • Recovery and psychophysiological stress

    48 hours after performance tests

  • Changes in blood lactate

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

Study Arms (4)

Before

EXPERIMENTAL

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

Interval

EXPERIMENTAL

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

After

EXPERIMENTAL

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

Baseline

NO INTERVENTION

On that day, participants will not receive any intervention.

Interventions

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.

Before

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.

Interval
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.

After

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Injuries that make it impossible to perform the tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of the State University of Londrina

Londrina, Paraná, 86038-350, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 25722067BACKGROUND
  • 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.

    PMID: 24249354BACKGROUND
  • 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.

    PMID: 23672326BACKGROUND
  • 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.

    PMID: 26563953BACKGROUND
  • 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.

    PMID: 27050245BACKGROUND

Study Officials

  • Christiane Macedo

    State University of Londrina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2018

First Posted

November 2, 2018

Study Start

February 1, 2019

Primary Completion

September 10, 2019

Study Completion

November 30, 2019

Last Updated

July 13, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations