Photobiomodulation Therapy in a Field Test With High-level Rugby Players

February 2, 2016 updated by: Adriane Aver Vanin, University of Nove de Julho

Phototherapy (With a Combination of Super-pulsed Laser and LEDs) in a Field Test With High-level Rugby Players

Background/Aim: While growing evidence supports the use of photobiomodulation therapy (PBMT) for performance and recovery enhancement, there have only been laboratory-controlled studies. Therefore, the aim of this study was to analyze the effects of PBMT in performance and recovery of high-level rugby players during an anaerobic field test.

Methods: It is a randomized, crossover, double-blinded, placebo-controlled trial. Twelve male high-level rugby athletes were recruited in this study. No intervention was performed before the Bangsbo Sprint Test (BST) at familiarization phase (week 1). At weeks 2 and 3, pre-exercise PBMT or placebo were randomly applied to each athlete. PBMT/placebo irradiation was performed at 17 sites of each lower limb, employing a cluster with 12 diodes (4 laser diodes of 905nm, 4 LED diodes of 875nm, and 4 LED diodes of 640nm, 30J per site - manufactured by Multi Radiance Medical™). Average time of sprints, best time of sprints, and fatigue index were obtained from BST. Blood lactate levels were assessed at baseline, and at 3, 10, 30 and 60 minutes after BST. Athletes' perceived fatigue was also assessed through a questionnaire.

Study Overview

Detailed Description

All exercise tests were conducted in an enclosed soccer/rugby field. The three test phases, administered one week apart, were performed on the same day of the week (Tuesday) and time (1-5pm). The average temperature inside the building during the trials ranged from 26°C to 28°C. At first stage (exercise test 1) all athletes performed the Bangsbo Sprint Test (BST) to familiarization with the procedure. No interventions or comparators were applied before this test. However, at the second and third stages (exercise tests 2 and 3, respectively) either a placebo or active PBMT was applied according to randomization. Blood samples were collected from the athlete's fingertips prior to stretching and warming-up (baseline), and at 3, 10, 30 and 60 minutes after BST at each of the three study stages/phase (exercise tests). After blood sample collection (to establish baseline), a warm-up comprised of low-intensity activities such as dynamic stretches and low-intensity short running were performed by each athlete. Following the warm-up and cool down period, either the active or placebo comparator was applied to the athlete according to the randomization procedure for the second test. For the third test, the other comparator was utilized to complete the cross over design. A quick perception of fatigue survey was administered following each test.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • 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

    • SP
      • São Paulo, SP, Brazil, 01504001
        • Universidade Nove de Julho

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

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • high-level athletes from São José Rugby Club (Brazil)

Exclusion Criteria:

  • Athlete would be excluded if the participant presented any skeletal muscle injury
  • if athlete took any nutritional supplement or pharmacological agent
  • if the athlete presented signs and symptoms of any disease (i.e., neurological, inflammatory, pulmonary, metabolic, oncologic), and
  • if the athlete had history of cardiac arrest that could limit performance of high-intensity exercises

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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Active PBMT
Active PBMT was applied employing MR4 Laser Therapy Systems outfitted with LaserShower 50 4D emitters (both manufactured by Multi Radiance Medical, Solon - OH, USA). The cluster style emitter contains 12 diodes comprising of four super-pulsed laser diodes (905 nm, 0.3125 mW average power, and 12.5 W peak power for each diode), four red LED diodes (640 nm, 15 mW average power for each diode), and four infrared LEDs diodes (875 nm, 17.5 mW average power for each diode).
PBMT was applied employing MR4 Laser Therapy Systems manufactured by Multi Radiance Medical, Solon - OH, USA. The cluster emitter contains 12 diodes with four super-pulsed laser diodes (905 nm, 0.3125 mW average power, and 12.5 W peak power for each diode), four red LED diodes (640 nm, 15 mW average power for each diode), and four infrared LEDs diodes (875 nm, 17.5 mW average power for each diode). It was applied in direct contact with the skin to 9 sites on extensor muscles of the knee, 6 sites on knee flexors of the knee, and 2 sites on the calf of both lower limbs. To ensure blinding, the device emitted the same sounds and regardless of the programmed mode (active or placebo).
Other Names:
  • Photobiomodulation therapy (PBMT)
PLACEBO_COMPARATOR: Placebo PBMT
Placebo PBMT was applied using the same device that emitted the same sounds and light, but with no effective irradiation.
PBMT was applied employing MR4 Laser Therapy Systems manufactured by Multi Radiance Medical, Solon - OH, USA. The cluster emitter contains 12 diodes with four super-pulsed laser diodes (905 nm, 0.3125 mW average power, and 12.5 W peak power for each diode), four red LED diodes (640 nm, 15 mW average power for each diode), and four infrared LEDs diodes (875 nm, 17.5 mW average power for each diode). It was applied in direct contact with the skin to 9 sites on extensor muscles of the knee, 6 sites on knee flexors of the knee, and 2 sites on the calf of both lower limbs. To ensure blinding, the device emitted the same sounds and regardless of the programmed mode (active or placebo).
Other Names:
  • Photobiomodulation therapy (PBMT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bangsbo Sprint Test (BST) - Average Time (sec)
Time Frame: The test was performed for three weeks, once a week, on the same day and time of the week.
The Average Time of sprints performed during entire test (ST mean). This is the one of the variables from BST to evaluate performance.
The test was performed for three weeks, once a week, on the same day and time of the week.
Bangsbo Sprint Test (BST) - Best Time (sec)
Time Frame: The test was performed for three weeks, once a week, on the same day and time of the week.
The fastest (best) time (ST best) among the seven sprints performed at each test. One of the variables from BST to evaluate performance.
The test was performed for three weeks, once a week, on the same day and time of the week.
Bangsbo Sprint Test (BST) - Fatigue Index (%)
Time Frame: The test was performed for three weeks, once a week, on the same day and time of the week.
Fatigue index was calculated by the following equation: FI(%)= (STmean / STbest x 100) ˗ 100 to measure the percentage of decrease in performance between all sprints. One of the variables from BST to evaluate performance.
The test was performed for three weeks, once a week, on the same day and time of the week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire of fatigue
Time Frame: This questionnaire was answered for the participants in the last day of the tests, so, at the end of the third week of the tests.
A quick perception of fatigue survey. The questionnaire consisted of eight questions pertaining to perception of training, sleep, leg pain, concentration, effectiveness, anxiety, irritability and stress. Each question was evaluated according to a score scale where 1-2 points corresponds to "not at all", 3-4 points to "normal", and 5-7 to "very much". The scores was calculated according to the relative importance of each question and a lower score indicates better general well-being perception, and a higher score demonstrates greater fatigue perception.
This questionnaire was answered for the participants in the last day of the tests, so, at the end of the third week of the tests.
Blood Lactate analysis
Time Frame: Blood sample was collected in the three phases of the study (three weeks, once a week) at 3, 10, 30 and 60 minutes after BST.
Blood samples were collected from the athlete's fingertips prior to stretching and warming-up (baseline), and at 3, 10, 30 and 60 minutes after BST at each of the three study stages/phase (exercise tests).
Blood sample was collected in the three phases of the study (three weeks, once a week) at 3, 10, 30 and 60 minutes after BST.

Collaborators and Investigators

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

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.

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

February 1, 2015

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

October 24, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (ESTIMATE)

October 28, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

February 4, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all data is properly stored in electronic devices and available for possible doubts regarding to methodological procedures or results.

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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