- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02588768
Photobiomodulation Therapy in a Field Test With High-level Rugby Players
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
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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SP
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São Paulo, SP, Brazil, 01504001
- Universidade Nove de Julho
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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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).
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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:
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PLACEBO_COMPARATOR: Placebo PBMT
Placebo PBMT was applied using the same device that emitted the same sounds and light, but with no effective irradiation.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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The Average Time of sprints performed during entire test (ST mean).
This is the one of the variables from BST to evaluate performance.
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The test was performed for three weeks, once a week, on the same day and time of the week.
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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.
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The fastest (best) time (ST best) among the seven sprints performed at each test.
One of the variables from BST to evaluate performance.
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The test was performed for three weeks, once a week, on the same day and time of the week.
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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.
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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.
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The test was performed for three weeks, once a week, on the same day and time of the week.
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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.
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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.
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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.
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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.
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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).
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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.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19.
- Albuquerque-Pontes GM, Vieira RP, Tomazoni SS, Caires CO, Nemeth V, Vanin AA, Santos LA, Pinto HD, Marcos RL, Bjordal JM, de Carvalho Pde T, Leal-Junior EC. Effect of pre-irradiation with different doses, wavelengths, and application intervals of low-level laser therapy on cytochrome c oxidase activity in intact skeletal muscle of rats. Lasers Med Sci. 2015 Jan;30(1):59-66. doi: 10.1007/s10103-014-1616-2. Epub 2014 Jun 24.
- Wragg CB, Maxwell NS, Doust JH. Evaluation of the reliability and validity of a soccer-specific field test of repeated sprint ability. Eur J Appl Physiol. 2000 Sep;83(1):77-83. doi: 10.1007/s004210000246.
- Johnston RD, Gabbett TJ, Jenkins DG. Applied sport science of rugby league. Sports Med. 2014 Aug;44(8):1087-100. doi: 10.1007/s40279-014-0190-x.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CEP-665.347
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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