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

Performance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588768
• Other study ID #: CEP-665.347
• Status: Completed
• Phase: N/A
• First received: October 24, 2015
• Last updated: February 2, 2016
• Start date: February 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• High-level Rugby Athletes
• Performance
• Recovery

Intervention

Device:
• Photobiomodulation therapy (Phototherapy)
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).

Locations

Country	Name	City	State
Brazil	Universidade Nove de Julho	São Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
University of Nove de Julho	Multi Radiance Medical, São José Rugby Club

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Albuquerque-Pontes GM, Vieira Rde P, 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-l — View Citation

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 — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bangsbo Sprint Test (BST) - Average Time (sec)	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.	Yes
Primary	Bangsbo Sprint Test (BST) - Best Time (sec)	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.	Yes
Primary	Bangsbo Sprint Test (BST) - Fatigue Index (%)	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.	Yes
Secondary	Questionnaire of fatigue	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.	Yes
Secondary	Blood Lactate analysis	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.	Yes