NCT02588768

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

9 months

First QC Date

October 24, 2015

Last Update Submit

February 2, 2016

Conditions

Keywords

Low-level laser therapyLight emitting diodesRugbyField testPhotobiomodulation

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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.

Secondary Outcomes (2)

  • Questionnaire of fatigue

    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

    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.

Study Arms (2)

Active PBMT

ACTIVE COMPARATOR

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).

Device: Photobiomodulation therapy (Phototherapy)

Placebo PBMT

PLACEBO COMPARATOR

Placebo PBMT was applied using the same device that emitted the same sounds and light, but with no effective irradiation.

Device: Photobiomodulation therapy (Phototherapy)

Interventions

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).

Also known as: Photobiomodulation therapy (PBMT)
Active PBMTPlacebo PBMT

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Nove de Julho

São Paulo, São Paulo, 01504001, Brazil

Location

Related Publications (4)

  • 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.

MeSH Terms

Interventions

Low-Level Light TherapyPhototherapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeutics

Study Officials

  • Ernesto Cesar P Leal-Junior, PhD, PT

    University of Nove de Julho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

October 24, 2015

First Posted

October 28, 2015

Study Start

February 1, 2015

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

February 4, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

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

Locations