High-level Rugby AthletesNCT02588768
Photobiomodulation Therapy in a Field Test With High-level Rugby Players
A study testing Photobiomodulation therapy (Phototherapy) in people with High-level Rugby Athletes and Performance, run by University of Nove de Julho at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- High-level Rugby Athletes, Performance, Recovery
- What is being tested?
- Photobiomodulation therapy (Phototherapy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- high-level athletes from São José Rugby Club (Brazil)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- High-level Rugby Athletes, Performance, Recovery
- Being tested
- Photobiomodulation therapy (Phototherapy)
- Keywords
- Low-level laser therapy, Light emitting diodes, Rugby, Field test, Photobiomodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation therapy (Phototherapy)Device
Also called Photobiomodulation therapy (PBMT)
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: Photobiomodulation therapy (Phototherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for High-level Rugby AthletesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Multi Radiance Medical, São José Rugby Club
- Responsible party
- Principal investigator, Adriane Aver Vanin, University of Nove de Julho
- Investigators
- Ernesto Cesar P Leal-Junior, PhD, PT, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588768
- Sponsor's protocol ID
- CEP-665.347
- Status last verified
- Feb 2016
- First submitted
- 24 Oct 2015
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: all data is properly stored in electronic devices and available for possible doubts regarding to methodological procedures or results.
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.
PubMed 24942380Albuquerque-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.
PubMed 24957189Wragg 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.
PubMed 11072777Johnston 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.
PubMed 24748460
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phototherapy (With a Combination of Super-pulsed Laser and LEDs) in a Field Test With High-level Rugby Players
- ClinicalTrials.gov ID
- NCT02588768
- Acronym / sponsor ID
- CEP-665.347
- Conditions
- High-level Rugby Athletes, Performance, Recovery
- Keywords
- Low-level laser therapy, Light emitting diodes, Rugby, Field test, Photobiomodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Multi Radiance Medical, São José Rugby Club
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PBMT | Active comparator | Device: Photobiomodulation therapy (Phototherapy)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). |
| Placebo PBMT | Placebo comparator | Device: Photobiomodulation therapy (Phototherapy)Placebo PBMT was applied using the same device that emitted the same sounds and light, but with no effective irradiation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- high-level athletes from São José Rugby Club (Brazil)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation therapy (Phototherapy)Also: Photobiomodulation therapy (PBMT)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). | Device | Active PBMT, Placebo PBMT |
Primary outcome
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.
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.
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Results publication: PubMed 24942380Antonialli 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.
- Results publication: PubMed 24957189Albuquerque-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.
- Results publication: PubMed 11072777Wragg 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.
- Results publication: PubMed 24748460Johnston 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.
- Individual participant dataSharing planned: Yes. all data is properly stored in electronic devices and available for possible doubts regarding to methodological procedures or results.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernesto Cesar P Leal-Junior, PhD, PT principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation therapy (Phototherapy) in people with High-level Rugby Athletes and Performance, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02588768, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.