AthletesNCT03225976
Effect of Light-Emitting Diode on the Strenght and Resistence Capacities of Cycling Athletes
A study testing Light-Emitting Diode Device in people with Athletes, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Phototherapy is a therapeutic resource of increasing use in the last decade. The photobiomodulatory effects are commonly produced by means of low intensity lasers or LED emitting diodes, and can be used at different wavelengths. These light sources are divergent as to coherence, but produce equivalent tissue effects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athletes
- What is being tested?
- Light-Emitting Diode Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Jan 2018to 12 Mar 2019
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cycling practitioners
- Age between 18 and 45 years;
- Male
- VO2MÁX > 40 ml.kg-1.min-1;
- Absence of musculoskeletal injury in the last six months
Who cannot join
- Carriers of Cardiorespiratory Diseases;
- Users of anti-inflammatory and analgesic drugs
- Users of Alcohol and illicit drugs
Trial locations and contacts
1 site in 1 country.
About this study
Phototherapy is a therapeutic resource of increasing use in the last decade. The photobiomodulatory effects are commonly produced by means of low intensity lasers or LED emitting diodes, and can be used at different wavelengths. These light sources are divergent as to coherence, but produce equivalent tissue effects. The application of laser or LED light is able to induce biochemical changes in tissues, allowing for inhibitory or stimulating effects. These responses are associated to a cascade of cellular reactions, which favor the absorption of enzymes by cytochrome c oxidase, generating physiological responses that lead to decreased production of reactive oxygen species and increased synthesis of adenosine triphosphate (ATP). The application of this therapeutic resource brings ergogenic and protective benefits in muscular performance. The use of LED as a light source is promising because of its low cost, but there are no enough studies that support this use in athletes, with a focus on performance improvement. In addition to the deficiency of the sample, there is also no consensus regarding the use of different wavelengths for LED in the literature, thus opening gaps for the best protocol for the application of this technique. Therefore, a study that evaluates the use of LED in athletes, with different wavelengths, to improve performance is necessary. Hypothesis: It is hypothesized that the LED application is capable of improving athletes performance in terms of increased fatigue resistance, increased strength and power, increased muscle recruitment, and optimized oxygen demand. It is also expected that the results generated in this study can contribute to and increase the resources used by physiotherapists within the clinical-sports field, contributing to the post-training recovery, as well as the more effective physical performance in competitive activities.
Read the detailed description
Background: Phototherapy is a therapeutic resource of increasing use in the last decade. The photobiomodulatory effects are produced by sources of low-level lasers or light- emitting diode (LEDT), and their tissue effects are equivalent. The application of this therapeutic resource brings ergogenic and protective benefits in muscular performance. The use of LED as a light source is promising because of its low cost, but there are no enough studies that support this use in athletes, with a focus on performance improvement. In addition to the deficiency of the sample, there is also no consensus regarding the use of different wavelengths for LED in the literature, thus opening gaps for the best protocol for the application of this technique. Therefore, a study that evaluates the use of LED in athletes, with different wavelengths, to improve performance is necessary. Objective: To analyze the acute effects of the application of LED phototherapy on the strength and fatigue strength abilities of cycling athletes. Method: The study sample will be composed of 48 male cyclist athletes randomly allocated into three groups: Infrared LED Group (G-I), Red LED Group (G-V), Infrared plus Red Group (G-IV) and Sham Group (G-S). The athletes will be submitted to a battery of tests, for performance evaluation which consist of anaerobic and aerobic power and threshold, bioimpedance, infrared thermography, creatine kinase (CK) and blood lactate analysis, measurement of local muscle blood flow, Gas analysis, besides the isokinetic, electromyographic and biomechanical evaluations. After 24 hours of the tests, the LEDT (180 J) will be applied three times in three differents days to the quadriceps femoris muscle bilaterally. The same tests will be performed 24 hours after the application of LEDT. In the 1st and 4th week, post intervention, only the isokinetic and electromyographic evaluations will be performed. For analysis of the data, normality test will be used to verify the distribution and adequate statistical tests for the appropriate intra and intergroup comparisons, being considered two factors in the comparisons, time and group. A significance level of 5% will be adopte
- Conditions
- Athletes
- Being tested
- Light-Emitting Diode Device, Sham Light-Emitting Diode Device
- Keywords
- Phototherapy, Athletic Performance, Muscle Strength, Fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light-Emitting Diode DeviceDevice
The therapy will be applied on the second, third and fourth day of collection using a 25x40 cm2 LED blanket, with an equidistant distribution, with total energy per area of 180 J bilaterally on the quadriceps femoris muscle.
All LEDs will be calibrated prior to the start of applications in the Laboratory of Photobiophysics of the Faculty of Sciences and Letters of Ribeirão Preto, University of São Paulo, in which the wavelengths will be checked, the angle of radiation, power and power density.
Sham Light-Emitting Diode DeviceDevice
The Sham Light-Emitting Diode Device will be applied on the second, third and fourth day of collection using a 25x40 cm2 LED blanket, with an equidistant distribution, with total energy per area of 0 J bilaterally on the quadriceps femoris muscle. At the time of application the device will not be activated
| Study group | Role | What they receive |
|---|---|---|
| Infrared LED group (G-I) | Experimental | The Light-Emitting Diode Device with wavelength of 904nm will be applied throughout the quadriceps femoralis extension bilaterally. Receives: Device: Light-Emitting Diode Device |
| Red LED group (G-V) | Experimental | The Light-Emitting Diode Device with a wavelength of 620nm will be applied throughout the quadriceps femoralis extension bilaterally. Receives: Device: Light-Emitting Diode Device |
| Sham Group (G-S) | Sham comparator | The Sham Light-Emitting Diode Device will be positioned throughout the quadriceps femoral muscle extension, however, there will be no light emission. Receives: Device: Sham Light-Emitting Diode Device |
| Infrared plus Red LED group (G-IV) | Experimental | The Light-Emitting Diode Device with a wavelength of 620nm plus 904nm will be applied throughout the quadriceps femoralis extension bilaterally. Receives: Device: Light-Emitting Diode Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strenght Capacities
N/m
Measured: Twenty minutes
Secondary outcomes (8)
Resistence Capacities
Minutes
Measured: Twenty Minutes
Muscle recruitment
Hertz
Measured: Twenty Minutes
Gas analysis
ml.kg-1.min-1
Measured: Twenty Minutes
Lactate analysis
mmol/L
Measured: Twenty Minutes
Creatine Kinase Analysis
IU/L
Measured: Five Minutes
Thermography
Celsius Degree
Measured: Fifteen Minutes
Local blood flow
mL/s
Measured: Twenty Minutes
Power
Watts
Measured: Twenty Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start25 Jan 2018
- Primary completion25 Dec 2018
- Study completion12 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AthletesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Athletes will be randomized allocated the following groups: * Infrared LED group (G-I; n = 12) * Red LED group (G-V; n = 12) * Infrared plus Red LED group (G-IV; n = 12) * Sham Group (G-S; n = 12)
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
- Investigators
- Rinaldo RJ Roberto de Jesus Guirro, Dr, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225976
- Sponsor's protocol ID
- U1111-1143-7629
- Status last verified
- Apr 2021
- First submitted
- 19 Jul 2017
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferraresi C, Huang YY, Hamblin MR. Photobiomodulation in human muscle tissue: an advantage in sports performance? J Biophotonics. 2016 Dec;9(11-12):1273-1299. doi: 10.1002/jbio.201600176. Epub 2016 Nov 22.
PubMed 27874264de Carvalho G, Gobbi A, Gobbi RB, Alfredo DMN, do Carmo Furquim TH, Barbosa RI, Papoti M, de Jesus Guirro RR. Photobiomodulation by light emitting diode applied sequentially does not alter performance in cycling athletes. Lasers Med Sci. 2020 Oct;35(8):1769-1779. doi: 10.1007/s10103-020-02973-9. Epub 2020 Feb 20.
PubMed 32078062
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Light-Emitting Diode on the Strenght and Resistence Capacities of Cycling Athletes
- ClinicalTrials.gov ID
- NCT03225976
- Acronym / sponsor ID
- U1111-1143-7629
- Conditions
- Athletes
- Keywords
- Phototherapy, Athletic Performance, Muscle Strength, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 25 Dec 2018 (actual)
- Study completion
- 12 Mar 2019 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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.
Phototherapy is a therapeutic resource of increasing use in the last decade. The photobiomodulatory effects are commonly produced by means of low intensity lasers or LED emitting diodes, and can be used at different wavelengths. These light sources are divergent as to coherence, but produce equivalent tissue effects. The application of laser or LED light is able to induce biochemical changes in tissues, allowing for inhibitory or stimulating effects. These responses are associated to a cascade of cellular reactions, which favor the absorption of enzymes by cytochrome c oxidase, generating physiological responses that lead to decreased production of reactive oxygen species and increased synthesis of adenosine triphosphate (ATP). The application of this therapeutic resource brings ergogenic and protective benefits in muscular performance. The use of LED as a light source is promising because of its low cost, but there are no enough studies that support this use in athletes, with a focus on performance improvement. In addition to the deficiency of the sample, there is also no consensus regarding the use of different wavelengths for LED in the literature, thus opening gaps for the best protocol for the application of this technique. Therefore, a study that evaluates the use of LED in athletes, with different wavelengths, to improve performance is necessary. Hypothesis: It is hypothesized that the LED application is capable of improving athletes performance in terms of increased fatigue resistance, increased strength and power, increased muscle recruitment, and optimized oxygen demand. It is also expected that the results generated in this study can contribute to and increase the resources used by physiotherapists within the clinical-sports field, contributing to the post-training recovery, as well as the more effective physical performance in competitive activities.
Detailed description
Background: Phototherapy is a therapeutic resource of increasing use in the last decade. The photobiomodulatory effects are produced by sources of low-level lasers or light- emitting diode (LEDT), and their tissue effects are equivalent. The application of this therapeutic resource brings ergogenic and protective benefits in muscular performance. The use of LED as a light source is promising because of its low cost, but there are no enough studies that support this use in athletes, with a focus on performance improvement. In addition to the deficiency of the sample, there is also no consensus regarding the use of different wavelengths for LED in the literature, thus opening gaps for the best protocol for the application of this technique. Therefore, a study that evaluates the use of LED in athletes, with different wavelengths, to improve performance is necessary. Objective: To analyze the acute effects of the application of LED phototherapy on the strength and fatigue strength abilities of cycling athletes. Method: The study sample will be composed of 48 male cyclist athletes randomly allocated into three groups: Infrared LED Group (G-I), Red LED Group (G-V), Infrared plus Red Group (G-IV) and Sham Group (G-S). The athletes will be submitted to a battery of tests, for performance evaluation which consist of anaerobic and aerobic power and threshold, bioimpedance, infrared thermography, creatine kinase (CK) and blood lactate analysis, measurement of local muscle blood flow, Gas analysis, besides the isokinetic, electromyographic and biomechanical evaluations. After 24 hours of the tests, the LEDT (180 J) will be applied three times in three differents days to the quadriceps femoris muscle bilaterally. The same tests will be performed 24 hours after the application of LEDT. In the 1st and 4th week, post intervention, only the isokinetic and electromyographic evaluations will be performed. For analysis of the data, normality test will be used to verify the distribution and adequate statistical tests for the appropriate intra and intergroup comparisons, being considered two factors in the comparisons, time and group. A significance level of 5% will be adopte
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Athletes will be randomized allocated the following groups: * Infrared LED group (G-I; n = 12) * Red LED group (G-V; n = 12) * Infrared plus Red LED group (G-IV; n = 12) * Sham Group (G-S; n = 12)
| Arm | Type | Receives |
|---|---|---|
| Infrared LED group (G-I) | Experimental | Device: Light-Emitting Diode DeviceThe Light-Emitting Diode Device with wavelength of 904nm will be applied throughout the quadriceps femoralis extension bilaterally. |
| Red LED group (G-V) | Experimental | Device: Light-Emitting Diode DeviceThe Light-Emitting Diode Device with a wavelength of 620nm will be applied throughout the quadriceps femoralis extension bilaterally. |
| Sham Group (G-S) | Sham comparator | Device: Sham Light-Emitting Diode DeviceThe Sham Light-Emitting Diode Device will be positioned throughout the quadriceps femoral muscle extension, however, there will be no light emission. |
| Infrared plus Red LED group (G-IV) | Experimental | Device: Light-Emitting Diode DeviceThe Light-Emitting Diode Device with a wavelength of 620nm plus 904nm will be applied throughout the quadriceps femoralis extension bilaterally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Cycling practitioners
- Age between 18 and 45 years;
- Male
- VO2MÁX > 40 ml.kg-1.min-1;
- Absence of musculoskeletal injury in the last six months
Key exclusion criteria (3 listed)
- Carriers of Cardiorespiratory Diseases;
- Users of anti-inflammatory and analgesic drugs
- Users of Alcohol and illicit drugs
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 |
|---|---|---|
| Light-Emitting Diode DeviceThe therapy will be applied on the second, third and fourth day of collection using a 25x40 cm2 LED blanket, with an equidistant distribution, with total energy per area of 180 J bilaterally on the quadriceps femoris muscle. All LEDs will be calibrated prior to the start of applications in the Laboratory of Photobiophysics of the Faculty of Sciences and Letters of Ribeirão Preto, University of São Paulo, in which the wavelengths will be checked, the angle of radiation, power and power density. | Device | Infrared LED group (G-I), Infrared plus Red LED group (G-IV), Red LED group (G-V) |
| Sham Light-Emitting Diode DeviceThe Sham Light-Emitting Diode Device will be applied on the second, third and fourth day of collection using a 25x40 cm2 LED blanket, with an equidistant distribution, with total energy per area of 0 J bilaterally on the quadriceps femoris muscle. At the time of application the device will not be activated | Device | Sham Group (G-S) |
Primary outcome
Strenght Capacities
Time frame: Twenty minutes
N/m
8 secondary outcomes
Resistence Capacities
Time frame: Twenty Minutes
Muscle recruitment
Time frame: Twenty Minutes
Gas analysis
Time frame: Twenty Minutes
Lactate analysis
Time frame: Twenty Minutes
Creatine Kinase Analysis
Time frame: Five Minutes
Thermography
Time frame: Fifteen Minutes
Local blood flow
Time frame: Twenty Minutes
Power
Time frame: Twenty Minutes
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 29 Apr 2021.
- Results publication: PubMed 27874264Ferraresi C, Huang YY, Hamblin MR. Photobiomodulation in human muscle tissue: an advantage in sports performance? J Biophotonics. 2016 Dec;9(11-12):1273-1299. doi: 10.1002/jbio.201600176. Epub 2016 Nov 22.
- Derived from this study: PubMed 32078062de Carvalho G, Gobbi A, Gobbi RB, Alfredo DMN, do Carmo Furquim TH, Barbosa RI, Papoti M, de Jesus Guirro RR. Photobiomodulation by light emitting diode applied sequentially does not alter performance in cycling athletes. Lasers Med Sci. 2020 Oct;35(8):1769-1779. doi: 10.1007/s10103-020-02973-9. Epub 2020 Feb 20.
- Page intended to research scientific articles published in journalsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Rinaldo RJ Roberto de Jesus Guirro, Dr study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light-Emitting Diode Device in people with Athletes, run by University of Sao Paulo 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 5 inclusion and 3 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 29 Apr 2021. 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?
Strenght Capacities (time frame: Twenty minutes). 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 NCT03225976, which also lists 2 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 29 Apr 2021.