Muscular InjuryNCT03972007
Effect of Light-emitting Diode (LED) Photobiomodulation Therapy on Muscular Fatigue in University Handball Athletes
A study testing Fotobiomodulation in people with Muscular Injury, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Introduction: Low-intensity laser therapy (LBI) is a therapeutic modality with a large number of clinical studies in recent years, taking into account its effectiveness in tissue repair, pain control and, more recently, to increase performance. It is known that LED therapy has immediate effects. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscular Injury
- What is being tested?
- Fotobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 18 May 2019to 1 Oct 2021
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Handball practitioners;
- Absence of musculoskeletal injury in the last three months;
- Absence of anti-inflammatory and / or analgesic drugs 72 hours before the evaluations
Who cannot join
- Use of anabolic steroids;
- Presence of cardiovascular disease
- Use of alcohol and illicit drugs during the collection period
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade de São Paulo
Ribeirão Preto, São Paulo, 14049-900 Ribeirão Preto / SP
About this study
Introduction: Low-intensity laser therapy (LBI) is a therapeutic modality with a large number of clinical studies in recent years, taking into account its effectiveness in tissue repair, pain control and, more recently, to increase performance. It is known that LED therapy has immediate effects. Therefore, analyzing the TLED in the infrared spectrum for acute responses at different times along with fatigue resistance capabilities, heart rate variability and biochemical response to fatigue in handball athletes becomes necessary. Objective: To analyze the acute effects of LED phototherapy (940nm) on fatigue resistance and recovery after strenuous exercises of university athletes. Method: The study sample will consist of 32 and 36 male athletes, for biceps brachii and quadriceps femoris, respectively. The athletes will be randomly assigned into four groups: Immediate TLED (TLED-I), TLED 15Min (TLED-15), Immediate Sham (Sham-I) and Sham 15Min (Sham-15). The tests performed will involve bioimpedance evaluation, blood lactate, electromyographic analysis and evaluation of maximum voluntary contraction by means of the maximal repetition test (1RM). Thus, the TLED will be applied on the muscle group to be evaluated, unilaterally, the same tests being repeated in the sequence. 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 adopted.
Read the detailed description
It is a blinded randomized clinical trial. The athletes will undergo a previous evaluation (day 1) comprised by anamnesis and evaluation of the bioimpedance to analyze the body composition, will still carry out the evaluation of the load for a maximum repetition. Thus, 7 days after (day 2) the previous evaluation in the times immediately after and after 15 minutes of the LED application will be carried out new tests. These will involve assessment of blood lactate, heart rate variability and electromyography. In addition, during the execution of the fatigue protocol will be collected the number of repetitions of muscle contraction and its total execution time.
Due to the number of athletes that make up the university team (n = 19), cross-over will be necessary, where all athletes will initially be distributed to the 04 pre-defined groups in each subproject, and after the 7 days, they will be divided again.
- Conditions
- Muscular Injury
- Being tested
- Fotobiomodulation
- Keywords
- Physiotherapy, Muscle resistance, LED, Athletic performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FotobiomodulationDevice
A 16x28 cm LED blanket containing 160 LEDs will be used and will use a total energy per area of 60J, with a wavelength of 940nm, just before the muscle fatigue protocol and will be applied throughout the Biceps extension.
| Study group | Role | What they receive |
|---|---|---|
| Immediate LEDT Group | Experimental | The 940nm LED blanket will be positioned across the full length of the biceps brachii muscle in the dominant limb immediately before the muscle fatigue protocol. Receives: Device: Fotobiomodulation |
| LEDT Group 15Min | Experimental | The 940nm LED blanket will be positioned across the length of the biceps brachii muscle in the dominant limb 15 minutes before the muscle fatigue protocol. Receives: Device: Fotobiomodulation |
| Immediate Sham Group | Sham comparator | The 940nm LED blanket will be positioned throughout the biceps brachii muscle in the dominant limb, however, it will not be ligated, with no light emission, immediately prior to the muscle fatigue protocol. Receives: Device: Fotobiomodulation |
| Sham Group 15Min | Sham comparator | The 940nm LED blanket will be positioned throughout the biceps brachii muscle in the dominant limb, however, it will not be ligated, with no light emission, 15 minutes before the protocol of muscle fatigue. Receives: Device: Fotobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in number of repetitions
The present study was designed to detect the difference in the number of repetitions between the groups groups, after the interventions.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start18 May 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Muscular InjuryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
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 Guirro, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972007
- Sponsor's protocol ID
- Photobiomodulation on Strength
- Status last verified
- Mar 2021
- First submitted
- 27 May 2019
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared in manuscript form
Publications
Leal Junior EC, Lopes-Martins RA, Rossi RP, De Marchi T, Baroni BM, de Godoi V, Marcos RL, Ramos L, Bjordal JM. Effect of cluster multi-diode light emitting diode therapy (LEDT) on exercise-induced skeletal muscle fatigue and skeletal muscle recovery in humans. Lasers Surg Med. 2009 Oct;41(8):572-7. doi: 10.1002/lsm.20810.
PubMed 19731300Ferraresi C, Dos Santos RV, Marques G, Zangrande M, Leonaldo R, Hamblin MR, Bagnato VS, Parizotto NA. Light-emitting diode therapy (LEDT) before matches prevents increase in creatine kinase with a light dose response in volleyball players. Lasers Med Sci. 2015 May;30(4):1281-7. doi: 10.1007/s10103-015-1728-3. Epub 2015 Feb 27.
PubMed 25722067de Almeida P, Lopes-Martins RA, De Marchi T, Tomazoni SS, Albertini R, Correa JC, Rossi RP, Machado GP, da Silva DP, Bjordal JM, Leal Junior EC. Red (660 nm) and infrared (830 nm) low-level laser therapy in skeletal muscle fatigue in humans: what is better? Lasers Med Sci. 2012 Mar;27(2):453-8. doi: 10.1007/s10103-011-0957-3. Epub 2011 Jul 22.
PubMed 21814736
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Light-emitting Diode (LED) Photobiomodulation Therapy on Muscular Fatigue in University Handball Athletes
- ClinicalTrials.gov ID
- NCT03972007
- Acronym / sponsor ID
- Photobiomodulation on Strength
- Conditions
- Muscular Injury
- Keywords
- Physiotherapy, Muscle resistance, LED, Athletic performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 18 May 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 3 Jun 2019 (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.
Introduction: Low-intensity laser therapy (LBI) is a therapeutic modality with a large number of clinical studies in recent years, taking into account its effectiveness in tissue repair, pain control and, more recently, to increase performance. It is known that LED therapy has immediate effects. Therefore, analyzing the TLED in the infrared spectrum for acute responses at different times along with fatigue resistance capabilities, heart rate variability and biochemical response to fatigue in handball athletes becomes necessary. Objective: To analyze the acute effects of LED phototherapy (940nm) on fatigue resistance and recovery after strenuous exercises of university athletes. Method: The study sample will consist of 32 and 36 male athletes, for biceps brachii and quadriceps femoris, respectively. The athletes will be randomly assigned into four groups: Immediate TLED (TLED-I), TLED 15Min (TLED-15), Immediate Sham (Sham-I) and Sham 15Min (Sham-15). The tests performed will involve bioimpedance evaluation, blood lactate, electromyographic analysis and evaluation of maximum voluntary contraction by means of the maximal repetition test (1RM). Thus, the TLED will be applied on the muscle group to be evaluated, unilaterally, the same tests being repeated in the sequence. 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 adopted.
Detailed description
It is a blinded randomized clinical trial. The athletes will undergo a previous evaluation (day 1) comprised by anamnesis and evaluation of the bioimpedance to analyze the body composition, will still carry out the evaluation of the load for a maximum repetition. Thus, 7 days after (day 2) the previous evaluation in the times immediately after and after 15 minutes of the LED application will be carried out new tests. These will involve assessment of blood lactate, heart rate variability and electromyography. In addition, during the execution of the fatigue protocol will be collected the number of repetitions of muscle contraction and its total execution time.
Due to the number of athletes that make up the university team (n = 19), cross-over will be necessary, where all athletes will initially be distributed to the 04 pre-defined groups in each subproject, and after the 7 days, they will be divided again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Immediate LEDT Group | Experimental | Device: FotobiomodulationThe 940nm LED blanket will be positioned across the full length of the biceps brachii muscle in the dominant limb immediately before the muscle fatigue protocol. |
| LEDT Group 15Min | Experimental | Device: FotobiomodulationThe 940nm LED blanket will be positioned across the length of the biceps brachii muscle in the dominant limb 15 minutes before the muscle fatigue protocol. |
| Immediate Sham Group | Sham comparator | Device: FotobiomodulationThe 940nm LED blanket will be positioned throughout the biceps brachii muscle in the dominant limb, however, it will not be ligated, with no light emission, immediately prior to the muscle fatigue protocol. |
| Sham Group 15Min | Sham comparator | Device: FotobiomodulationThe 940nm LED blanket will be positioned throughout the biceps brachii muscle in the dominant limb, however, it will not be ligated, with no light emission, 15 minutes before the protocol of muscle fatigue. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Handball practitioners;
- Absence of musculoskeletal injury in the last three months;
- Absence of anti-inflammatory and / or analgesic drugs 72 hours before the evaluations
Key exclusion criteria (3 listed)
- Use of anabolic steroids;
- Presence of cardiovascular disease
- Use of alcohol and illicit drugs during the collection period
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 |
|---|---|---|
| FotobiomodulationA 16x28 cm LED blanket containing 160 LEDs will be used and will use a total energy per area of 60J, with a wavelength of 940nm, just before the muscle fatigue protocol and will be applied throughout the Biceps extension. | Device | Immediate LEDT Group, Immediate Sham Group, LEDT Group 15Min, Sham Group 15Min |
Primary outcome
Difference in number of repetitions
Time frame: 2 years
The present study was designed to detect the difference in the number of repetitions between the groups groups, after the interventions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Results publication: PubMed 19731300Leal Junior EC, Lopes-Martins RA, Rossi RP, De Marchi T, Baroni BM, de Godoi V, Marcos RL, Ramos L, Bjordal JM. Effect of cluster multi-diode light emitting diode therapy (LEDT) on exercise-induced skeletal muscle fatigue and skeletal muscle recovery in humans. Lasers Surg Med. 2009 Oct;41(8):572-7. doi: 10.1002/lsm.20810.
- Results publication: PubMed 25722067Ferraresi C, Dos Santos RV, Marques G, Zangrande M, Leonaldo R, Hamblin MR, Bagnato VS, Parizotto NA. Light-emitting diode therapy (LEDT) before matches prevents increase in creatine kinase with a light dose response in volleyball players. Lasers Med Sci. 2015 May;30(4):1281-7. doi: 10.1007/s10103-015-1728-3. Epub 2015 Feb 27.
- Results publication: PubMed 21814736de Almeida P, Lopes-Martins RA, De Marchi T, Tomazoni SS, Albertini R, Correa JC, Rossi RP, Machado GP, da Silva DP, Bjordal JM, Leal Junior EC. Red (660 nm) and infrared (830 nm) low-level laser therapy in skeletal muscle fatigue in humans: what is better? Lasers Med Sci. 2012 Mar;27(2):453-8. doi: 10.1007/s10103-011-0957-3. Epub 2011 Jul 22.
- Individual participant dataSharing planned: No. The data will be shared in manuscript form
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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 Guirro 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 Fotobiomodulation in people with Muscular Injury, 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 3 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: status not confirmed, as of the sponsor's last update on 22 Mar 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?
Results are not available in the source record.
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?
Difference in number of repetitions (time frame: 2 years). 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 NCT03972007, which also lists 3 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 22 Mar 2021.