AthleteNCT01770977
Effects of Phototherapy by Light-emitting Diode Therapy (LEDT) on Clinical, Biochemical and Biomechanical of Muscle Performance in Athletes
A study testing Light-emitting diode therapy in people with Athlete, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
Light-emitting diode Therapy (LEDT) has been used to improve human muscle performance in experimental models and human researches. Now, the investigators used LEDT to increase muscle performance of professional athletes with high performance. Read more about this study
- Who is it for?
- Ages 14 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athlete
- What is being tested?
- Light-emitting diode therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- May 2012to Sep 2012
- 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 14 to 28 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- professional athletes aged between 14 and 16 years;
- professional athletes aged between 18 and 28 years
Who cannot join
- previous injury to the femoral quadriceps or hamstring muscles,
- osseous or articular disorder in the lower limbs,
- cardiovascular system disorders,
- systemic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Light-emitting diode Therapy (LEDT) has been used to improve human muscle performance in experimental models and human researches. Now, the investigators used LEDT to increase muscle performance of professional athletes with high performance.
Read the detailed description
The study assessed muscle performance by vertical jump (height of jump and muscle power); creatine kinase; lactate; metabolism by resonance nuclear magnetic in urine; oxygen uptake (VO2) and its onset kinetic response.
- Conditions
- Athlete
- Being tested
- Light-emitting diode therapy, Placebo light-emitting diode therapy
- Keywords
- Light-emitting diode therapy, Muscle performance, Aerobic performance, Lactate, Creatine kinase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light-emitting diode therapyDevice
Also called LED, LED therapy
Placebo light-emitting diode therapyDevice
Also called Other Names:, LED, Light-emitting diode therapy, LED therapy
| Study group | Role | What they receive |
|---|---|---|
| Effective Light-emitting diode therapy | Active comparator | Effects of light-emitting diode therapy on clinical, biochemical and biomechanical of muscle performance in athletes Receives: Device: Light-emitting diode therapy |
| Placebo light-emitting diode therapy | Placebo comparator | Effect of placebo light-emitting diode therapy on clinical, biochemical and biomechanical of muscle performance in athletes Receives: Device: Placebo light-emitting diode therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional performance
Muscle performance in vertical jump and running
Measured: 6 weeks
Secondary outcomes (1)
Biochemical analysis
Blood lactate and creatine kinase assessments
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startMay 2012
- Primary completionJul 2012
- Study completionSep 2012
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 AthleteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Centro de Pequisas de Ótica e Fotônica
- Responsible party
- Principal investigator, Cleber Ferraresi, Universidade Federal de Sao Carlos
- Investigators
- Cleber Ferraresi, MSc, Principal investigator, Universidade Federal de Sao CarlosNivaldo A Parizotto, PhD, Study director, Universidade Federal de Sao CarlosVanderlei S Bagnato, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770977
- Sponsor's protocol ID
- CAAE: 0327.0.135.000-11
- Status last verified
- Sep 2012
- First submitted
- 15 Sep 2012
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ferraresi C, de Brito Oliveira T, de Oliveira Zafalon L, de Menezes Reiff RB, Baldissera V, de Andrade Perez SE, Matheucci Junior E, Parizotto NA. Effects of low level laser therapy (808 nm) on physical strength training in humans. Lasers Med Sci. 2011 May;26(3):349-58. doi: 10.1007/s10103-010-0855-0. Epub 2010 Nov 18.
PubMed 21086010Vieira WH, Ferraresi C, Perez SE, Baldissera V, Parizotto NA. Effects of low-level laser therapy (808 nm) on isokinetic muscle performance of young women submitted to endurance training: a randomized controlled clinical trial. Lasers Med Sci. 2012 Mar;27(2):497-504. doi: 10.1007/s10103-011-0984-0. Epub 2011 Aug 26.
PubMed 21870127Ferraresi C, Beltrame T, Fabrizzi F, do Nascimento ES, Karsten M, Francisco Cde O, Borghi-Silva A, Catai AM, Cardoso DR, Ferreira AG, Hamblin MR, Bagnato VS, Parizotto NA. Muscular pre-conditioning using light-emitting diode therapy (LEDT) for high-intensity exercise: a randomized double-blind placebo-controlled trial with a single elite runner. Physiother Theory Pract. 2015 Jul;31(5):354-61. doi: 10.3109/09593985.2014.1003118. Epub 2015 Jan 14.
PubMed 25585514
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Phototherapy by Light-emitting Diode Therapy (LEDT) on Clinical, Biochemical and Biomechanical of Muscle Performance in Athletes
- ClinicalTrials.gov ID
- NCT01770977
- Acronym / sponsor ID
- CAAE: 0327.0.135.000-11
- Conditions
- Athlete
- Keywords
- Light-emitting diode therapy, Muscle performance, Aerobic performance, Lactate, Creatine kinase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Centro de Pequisas de Ótica e Fotônica
- Study start
- May 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 18 Jan 2013 (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.
Light-emitting diode Therapy (LEDT) has been used to improve human muscle performance in experimental models and human researches. Now, the investigators used LEDT to increase muscle performance of professional athletes with high performance.
Detailed description
The study assessed muscle performance by vertical jump (height of jump and muscle power); creatine kinase; lactate; metabolism by resonance nuclear magnetic in urine; oxygen uptake (VO2) and its onset kinetic response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effective Light-emitting diode therapy | Active comparator | Device: Light-emitting diode therapyEffects of light-emitting diode therapy on clinical, biochemical and biomechanical of muscle performance in athletes |
| Placebo light-emitting diode therapy | Placebo comparator | Device: Placebo light-emitting diode therapyEffect of placebo light-emitting diode therapy on clinical, biochemical and biomechanical of muscle performance in athletes |
Who may qualify
- Ages
- 14 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- professional athletes aged between 14 and 16 years;
- professional athletes aged between 18 and 28 years
Key exclusion criteria (4 listed)
- previous injury to the femoral quadriceps or hamstring muscles,
- osseous or articular disorder in the lower limbs,
- cardiovascular system disorders,
- systemic disease.
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 therapyAlso: LED, LED therapy | Device | Effective Light-emitting diode therapy |
| Placebo light-emitting diode therapyAlso: Other Names:, LED, Light-emitting diode therapy, LED therapy | Device | Placebo light-emitting diode therapy |
Primary outcome
Functional performance
Time frame: 6 weeks
Muscle performance in vertical jump and running
1 secondary outcome
Biochemical analysis
Time frame: 1 week
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 18 Jan 2013.
- Background: PubMed 21086010Ferraresi C, de Brito Oliveira T, de Oliveira Zafalon L, de Menezes Reiff RB, Baldissera V, de Andrade Perez SE, Matheucci Junior E, Parizotto NA. Effects of low level laser therapy (808 nm) on physical strength training in humans. Lasers Med Sci. 2011 May;26(3):349-58. doi: 10.1007/s10103-010-0855-0. Epub 2010 Nov 18.
- Background: PubMed 21870127Vieira WH, Ferraresi C, Perez SE, Baldissera V, Parizotto NA. Effects of low-level laser therapy (808 nm) on isokinetic muscle performance of young women submitted to endurance training: a randomized controlled clinical trial. Lasers Med Sci. 2012 Mar;27(2):497-504. doi: 10.1007/s10103-011-0984-0. Epub 2011 Aug 26.
- Derived from this study: PubMed 25585514Ferraresi C, Beltrame T, Fabrizzi F, do Nascimento ES, Karsten M, Francisco Cde O, Borghi-Silva A, Catai AM, Cardoso DR, Ferreira AG, Hamblin MR, Bagnato VS, Parizotto NA. Muscular pre-conditioning using light-emitting diode therapy (LEDT) for high-intensity exercise: a randomized double-blind placebo-controlled trial with a single elite runner. Physiother Theory Pract. 2015 Jul;31(5):354-61. doi: 10.3109/09593985.2014.1003118. Epub 2015 Jan 14.
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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.
Cleber Ferraresi, MSc principal investigator
Universidade Federal de Sao Carlos
Nivaldo A Parizotto, PhD study director
Universidade Federal de Sao Carlos
Vanderlei S Bagnato, PhD 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 therapy in people with Athlete, run by Universidade Federal de Sao Carlos 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 2 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 18 Jan 2013. 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?
Functional performance (time frame: 6 weeks). 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 NCT01770977, 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 18 Jan 2013.