HealthyNCT01770938
Effects of Phototherapy by Low-level Light-emitting Diode Therapy (LEDT) on Clinical, Biochemical, Biomechanical, Histologic and Genetic Responses of Muscle Performance of Young Males Submitted to Physical Strength Training
A study testing Effective light-emitting diode therapy in people with Healthy, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
Muscle performance is largely influenced by modulations in gene expressions of muscle tissue. In this context, light-emitting diode therapy (LEDT) has been used to improve muscle performance in experimental models and human researches. Read more about this study
- Who is it for?
- Ages 18 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Effective light-emitting diode therapy
- 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
- May 2012to Sep 2014
- 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 28 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males aged between 18 and 28 years with a body mass index (BMI) equal to or less than 26 kg/m2,
- moderated pattern of physical activity
Who cannot join
- previous injury to the femoral quadriceps or hamstring muscles (within 6 months prior to study),
- osseous or articular disorder in the lower limbs,
- cardiovascular system disorders,
- systemic disease, and
- taking prescription medicines or using dietary supplements such as muscle mass builders.
Trial locations and contacts
1 site in 1 country.
About this study
Muscle performance is largely influenced by modulations in gene expressions of muscle tissue. In this context, light-emitting diode therapy (LEDT) has been used to improve muscle performance in experimental models and human researches. Thereby, the investigators examined modulations in gene expression of muscle tissue as well as biochemical, biomechanic and histologic adaptations influenced by exercise associated to LEDT.
Read the detailed description
This study assessed muscle performance in isokinetic dynamometry and led press device, gene expression by RT-PCR, lactate, creatine kinase and morphology of muscle tissue by immunohistochemical analysis
- Conditions
- Healthy
- Being tested
- Effective light-emitting diode therapy, Placebo light-emitting diode therapy
- Keywords
- Light-emitting diode therapy, Muscle performance, Gene expression, Functional performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effective light-emitting diode therapyDevice
Also called LED, LED therapy, Light-emitting diode therapy
Placebo light-emitting diode therapyDevice
Also called LED, LED therapy, Light-emitting diode therapy
| Study group | Role | What they receive |
|---|---|---|
| Effective light-emitting diode therapy and training | Active comparator | Effects of effective light-emitting diode therapy therapy on muscle performance of young males submitted to physical strength training Receives: Device: Effective light-emitting diode therapy |
| Placebo light-emitting diode therapy and training | Placebo comparator | Effects of placebo light-emitting diode therapy on muscle performance of young males submitted to physical strength training Receives: Device: Placebo light-emitting diode therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulations on muscle gene expression by RT-PCR
Measured: 12 weeks
Secondary outcomes (4)
Muscle performance in leg press device
Measured: 12 weeks
Muscle performance in leg extension device
Measured: 12 weeks
Muscle performance in isokinetic dynamometer
Measured: 12 weeks
Gene expression
Gene expression of muscle tissue by RT-PCR
Measured: 12 weeks
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 2014
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 HealthyStudies 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
- 32 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
- NCT01770938
- Sponsor's protocol ID
- CAAE: 0326.0.135.000-11
- Status last verified
- Sep 2014
- First submitted
- 15 Sep 2012
- Last updated
- 23 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vieira 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, 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 21086010
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Phototherapy by Low-level Light-emitting Diode Therapy (LEDT) on Clinical, Biochemical, Biomechanical, Histologic and Genetic Responses of Muscle Performance of Young Males Submitted to Physical Strength Training
- ClinicalTrials.gov ID
- NCT01770938
- Acronym / sponsor ID
- CAAE: 0326.0.135.000-11
- Conditions
- Healthy
- Keywords
- Light-emitting diode therapy, Muscle performance, Gene expression, Functional performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 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 2014 (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.
Muscle performance is largely influenced by modulations in gene expressions of muscle tissue. In this context, light-emitting diode therapy (LEDT) has been used to improve muscle performance in experimental models and human researches. Thereby, the investigators examined modulations in gene expression of muscle tissue as well as biochemical, biomechanic and histologic adaptations influenced by exercise associated to LEDT.
Detailed description
This study assessed muscle performance in isokinetic dynamometry and led press device, gene expression by RT-PCR, lactate, creatine kinase and morphology of muscle tissue by immunohistochemical analysis
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 and training | Active comparator | Device: Effective light-emitting diode therapyEffects of effective light-emitting diode therapy therapy on muscle performance of young males submitted to physical strength training |
| Placebo light-emitting diode therapy and training | Placebo comparator | Device: Placebo light-emitting diode therapyEffects of placebo light-emitting diode therapy on muscle performance of young males submitted to physical strength training |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy males aged between 18 and 28 years with a body mass index (BMI) equal to or less than 26 kg/m2,
- moderated pattern of physical activity
Key exclusion criteria (5 listed)
- previous injury to the femoral quadriceps or hamstring muscles (within 6 months prior to study),
- osseous or articular disorder in the lower limbs,
- cardiovascular system disorders,
- systemic disease, and
- taking prescription medicines or using dietary supplements such as muscle mass builders.
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 |
|---|---|---|
| Effective light-emitting diode therapyAlso: LED, LED therapy, Light-emitting diode therapy | Device | Effective light-emitting diode therapy and training |
| Placebo light-emitting diode therapyAlso: LED, LED therapy, Light-emitting diode therapy | Device | Placebo light-emitting diode therapy and training |
Primary outcome
Modulations on muscle gene expression by RT-PCR
Time frame: 12 weeks
4 secondary outcomes
Muscle performance in leg press device
Time frame: 12 weeks
Muscle performance in leg extension device
Time frame: 12 weeks
Muscle performance in isokinetic dynamometer
Time frame: 12 weeks
Gene expression
Time frame: 12 weeks
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 23 Sep 2014.
- 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.
- 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.
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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 Effective light-emitting diode therapy in people with Healthy, 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 5 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 23 Sep 2014. 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?
Modulations on muscle gene expression by RT-PCR (time frame: 12 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 NCT01770938, 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 23 Sep 2014.