HealthyNCT01784432
Effects of Low-level Laser Therapy on Global Gene Expression of Young Males Submitted to Physical Strength Training
A study testing Low-level laser therapy and training and Training 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, low-level laser therapy 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?
- Low-level laser therapy and training and Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to 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 18 to 28 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males aged between 18 and 28 years;
- 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, low-level laser therapy has been used to improve muscle performance in experimental models and human researches. Thereby, the investigators examined modulations on global gene expression of muscle tissue influenced by exercise associated to low-level laser therapy.
Read the detailed description
This study assessed muscle performance in isokinetic dynamometry and leg press device; global gene expression of muscle tissue by microarray analysis
- Conditions
- Healthy
- Being tested
- Low-level laser therapy and training, Training
- Keywords
- low-level laser therapy, muscle performance, strength training, gene expression, microarrays
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapy and trainingDevice
Also called Laser, Laser therapy, Low-level laser therapy
TrainingOther
| Study group | Role | What they receive |
|---|---|---|
| Low-level laser therapy and training | Active comparator | Effects of low-level laser therapy on muscle performance during physical strength training and gene expression of muscle tissue. Receives: Device: Low-level laser therapy and training |
| Training without low-level laser therapy | Active comparator | Effects of physical strength training without low-level laser therapy on muscle performance and gene expression of muscle tissue Receives: Other: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global gene expression by microarray analysis
Measured: 12 weeks
Secondary outcomes (2)
Muscle performance in leg press device
Measured: 12 weeks
Muscle performance in isokinetic dynamometer
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 posted5 Feb 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionSep 2012
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
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 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, Faculty of Medicine of Ribeirão Preto (FMRP-USP), Fundação Hemocentro de Ribeirão Preto
- 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
- NCT01784432
- Sponsor's protocol ID
- CAAE: 0150.0.135.000-10
- Status last verified
- Feb 2013
- First submitted
- 15 Sep 2012
- Last updated
- 5 Feb 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 21870127
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-level Laser Therapy on Global Gene Expression of Young Males Submitted to Physical Strength Training
- ClinicalTrials.gov ID
- NCT01784432
- Acronym / sponsor ID
- CAAE: 0150.0.135.000-10
- Conditions
- Healthy
- Keywords
- low-level laser therapy, muscle performance, strength training, gene expression, microarrays
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 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, Faculty of Medicine of Ribeirão Preto (FMRP-USP), Fundação Hemocentro de Ribeirão Preto
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 5 Feb 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, low-level laser therapy has been used to improve muscle performance in experimental models and human researches. Thereby, the investigators examined modulations on global gene expression of muscle tissue influenced by exercise associated to low-level laser therapy.
Detailed description
This study assessed muscle performance in isokinetic dynamometry and leg press device; global gene expression of muscle tissue by microarray analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-level laser therapy and training | Active comparator | Device: Low-level laser therapy and trainingEffects of low-level laser therapy on muscle performance during physical strength training and gene expression of muscle tissue. |
| Training without low-level laser therapy | Active comparator | Other: TrainingEffects of physical strength training without low-level laser therapy on muscle performance and gene expression of muscle tissue |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy males aged between 18 and 28 years;
- 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 |
|---|---|---|
| Low-level laser therapy and trainingAlso: Laser, Laser therapy, Low-level laser therapy | Device | Low-level laser therapy and training |
| Training | Other | Training without low-level laser therapy |
Primary outcome
Global gene expression by microarray analysis
Time frame: 12 weeks
2 secondary outcomes
Muscle performance in leg press device
Time frame: 12 weeks
Muscle performance in isokinetic dynamometer
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 5 Feb 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.
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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 Low-level laser therapy and training and Training 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 3 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 5 Feb 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. 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?
Global gene expression by microarray analysis (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 NCT01784432, 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 5 Feb 2013.