Healthy Young Male VolunteersPhase 1NCT01113021
Study of Effects of Low Level Laser Therapy in the Physical Training and the Muscle Responses in Humans.
A Phase 1 study testing Photon stimulation by low level laser therapy in people with Healthy Young Male Volunteers and Non Athletes, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The hypothesis of this study is that a chronic program of physical strength training, associates to effects of low level laser therapy (LLLT) can, possibly, provide changes in genic expression of muscle and to promote an enhancement of anaerobic muscle performance in humans. 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 Young Male Volunteers, Non Athletes, Free of Metabolic Disease
- What is being tested?
- Photon stimulation by low level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 young male volunteers;
- non-athletic physical activity;
- Body Mass Index (BMI) under 26;
- no prescription medicine or dietary supplement use (such as muscle mass builders.
Who cannot join
- metabolic disease;
- joint, bone and muscles of lower limbs with any disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1. Muscle Genic Expression Under Strength Training and Photostimulated by Laser.
The hypothesis of this study is that a chronic program of physical strength
training, associates to effects of low level laser therapy (LLLT) can,
possibly, provide changes in genic expression of muscle and to promote an
enhancement of anaerobic muscle performance in humans.
- Conditions
- Healthy Young Male Volunteers, Non Athletes, Free of Metabolic Disease, Joint, Bone and Muscles of Lower Limbs Free of Any Disease
- Being tested
- Photon stimulation by low level laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon stimulation by low level laser therapyDevice
| Study group | Role | What they receive |
|---|---|---|
| LLLT and Physical Strength training in Humans | Experimental | Not described Receives: Device: Photon stimulation by low level laser therapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy Young Male VolunteersStudies 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 1
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113021
- Sponsor's protocol ID
- CAAE 0072.0.135.000-08
- Status last verified
- Aug 2008
- First submitted
- 28 Apr 2010
- Last updated
- 29 Apr 2010
- Results posted
- No
Publications
Leal Junior EC, Lopes-Martins RA, Dalan F, Ferrari M, Sbabo FM, Generosi RA, Baroni BM, Penna SC, Iversen VV, Bjordal JM. Effect of 655-nm low-level laser therapy on exercise-induced skeletal muscle fatigue in humans. Photomed Laser Surg. 2008 Oct;26(5):419-24. doi: 10.1089/pho.2007.2160.
PubMed 18817474Leal Junior EC, Lopes-Martins RA, Vanin AA, Baroni BM, Grosselli D, De Marchi T, Iversen VV, Bjordal JM. Effect of 830 nm low-level laser therapy in exercise-induced skeletal muscle fatigue in humans. Lasers Med Sci. 2009 May;24(3):425-31. doi: 10.1007/s10103-008-0592-9. Epub 2008 Jul 23.
PubMed 18649044Leal Junior EC, Lopes-Martins RA, Baroni BM, De Marchi T, Taufer D, Manfro DS, Rech M, Danna V, Grosselli D, Generosi RA, Marcos RL, Ramos L, Bjordal JM. Effect of 830 nm low-level laser therapy applied before high-intensity exercises on skeletal muscle recovery in athletes. Lasers Med Sci. 2009 Nov;24(6):857-63. doi: 10.1007/s10103-008-0633-4. Epub 2008 Dec 5.
PubMed 19057981Leal Junior EC, Lopes-Martins RA, Baroni BM, De Marchi T, Rossi RP, Grosselli D, Generosi RA, de Godoi V, Basso M, Mancalossi JL, Bjordal JM. Comparison between single-diode low-level laser therapy (LLLT) and LED multi-diode (cluster) therapy (LEDT) applications before high-intensity exercise. Photomed Laser Surg. 2009 Aug;27(4):617-23. doi: 10.1089/pho.2008.2350.
PubMed 19302015
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1. Muscle Genic Expression Under Strength Training and Photostimulated by Laser.
- ClinicalTrials.gov ID
- NCT01113021
- Acronym / sponsor ID
- CAAE 0072.0.135.000-08
- Conditions
- Healthy Young Male Volunteers, Non Athletes, Free of Metabolic Disease, Joint, Bone and Muscles of Lower Limbs Free of Any Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- First posted
- 29 Apr 2010 (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.
The hypothesis of this study is that a chronic program of physical strength
training, associates to effects of low level laser therapy (LLLT) can,
possibly, provide changes in genic expression of muscle and to promote an
enhancement of anaerobic muscle performance in humans.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LLLT and Physical Strength training in Humans | Experimental | Device: Photon stimulation by low level laser therapy |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy young male volunteers;
- non-athletic physical activity;
- Body Mass Index (BMI) under 26;
- no prescription medicine or dietary supplement use (such as muscle mass builders.
Key exclusion criteria (2 listed)
- metabolic disease;
- joint, bone and muscles of lower limbs with any 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 |
|---|---|---|
| Photon stimulation by low level laser therapy | Device | LLLT and Physical Strength training in Humans |
Primary outcome
Not reported in the source record.
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 2010.
- Background: PubMed 18817474Leal Junior EC, Lopes-Martins RA, Dalan F, Ferrari M, Sbabo FM, Generosi RA, Baroni BM, Penna SC, Iversen VV, Bjordal JM. Effect of 655-nm low-level laser therapy on exercise-induced skeletal muscle fatigue in humans. Photomed Laser Surg. 2008 Oct;26(5):419-24. doi: 10.1089/pho.2007.2160.
- Background: PubMed 18649044Leal Junior EC, Lopes-Martins RA, Vanin AA, Baroni BM, Grosselli D, De Marchi T, Iversen VV, Bjordal JM. Effect of 830 nm low-level laser therapy in exercise-induced skeletal muscle fatigue in humans. Lasers Med Sci. 2009 May;24(3):425-31. doi: 10.1007/s10103-008-0592-9. Epub 2008 Jul 23.
- Background: PubMed 19057981Leal Junior EC, Lopes-Martins RA, Baroni BM, De Marchi T, Taufer D, Manfro DS, Rech M, Danna V, Grosselli D, Generosi RA, Marcos RL, Ramos L, Bjordal JM. Effect of 830 nm low-level laser therapy applied before high-intensity exercises on skeletal muscle recovery in athletes. Lasers Med Sci. 2009 Nov;24(6):857-63. doi: 10.1007/s10103-008-0633-4. Epub 2008 Dec 5.
- Background: PubMed 19302015Leal Junior EC, Lopes-Martins RA, Baroni BM, De Marchi T, Rossi RP, Grosselli D, Generosi RA, de Godoi V, Basso M, Mancalossi JL, Bjordal JM. Comparison between single-diode low-level laser therapy (LLLT) and LED multi-diode (cluster) therapy (LEDT) applications before high-intensity exercise. Photomed Laser Surg. 2009 Aug;27(4):617-23. doi: 10.1089/pho.2008.2350.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Photon stimulation by low level laser therapy in people with Healthy Young Male Volunteers and Non Athletes, 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 4 inclusion and 2 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 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01113021, which also lists 4 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 2010.