HealthyNCT01808716
Effect of Low-level Laser Therapy (808nm) on Marker of Muscle Damage
A study testing Low-level laser therapy (808nm) and exercise in people with Healthy, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The study hypothesis is a decreased muscle damage induced by exercises when low-level laser therapy is applied on body muscles before exercises. Read more about this study
- Who is it for?
- Ages 25 to 35 years, men only
- Conditions the study is for
- Healthy
- What is being tested?
- Low-level laser therapy (808nm) and exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Jun 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 25 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- healthy males,
- physically active,
- aged between 25-40 years.
Who cannot join
- smoker, or
- under medicine as anti-inflammatory and/or any drug that could affect normal and physiological conditions and lesion in upper limbs.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal Univesity of Rio Grande do Norte
Natal, Rio Grande do Norte, 59072-970
About this study
Official title: Effect of Low-level Laser Therapy (808nm) on Marker of Muscle Damage: Randomized Double-blind Placebo-controlled Study
The study hypothesis is a decreased muscle damage induced by exercises when low-level laser therapy is applied on body muscles before exercises.
Read the detailed description
The study assessed males submitted to exercise to induce muscle damage. Creatine kinase levels in blood was quantified in order to identify the magnitude of muscle damage.
- Conditions
- Healthy
- Being tested
- Low-level laser therapy (808nm) and exercise
- Keywords
- low-level laser therapy, muscle damage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapy (808nm) and exerciseDevice
Also called Laser device (808nm; 100mW; DMC®, Brazil), Low-level laser therapy, Muscle damage, Muscle recovery
Use of low-level laser therapy(LLLT)or placebo-LLLT applied on biceps brachii for muscle damage recovery
| Study group | Role | What they receive |
|---|---|---|
| Low-level laser therapy (LLLT) on muscle damage | Active comparator | Effects of low-level laser therapy (LLLT)on muscle damage Receives: Device: Low-level laser therapy (808nm) and exercise |
| Low-level laser therapy (LLLT) placebo on muscle damage | Active comparator | Effects of low-level laser therapy (LLLT) placebo on muscle damage Receives: Device: Low-level laser therapy (808nm) and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatine Kinase analysis in blood
Evaluation of Creatine Kinase (CK) levels in blood before, immediately after and 24h, 48h and 72h after protocol of exercise to induce muscle damage
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startFeb 2011
- Primary completionOct 2011
- Study completionJun 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Rio Grande do Norte
- Responsible party
- Principal investigator, Cleber Ferraresi, Universidade Federal de Sao Carlos
- Investigators
- Wouber Hérickson de Brito Vieira, PhD, Study director, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808716
- Sponsor's protocol ID
- CEP/UFRN 176/10
- Status last verified
- Mar 2013
- First submitted
- 1 Mar 2013
- Last updated
- 11 Mar 2013
- Results posted
- No
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 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-level Laser Therapy (808nm) on Marker of Muscle Damage: Randomized Double-blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01808716
- Acronym / sponsor ID
- CEP/UFRN 176/10
- Conditions
- Healthy
- Keywords
- low-level laser therapy, muscle damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Universidade Federal do Rio Grande do Norte
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Mar 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.
The study hypothesis is a decreased muscle damage induced by exercises when low-level laser therapy is applied on body muscles before exercises.
Detailed description
The study assessed males submitted to exercise to induce muscle damage. Creatine kinase levels in blood was quantified in order to identify the magnitude of muscle damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-level laser therapy (LLLT) on muscle damage | Active comparator | Device: Low-level laser therapy (808nm) and exerciseEffects of low-level laser therapy (LLLT)on muscle damage |
| Low-level laser therapy (LLLT) placebo on muscle damage | Active comparator | Device: Low-level laser therapy (808nm) and exerciseEffects of low-level laser therapy (LLLT) placebo on muscle damage |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy males,
- physically active,
- aged between 25-40 years.
Key exclusion criteria (2 listed)
- smoker, or
- under medicine as anti-inflammatory and/or any drug that could affect normal and physiological conditions and lesion in upper limbs.
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 (808nm) and exerciseAlso: Laser device (808nm; 100mW; DMC®, Brazil), Low-level laser therapy, Muscle damage, Muscle recoveryUse of low-level laser therapy(LLLT)or placebo-LLLT applied on biceps brachii for muscle damage recovery | Device | Low-level laser therapy (LLLT) on muscle damage, Low-level laser therapy (LLLT) placebo on muscle damage |
Primary outcome
Creatine Kinase analysis in blood
Time frame: 72 hours
Evaluation of Creatine Kinase (CK) levels in blood before, immediately after and 24h, 48h and 72h after protocol of exercise to induce muscle damage
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 11 Mar 2013.
- 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.
- Research Ethics Committee of the Federal University of Rio Grande do NorteLink 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.
Wouber Hérickson de Brito Vieira, PhD study director
Universidade Federal do Rio Grande do Norte
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 (808nm) and exercise 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 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 11 Mar 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?
Creatine Kinase analysis in blood (time frame: 72 hours). 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 NCT01808716, 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 11 Mar 2013.