HealthyNCT01972100
Use of Low-level Laser Therapy (808nm) to Muscle Fatigue Resistance
A study testing Low-level laser therapy (808nm) and isokinetic exercise in people with Healthy, run by Cleber Ferraresi at 1 site in Brazil.
Trial summary
The study hypothesis is a improved muscle fatigue resistance induced by low-level laser therapy applied between sets of intense exercises. Read more about this study
- Who is it for?
- Ages 18 to 28 years, men only
- Conditions the study is for
- Healthy
- What is being tested?
- Low-level laser therapy (808nm) and isokinetic exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to Oct 2013
- 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
- No healthy volunteers
- Adult
Who may be able to join
- healthy males
- physically active
- aged between 18-28 years old
Who cannot join
- smoker
- under medicine
- lower limb lesions limiting the flexion-extension of the knee joint
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal Univesity of Rio Grande do Norte
Rio Grande Do Norte, Natal, 59072-970
About this study
Official title: Use of Low-level Laser Therapy (808nm) to Muscle Fatigue Resistance: a Randomized Double-blind Crossover Trial
The study hypothesis is a improved muscle fatigue resistance induced by low-level laser therapy applied between sets of intense exercises.
- Conditions
- Healthy
- Being tested
- Low-level laser therapy (808nm), isokinetic exercise, Placebo low-level laser therapy
- Keywords
- Low-level laser therapy, Muscle fatigue resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapy (808nm)Device
Also called Low-level laser therapy;, Placebo low-level laser theraphy, Laser device (808nm; 100mW; DMC®, Brazil).
Use of low-level laser therapy(LLLT)or placebo-LLLT applied on quadriceps femoris muscles between sets of isokinetic knee flexion-extension exercise
isokinetic exerciseOther
Also called Isokinetic knee flexion-extension exercise
Placebo low-level laser therapyDevice
| Study group | Role | What they receive |
|---|---|---|
| Low-level laser therapy (LLLT) | Active comparator | Use of low-level laser therapy (LLLT) to induce a muscle fatigue resistance in intense exercises Receives: Device: Low-level laser therapy (808nm); Other: isokinetic exercise |
| Placebo low-level laser therapy (Placebo) | Active comparator | Use of low-level laser therapy (LLLT) placebo to induce a muscle fatigue resistance Receives: Other: isokinetic exercise; Device: Placebo low-level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum repetitions
Evaluation of maximum repetitions of knee flexion-extension in isokinetic dynamometer. Volunteers were assessed on Monday (pre evaluation - baseline), on Wednesday performed a session of exercises and on Friday were assessed again (final evaluation).
Measured: 1 week
Secondary outcomes (1)
Median Frequency
Evaluation of median frequency by surface electromyography of quadriceps femoris muscles during maximum repetitions of knee flexion-extension in isokinetic dynamometer. Volunteers were assessed on Monday (pre evaluation - baseline), on Wednesday performed a session of exercises and on Friday were assessed again (final evaluation).
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 posted30 Oct 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionOct 2013
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 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleber Ferraresi
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Rio Grande do Norte
- Responsible party
- Sponsor-investigator, Cleber Ferraresi, Universidade Federal de Sao Carlos
- Investigators
- Cleber Ferraresi, MD, Principal investigator, Universidade Federal de Sao CarlosWouber Hérickson de Brito Vieira, PhD, Study director, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972100
- Sponsor's protocol ID
- CEP/UFRN 401/09
- Status last verified
- Oct 2013
- First submitted
- 22 Oct 2013
- Last updated
- 30 Oct 2013
- Results posted
- No
Publications
Felismino AS, Costa EC, Aoki MS, Ferraresi C, de Araujo Moura Lemos TM, de Brito Vieira WH. Effect of low-level laser therapy (808 nm) on markers of muscle damage: a randomized double-blind placebo-controlled trial. Lasers Med Sci. 2014 May;29(3):933-8. doi: 10.1007/s10103-013-1430-2. Epub 2013 Sep 5.
PubMed 24005882Ferraresi C, Hamblin MR, Parizotto NA. Low-level laser (light) therapy (LLLT) on muscle tissue: performance, fatigue and repair benefited by the power of light. Photonics Lasers Med. 2012 Nov 1;1(4):267-286. doi: 10.1515/plm-2012-0032.
PubMed 23626925Vieira 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 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Low-level Laser Therapy (808nm) to Muscle Fatigue Resistance: a Randomized Double-blind Crossover Trial
- ClinicalTrials.gov ID
- NCT01972100
- Acronym / sponsor ID
- CEP/UFRN 401/09
- Conditions
- Healthy
- Keywords
- Low-level laser therapy, Muscle fatigue resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cleber FerraresiUniversity, hospital or other
- Collaborators
- Universidade Federal do Rio Grande do Norte
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 Oct 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 improved muscle fatigue resistance induced by low-level laser therapy applied between sets of intense exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-level laser therapy (LLLT) | Active comparator | Device: Low-level laser therapy (808nm), Other: isokinetic exerciseUse of low-level laser therapy (LLLT) to induce a muscle fatigue resistance in intense exercises |
| Placebo low-level laser therapy (Placebo) | Active comparator | Other: isokinetic exercise, Device: Placebo low-level laser therapyUse of low-level laser therapy (LLLT) placebo to induce a muscle fatigue resistance |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy males
- physically active
- aged between 18-28 years old
Key exclusion criteria (3 listed)
- smoker
- under medicine
- lower limb lesions limiting the flexion-extension of the knee joint
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)Also: Low-level laser therapy;, Placebo low-level laser theraphy, Laser device (808nm; 100mW; DMC®, Brazil).Use of low-level laser therapy(LLLT)or placebo-LLLT applied on quadriceps femoris muscles between sets of isokinetic knee flexion-extension exercise | Device | Low-level laser therapy (LLLT) |
| isokinetic exerciseAlso: Isokinetic knee flexion-extension exercise | Other | Low-level laser therapy (LLLT), Placebo low-level laser therapy (Placebo) |
| Placebo low-level laser therapy | Device | Placebo low-level laser therapy (Placebo) |
Primary outcome
Maximum repetitions
Time frame: 1 week
Evaluation of maximum repetitions of knee flexion-extension in isokinetic dynamometer. Volunteers were assessed on Monday (pre evaluation - baseline), on Wednesday performed a session of exercises and on Friday were assessed again (final evaluation).
1 secondary outcome
Median Frequency
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 30 Oct 2013.
- Background: PubMed 24005882Felismino AS, Costa EC, Aoki MS, Ferraresi C, de Araujo Moura Lemos TM, de Brito Vieira WH. Effect of low-level laser therapy (808 nm) on markers of muscle damage: a randomized double-blind placebo-controlled trial. Lasers Med Sci. 2014 May;29(3):933-8. doi: 10.1007/s10103-013-1430-2. Epub 2013 Sep 5.
- Background: PubMed 23626925Ferraresi C, Hamblin MR, Parizotto NA. Low-level laser (light) therapy (LLLT) on muscle tissue: performance, fatigue and repair benefited by the power of light. Photonics Lasers Med. 2012 Nov 1;1(4):267-286. doi: 10.1515/plm-2012-0032.
- 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.
Cleber Ferraresi, MD principal investigator
Universidade Federal de Sao Carlos
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 isokinetic exercise in people with Healthy, run by Cleber Ferraresi 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 3 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 30 Oct 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?
Maximum repetitions (time frame: 1 week). 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 NCT01972100, 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 30 Oct 2013.