HealthyPhase 1NCT01391195
Effects of Low Level Laser Therapy (808nm) on Muscle Performance of Young Women Submitted to Physical Training
A Phase 1 study testing Phototherapy by low level laser therapy in people with Healthy, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The study hypothesis is an increase in muscle performance and a higher aerobic adaptation of young women submitted to chronic endurance training program associated to low level laser therapy when compared to chronic aerobic training alone. Read more about this study
- Who is it for?
- Ages 18 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Phototherapy by low level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2006to Oct 2007
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy young women volunteers
- women with a beginner or moderately trained pattern of physical activity
- body Mass Index (BMI) between 18 and 25kg/m2
Who cannot join
- previous injury to the femoral quadriceps or hamstrings muscles (within 6 months prior to study)
- osseous or articular disorder in the lower limbs
- cardiovascular system disorders or systemic disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Sao Carlos
São Carlos, São Paulo, 13565-905
About this study
The study hypothesis is an increase in muscle performance and a higher aerobic adaptation of young women submitted to chronic endurance training program associated to low level laser therapy when compared to chronic aerobic training alone.
Read the detailed description
The study assessed women muscle performance in isokinetic dynamometry, ventilatory parameters such as ventilatory threshold, VO2Peak, VO2Max, Ventilation. Maximal load in cycle ergometer test (Balke's protocol), Borg Scale and Heart rate were assessed too.
- Conditions
- Healthy
- Being tested
- Phototherapy by low level laser therapy
- Keywords
- low level laser therapy, muscle performance, fatigue index, endurance training, ventilatory threshold, VO2Max, VO2Peak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phototherapy by low level laser therapyDevice
Also called Laser, Laser therapy, Low level laser therapy
Phototherapy by low level laser therapy during 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| Laser therapy and aerobic capacity | Experimental | Effects of low level laser therapy on aerobic capacity of young women submitted to endurance training Receives: Device: Phototherapy by low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Index of knee extensor muscles
Fatigue Index of knee extensor muscles assessed in isokinetic dynamometry.
Measured: nine weeks
Ventilatory threshold
Ventilatory threshold quantified by a gas analyzer.
Measured: nine weeks
VO2max
VO2max quantified by a gas analyzer.
Measured: nine weeks
VO2peak
VO2peak quantified by a gas analyzer.
Measured: nine weeks
Maximum load of effort on cycle ergometer (Balke's protocol).
Maximum load of effort on cycle ergometer quantified in Watts.
Measured: nine weeks
Secondary outcomes (4)
Total work of knee extensor muscles
Total work of knee extensor muscles assessed in isokinetic dynamometry
Measured: nine weeks
Peak torque of knee extensor muscles
Peak torque of knee extensor muscles assessed in isokinetic dynamometry
Measured: nine weeks
Borg scale
Subjective effort perception assessed by Borg scale
Measured: nine weeks
Heart rate
Heart Rate assessed by cardiac frequency meter
Measured: nine weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJan 2006
- Primary completionApr 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Wouber Hérickson B Vieira, PhD, Principal investigator, Universidade Federal de Sao CarlosNivaldo A Parizotto, PhD, Study director, Universidade Federal de Sao CarlosCleber Ferraresi, Ms, Principal investigator, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391195
- Sponsor's protocol ID
- CAAE - 0100.0.135.000-05
- Status last verified
- Dec 2005
- First submitted
- 7 Jul 2011
- Last updated
- 13 Jul 2011
- 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 21086010Leal Junior EC, Lopes-Martins RA, de Almeida P, Ramos L, Iversen VV, Bjordal JM. Effect of low-level laser therapy (GaAs 904 nm) in skeletal muscle fatigue and biochemical markers of muscle damage in rats. Eur J Appl Physiol. 2010 Apr;108(6):1083-8. doi: 10.1007/s00421-009-1321-1. Epub 2009 Dec 19.
PubMed 20024577Lopes-Martins RA, Marcos RL, Leonardo PS, Prianti AC Jr, Muscara MN, Aimbire F, Frigo L, Iversen VV, Bjordal JM. Effect of low-level laser (Ga-Al-As 655 nm) on skeletal muscle fatigue induced by electrical stimulation in rats. J Appl Physiol (1985). 2006 Jul;101(1):283-8. doi: 10.1152/japplphysiol.01318.2005. Epub 2006 Apr 20.
PubMed 16627677Baroni BM, Leal Junior EC, De Marchi T, Lopes AL, Salvador M, Vaz MA. Low level laser therapy before eccentric exercise reduces muscle damage markers in humans. Eur J Appl Physiol. 2010 Nov;110(4):789-96. doi: 10.1007/s00421-010-1562-z. Epub 2010 Jul 3.
PubMed 20602109Baroni BM, Leal Junior EC, Geremia JM, Diefenthaeler F, Vaz MA. Effect of light-emitting diodes therapy (LEDT) on knee extensor muscle fatigue. Photomed Laser Surg. 2010 Oct;28(5):653-8. doi: 10.1089/pho.2009.2688. Epub 2010 Jul 13.
PubMed 20626264Leal 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, 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, 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 18817474
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Level Laser Therapy (808nm) on Muscle Performance of Young Women Submitted to Physical Training
- ClinicalTrials.gov ID
- NCT01391195
- Acronym / sponsor ID
- CAAE - 0100.0.135.000-05
- Conditions
- Healthy
- Keywords
- low level laser therapy, muscle performance, fatigue index, endurance training, ventilatory threshold, VO2Max, VO2Peak
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 11 Jul 2011 (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 an increase in muscle performance and a higher aerobic adaptation of young women submitted to chronic endurance training program associated to low level laser therapy when compared to chronic aerobic training alone.
Detailed description
The study assessed women muscle performance in isokinetic dynamometry, ventilatory parameters such as ventilatory threshold, VO2Peak, VO2Max, Ventilation. Maximal load in cycle ergometer test (Balke's protocol), Borg Scale and Heart rate were assessed too.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser therapy and aerobic capacity | Experimental | Device: Phototherapy by low level laser therapyEffects of low level laser therapy on aerobic capacity of young women submitted to endurance training |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy young women volunteers
- women with a beginner or moderately trained pattern of physical activity
- body Mass Index (BMI) between 18 and 25kg/m2
Key exclusion criteria (3 listed)
- previous injury to the femoral quadriceps or hamstrings muscles (within 6 months prior to study)
- osseous or articular disorder in the lower limbs
- cardiovascular system disorders or systemic 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 |
|---|---|---|
| Phototherapy by low level laser therapyAlso: Laser, Laser therapy, Low level laser therapyPhototherapy by low level laser therapy during 9 weeks | Device | Laser therapy and aerobic capacity |
Primary outcome
Fatigue Index of knee extensor muscles
Time frame: nine weeks
Fatigue Index of knee extensor muscles assessed in isokinetic dynamometry.
Ventilatory threshold
Time frame: nine weeks
Ventilatory threshold quantified by a gas analyzer.
VO2max
Time frame: nine weeks
VO2max quantified by a gas analyzer.
VO2peak
Time frame: nine weeks
VO2peak quantified by a gas analyzer.
Maximum load of effort on cycle ergometer (Balke's protocol).
Time frame: nine weeks
Maximum load of effort on cycle ergometer quantified in Watts.
4 secondary outcomes
Total work of knee extensor muscles
Time frame: nine weeks
Peak torque of knee extensor muscles
Time frame: nine weeks
Borg scale
Time frame: nine weeks
Heart rate
Time frame: nine 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 13 Jul 2011.
- 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 20024577Leal Junior EC, Lopes-Martins RA, de Almeida P, Ramos L, Iversen VV, Bjordal JM. Effect of low-level laser therapy (GaAs 904 nm) in skeletal muscle fatigue and biochemical markers of muscle damage in rats. Eur J Appl Physiol. 2010 Apr;108(6):1083-8. doi: 10.1007/s00421-009-1321-1. Epub 2009 Dec 19.
- Background: PubMed 16627677Lopes-Martins RA, Marcos RL, Leonardo PS, Prianti AC Jr, Muscara MN, Aimbire F, Frigo L, Iversen VV, Bjordal JM. Effect of low-level laser (Ga-Al-As 655 nm) on skeletal muscle fatigue induced by electrical stimulation in rats. J Appl Physiol (1985). 2006 Jul;101(1):283-8. doi: 10.1152/japplphysiol.01318.2005. Epub 2006 Apr 20.
- Background: PubMed 20602109Baroni BM, Leal Junior EC, De Marchi T, Lopes AL, Salvador M, Vaz MA. Low level laser therapy before eccentric exercise reduces muscle damage markers in humans. Eur J Appl Physiol. 2010 Nov;110(4):789-96. doi: 10.1007/s00421-010-1562-z. Epub 2010 Jul 3.
- Background: PubMed 20626264Baroni BM, Leal Junior EC, Geremia JM, Diefenthaeler F, Vaz MA. Effect of light-emitting diodes therapy (LEDT) on knee extensor muscle fatigue. Photomed Laser Surg. 2010 Oct;28(5):653-8. doi: 10.1089/pho.2009.2688. Epub 2010 Jul 13.
- 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 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 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.
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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 B Vieira, PhD principal investigator
Universidade Federal de Sao Carlos
Nivaldo A Parizotto, PhD study director
Universidade Federal de Sao Carlos
Cleber Ferraresi, Ms principal investigator
Universidade Federal de Sao Carlos
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 Phototherapy by low level laser 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 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 13 Jul 2011. 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.
What does the primary outcome measure?
Fatigue Index of knee extensor muscles (time frame: nine weeks). The study lists 5 primary outcomes in all. 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 NCT01391195, which also lists 8 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 13 Jul 2011.