Muscle; Fatigue, HeartLLLTNCT01844271
Low Level Laser Therapy in Muscle Fatigue and Muscle Recovery
A study testing Low Level Laser (LLL) in people with Muscle; Fatigue, Heart and Skeletal Muscle Recovery, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Muscle fatigue and muscle recovery after exercise are recent areas of research involving Low Level Laser Therapy (LLLT) and many factors remain unknown, such as optimal doses, power and application parameters, mechanisms of action, effects on long-term exercise and the long-term effects on skeletal muscle recovery. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- Muscle; Fatigue, Heart, Skeletal Muscle Recovery
- What is being tested?
- Low Level Laser (LLL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Dec 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 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- professional soccer players aged between 18 and 35 years old;
- not presenting historical musculoskeletal injury in regions of the hip and knee in the 2 months preceding the study;
- not making use of pharmacological agents and/or nutritional supplements;
- participating with minimum frequency of 80% of the training team
Who cannot join
- athletes who experience musculoskeletal injury during the study;
- athletes who for whatever reason have their training routine changed with respect to the rest of the team during the course of study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Level Laser Therapy in Muscle Fatigue and Muscle Recovery After Exercise: What is the Ideal Dose?
Muscle fatigue and muscle recovery after exercise are recent areas of research involving Low Level Laser Therapy (LLLT) and many factors remain unknown, such as optimal doses, power and application parameters, mechanisms of action, effects on long-term exercise and the long-term effects on skeletal muscle recovery.
The present research project aims to assess the effects of long-term recovery of LLLT in skeletal muscle after exercise and identify the optimal dose application of LLLT.
Read more
After defining the best dose of application, we recruited two groups which will be irradiated with different power, 100mW and 400mW in order to seek the optimal parameter of low level laser therapy in performance.
The investigators believed that the Low Level Laser Therapy can delay the physiological process of muscle fatigue, reduce injury or skeletal muscle microdamage arising from physical effort and accelerate muscle recovery after exercise.
Read the detailed description
To achieve the proposed objectives it was performed a randomized, double-blinded, placebo-controlled trial, with voluntary participation of high-level soccer athletes.
Participants received an application of low level laser prior to execution of a strenuous exercise. It was used a laser with a cluster of 5 diodes (810 nm, 200 mW each diode) with different doses (placebo, 2J, 6J, 10J) and power of 200mW.
In a second step, with the optimal dose already defined, this was used to be applied with different powers in two experimental groups, 100mW and 400mW.
The investigators analysed parameters related to volunteers exercise performance (torque peak / maximum voluntary contraction), delayed onset muscle soreness, and biochemical markers of muscle damage (CK and LDH), inflammation (interleukin 1 and 6, alpha tumoral necrosis factor) and oxidative stress (TBARS, CAT, SOD and carbonylated proteins). The analysis was performed before exercise protocols, after 1 minute, and 1, 24, 48, 72 and 96 hours after the end of exercise protocol in both parts of the study.
- Conditions
- Muscle; Fatigue, Heart, Skeletal Muscle Recovery
- Being tested
- Low Level Laser (LLL)
- Keywords
- LLLT, muscle fatigue and recovery, phototherapy parameter
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser (LLL)Device
Comparison of different dosages of a Low Level Laser applied in six different locations of the knee extensor muscles of the lower limb non-dominant before a strenuous exercise.
We performed stretching and warming up of the muscles involved, assessment of muscle pain, withdrawal of blood sample, test muscle function (MVC), application of dose of low level laser designated for each volunteer (0, 2, 6 or 10), performing eccentric contractions protocol in isokinetic dynamometer . After the protocol we evaluated muscle function, the DOMS, and blood analyzes in 1 minute, 1 hour, 24 hours, 48 hours 72 hours and 96 hours.
In a second stage, the optimal dose defined by the first part of the study will be tested in two different powers, 100 and 400mW. The study was repeated in two experimental groups using the optimal dose established and the powers of 100 and 400mW that was randomly distributed in groups.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Low Level Laser | Placebo comparator | Application of low level laser without any dose (0 Joule) before strenuous exercise. A laser device with a cluster of 5 diodes (810 nm, 200 mW) each diode was used for this study. Receives: Device: Low Level Laser (LLL) |
| 2 Joules Low Level Laser | Experimental | Application of 2 Joules of Low Level Laser Therapy before strenuous exercise with a cluster of 5 diode (810 nm, 200 mW each diode). Receives: Device: Low Level Laser (LLL) |
| 6 Joules Low Level Laser Therapy | Experimental | Application of 6 Joules of Low Level Laser Therapy before strenuous exercise with a cluster of 5 diode (810 nm, 200 mW each diode). Receives: Device: Low Level Laser (LLL) |
| 10 Joules Low Level Therapy | Experimental | Application of 10 Joules of Low Level Laser Therapy before strenuous exercise with a cluster of 5 diode (810 nm, 200 mW each diode). Receives: Device: Low Level Laser (LLL) |
| Power of 100mW | Experimental | After assigning ideal dose of application it was delimited two experimental groups which was irradiated with the dose established by the first part of the study and power of 100mW. Receives: Device: Low Level Laser (LLL) |
| Power of 400mW | Experimental | After assigning ideal dose of application it was delimited two experimental groups which were irradiated with the dose established by the first part of the study and power of 400mW. Receives: Device: Low Level Laser (LLL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise performance (MVC and peak torque)
The investigators used an isokinetic dynamometer to assess muscle function and the execution of the exercise protocol, because this tool is currently recognized as the most reliable, reliability and reproducibility for measuring the performance musculoskeletal.
The maximum voluntary contraction (MVC) was performed before the exercise protocol and repeated 1 minute, 1 hour, 24, 48, 72 and 96 hours after the eccentric contraction protocol.
The peak torque was measured after evaluation of muscular pain, blood tests, stretching and warming, MVC and application of a predetermined dose of low level therapy (LLLT). It was done after 3 minutes of LLLT application through execution of a eccentric contraction of 5 series of 15 repetitions.
After the execution of the exercise protocol it was repeated the collection of blood samples, measuring DOMS and muscle function test (MVC) in 1 minute, 1 hour, 24 hours, 48 hours, 72 hours and 96 hours from the protocol.
Measured: Maximum voluntary contraction (MVC) was performed before the exercise protocol and repeted 1 minute, 1 hour, 24, 48, 72 and 96 hours after the eccentric contraction protocol. The peak torque was performed after 3 minutes of LLLT application.
Secondary outcomes (1)
Blood tests (composite measures)
Biochemical markers of muscle damage (CK and LDH), inflammation (IL-1, IL-6 and tumor necrosis factor(TNF)-alpha) and oxidative stress (TBARS, CAT, SOD and carbonylated proteins). The analysis were performed before exercise protocols, after 1 minute, and 1, 24, 48, 72 and 96 hours after the end of exercise protocol.
Measured: Analysis of biochemical markers of muscle damage, inflammation and oxidative stress before exercise protocols, after 1 minute, and 1, 24, 48, 72 and 96 hours after the end of exercise protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2013
- Study completionDec 2013
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 Muscle; Fatigue, HeartStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Adriane Aver Vanin, University of Nove de Julho
- Investigators
- Adriane A Vanin, PT, Study chair, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844271
- Sponsor's protocol ID
- Uninove
- Acronym
- LLLT
- Status last verified
- Dec 2014
- First submitted
- 24 Apr 2013
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Baroni 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 20602109de Oliveira AR, Vanin AA, De Marchi T, Antonialli FC, Grandinetti Vdos S, de Paiva PR, Albuquerque Pontes GM, Santos LA, Aleixo Junior Ide O, de Carvalho Pde T, Bjordal JM, Leal-Junior EC. What is the ideal dose and power output of low-level laser therapy (810 nm) on muscle performance and post-exercise recovery? Study protocol for a double-blind, randomized, placebo-controlled trial. Trials. 2014 Feb 27;15:69. doi: 10.1186/1745-6215-15-69.
PubMed 24576321
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Laser Therapy in Muscle Fatigue and Muscle Recovery After Exercise: What is the Ideal Dose?
- ClinicalTrials.gov ID
- NCT01844271
- Acronym / sponsor ID
- LLLT / Uninove
- Conditions
- Muscle; Fatigue, Heart, Skeletal Muscle Recovery
- Keywords
- LLLT, muscle fatigue and recovery, phototherapy parameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 May 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 fatigue and muscle recovery after exercise are recent areas of research involving Low Level Laser Therapy (LLLT) and many factors remain unknown, such as optimal doses, power and application parameters, mechanisms of action, effects on long-term exercise and the long-term effects on skeletal muscle recovery.
The present research project aims to assess the effects of long-term recovery of LLLT in skeletal muscle after exercise and identify the optimal dose application of LLLT.
After defining the best dose of application, we recruited two groups which will be irradiated with different power, 100mW and 400mW in order to seek the optimal parameter of low level laser therapy in performance.
The investigators believed that the Low Level Laser Therapy can delay the physiological process of muscle fatigue, reduce injury or skeletal muscle microdamage arising from physical effort and accelerate muscle recovery after exercise.
Detailed description
To achieve the proposed objectives it was performed a randomized, double-blinded, placebo-controlled trial, with voluntary participation of high-level soccer athletes.
Participants received an application of low level laser prior to execution of a strenuous exercise. It was used a laser with a cluster of 5 diodes (810 nm, 200 mW each diode) with different doses (placebo, 2J, 6J, 10J) and power of 200mW.
In a second step, with the optimal dose already defined, this was used to be applied with different powers in two experimental groups, 100mW and 400mW.
The investigators analysed parameters related to volunteers exercise performance (torque peak / maximum voluntary contraction), delayed onset muscle soreness, and biochemical markers of muscle damage (CK and LDH), inflammation (interleukin 1 and 6, alpha tumoral necrosis factor) and oxidative stress (TBARS, CAT, SOD and carbonylated proteins). The analysis was performed before exercise protocols, after 1 minute, and 1, 24, 48, 72 and 96 hours after the end of exercise protocol in both parts of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo Low Level Laser | Placebo comparator | Device: Low Level Laser (LLL)Application of low level laser without any dose (0 Joule) before strenuous exercise. A laser device with a cluster of 5 diodes (810 nm, 200 mW) each diode was used for this study. |
| 2 Joules Low Level Laser | Experimental | Device: Low Level Laser (LLL)Application of 2 Joules of Low Level Laser Therapy before strenuous exercise with a cluster of 5 diode (810 nm, 200 mW each diode). |
| 6 Joules Low Level Laser Therapy | Experimental | Device: Low Level Laser (LLL)Application of 6 Joules of Low Level Laser Therapy before strenuous exercise with a cluster of 5 diode (810 nm, 200 mW each diode). |
| 10 Joules Low Level Therapy | Experimental | Device: Low Level Laser (LLL)Application of 10 Joules of Low Level Laser Therapy before strenuous exercise with a cluster of 5 diode (810 nm, 200 mW each diode). |
| Power of 100mW | Experimental | Device: Low Level Laser (LLL)After assigning ideal dose of application it was delimited two experimental groups which was irradiated with the dose established by the first part of the study and power of 100mW. |
| Power of 400mW | Experimental | Device: Low Level Laser (LLL)After assigning ideal dose of application it was delimited two experimental groups which were irradiated with the dose established by the first part of the study and power of 400mW. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- professional soccer players aged between 18 and 35 years old;
- not presenting historical musculoskeletal injury in regions of the hip and knee in the 2 months preceding the study;
- not making use of pharmacological agents and/or nutritional supplements;
- participating with minimum frequency of 80% of the training team
Key exclusion criteria (2 listed)
- athletes who experience musculoskeletal injury during the study;
- athletes who for whatever reason have their training routine changed with respect to the rest of the team during the course of study.
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 (LLL)Comparison of different dosages of a Low Level Laser applied in six different locations of the knee extensor muscles of the lower limb non-dominant before a strenuous exercise. We performed stretching and warming up of the muscles involved, assessment of muscle pain, withdrawal of blood sample, test muscle function (MVC), application of dose of low level laser designated for each volunteer (0, 2, 6 or 10), performing eccentric contractions protocol in isokinetic dynamometer . After the protocol we evaluated muscle function, the DOMS, and blood analyzes in 1 minute, 1 hour, 24 hours, 48 hours 72 hours and 96 hours. In a second stage, the optimal dose defined by the first part of the study will be tested in two different powers, 100 and 400mW. The study was repeated in two experimental groups using the optimal dose established and the powers of 100 and 400mW that was randomly distributed in groups. | Device | 10 Joules Low Level Therapy, 2 Joules Low Level Laser, 6 Joules Low Level Laser Therapy, Placebo Low Level Laser, Power of 100mW, Power of 400mW |
Primary outcome
Exercise performance (MVC and peak torque)
Time frame: Maximum voluntary contraction (MVC) was performed before the exercise protocol and repeted 1 minute, 1 hour, 24, 48, 72 and 96 hours after the eccentric contraction protocol. The peak torque was performed after 3 minutes of LLLT application.
The investigators used an isokinetic dynamometer to assess muscle function and the execution of the exercise protocol, because this tool is currently recognized as the most reliable, reliability and reproducibility for measuring the performance musculoskeletal. The maximum voluntary contraction (MVC) was performed before the exercise protocol and repeated 1 minute, 1 hour, 24, 48, 72 and 96 hours after the eccentric contraction protocol. The peak torque was measured after evaluation of muscular pain, blood tests, stretching and warming, MVC and application of a predetermined dose of low level therapy (LLLT). It was done after 3 minutes of LLLT application through execution of a eccentric contraction of 5 series of 15 repetitions. After the execution of the exercise protocol it was repeated the collection of blood samples, measuring DOMS and muscle function test (MVC) in 1 minute, 1 hour, 24 hours, 48 hours, 72 hours and 96 hours from the protocol.
1 secondary outcome
Blood tests (composite measures)
Time frame: Analysis of biochemical markers of muscle damage, inflammation and oxidative stress before exercise protocols, after 1 minute, and 1, 24, 48, 72 and 96 hours after the end of exercise protocol.
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 8 Dec 2014.
- Results publication: 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.
- Derived from this study: PubMed 24576321de Oliveira AR, Vanin AA, De Marchi T, Antonialli FC, Grandinetti Vdos S, de Paiva PR, Albuquerque Pontes GM, Santos LA, Aleixo Junior Ide O, de Carvalho Pde T, Bjordal JM, Leal-Junior EC. What is the ideal dose and power output of low-level laser therapy (810 nm) on muscle performance and post-exercise recovery? Study protocol for a double-blind, randomized, placebo-controlled trial. Trials. 2014 Feb 27;15:69. doi: 10.1186/1745-6215-15-69.
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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.
Adriane A Vanin, PT study chair
Nove de Julho University
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 (LLL) in people with Muscle; Fatigue, Heart and Skeletal Muscle Recovery, run by University of Nove de Julho 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 8 Dec 2014. 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. Some participants in this study may receive a placebo. 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?
Exercise performance (MVC and peak torque) (time frame: Maximum voluntary contraction (MVC) was performed before the exercise protocol and repeted 1 minute, 1 hour, 24, 48, 72 and 96 hours after the eccentric contraction protocol. The peak torque was performed after 3 minutes of LLLT application.). 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 NCT01844271, 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 8 Dec 2014.