Muscle FatigueNCT03461731
Investigation of the Role of 905-nm Laser Light in the Delay of Muscle Fatigue
A study testing 800 nm laser, combination laser and 905 nm laser in people with Muscle Fatigue, run by College of Charleston at 1 site in United States.
Trial summary
800-nm laser light has been shown to delay muscle fatigue when applied before exercise. The effect of illumination during the aerobic phase of strenuous exercise has not been studied. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Fatigue
- What is being tested?
- 800 nm laser, combination laser and 905 nm laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2017to 31 Jul 2017
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 25 years
Who cannot join
- Upper extremity surgery
- Upper body musculoskeletal injury to the non-dominant arm within the past year
- Tattoos on the forearm
- Photosensitizing medications (listed on the consent form)
Trial locations and contacts
1 site in 1 country.
United States1 site
College of Charleston
Charleston, South Carolina, 29424
About this study
800-nm laser light has been shown to delay muscle fatigue when applied before exercise. The effect of illumination during the aerobic phase of strenuous exercise has not been studied. The investigators hypothesize that the increased energy donated to cells during the aerobic phase will significantly delay muscle fatigue. A novel aspect of this study is to include simultaneous treatment with near infrared light at 800 nm and 905 nm. Fatigue index and change in lactate blood level will be used to compare the different laser treatments for each participant. Monte Carlo simulations of light energy reaching the muscle will be carried out, based on skin-fold thickness measurements of each participant. The investigators believe this will be the first report of optical dosimetry as a function of adipose thickness and it will enable estimation how much of the light applied to the skin surface is able to penetrate to the muscles that are thought to be affected. The results of this study will help clinicians to optimize treatment for individual patients.
Read the detailed description
Rationale, Objectives and Significance A recent study has shown that low intensity Near Infrared (NIR) light at 810 nm applied before exercise results in an increase in performance and decrease in oxidative stress and muscle damage (1). Another study by the same group with 830 nm light showed a delay in exercise-induced muscle fatigue when applied before exercise (2). A number of studies have shown varying results with near infrared light for pain relief, inflammation and wound healing. The results often vary in part due to the difference in the wavelength and intensity of the light source and variation in the depth of penetration of the light. Red and NIR light is known to penetrate significantly into biological tissues. For example, a recent study presents qualitative evidence that 830 nm light penetrated significantly through cadaver soft tissue and a human hand in vivo (3). The optical properties of various human tissues have been studied at 800 to 950 nm so it is possible for the investigators to calculate the precise distribution of near infrared light in relation to the physiological effects. The investigators are well equipped to carry this out with an original, calibrated Monte Carlo program. The mechanism of action for low intensity red to NIR light has been fairly well studied and is thought to occur through absorption of the light by mitochondrial cytochrome c oxidase which leads to energy production in the illuminated cells (4). The effect of illumination DURING the aerobic phase of strenuous exercise has not been studied. The investigators hypothesize that the increased energy donated to cells during the aerobic phase will significantly delay muscle fatigue.
fatigue index and lactate blood level will be used to compare the different laser treatments. Another novel aspect of this study is to include NIR light at 905 nm. A hypothesized mechanism for delay of muscle fatigue is a light-initiated release of oxygen from hemoglobin molecules by 905-nm laser light, resulting in increased oxygenation of the local tissue. The laser may heat the tissue slightly so it is not clear whether oxygen release is due to a thermal or photochemical mechanism. A recent study of low level light (660 nm, 350 mW, 15 minutes) resulted in no measurable change in local tissue oxygenation for healthy participants (5). Another recent study with a more intense light source (K-laser at 800, 907 and 970 nm, 3 W, 4 minutes) demonstrated increased blood flow in the upper arm following irradiation with the NIR laser (6). However the authors did not measure the temperature of the irradiated tissue.
In the proposed study the investigators will keep the intensity of 800 nm light constant in all of the trials. The proposed study will include collection of surface temperature during the treatment to begin to document whether tissue heating is involved in the mechanism. The adipose thickness (calculated from skin fold thickness) will be used with the Monte Carlo simulation to calculate the fraction of light that is expected to reach the muscle for each participant. This will be the first report of optical dosimetry as a function of adipose thickness and it will enable estimation of how much of the light applied to the skin surface is able to penetrate to the muscles that are thought to be affected. The results of this study will help clinicians to optimize treatment for individual patients.
- Thiago de Marchi, Ernesto Cesar Pinto Leal Junior et al, Low level laser therapy (LLLT) in human progressive intensity running: effects on exercise performance, skeletal muscle status and oxidative stress. (2012) Lasers in Medical Science 27:231236.
- Ernesto Cesar Pinto Leal Junior, Rodrigo Alvaro Brandao LopexMartins et al. Effect of 830nm lowlevel therapy in exercise induced skeletal muscle fatigue in humans. (2009) Lasers in Medical Science 24:425431.
- Jared Jagdeo, Lauren Adams, et al. Transcranial red and near infrared light transmission in a cadaveric model. (2012) PLOS ONE 7:10 e47460
- Janis Eells, Margaret WongRiley, et al. Mitochondrial signal transduction in accelerated wound and retinal healing by near infrared light therapy. (2004) Mitochondrion Sep; 4(56):55967.
- Franziska Heu, Clemens Forster, Barbara Namer, Adrian Dragu, Werner Lang. Effect of lowlevel laser therapy on blood flow and oxygenhemoglobin saturation of the foot skin in healthy subjects: a pilot study. (2013) Laser Therapy 22(1): 2130.
- Kelly Larkin, Jeffrey Martin, Elizabeth Zeanah, Jerry Tue, Randy Braith, Paul Borsa. Limb blood flow after class 4 laser therapy. (2012) Journal of Athletic Training. 47(2): 178183.
- Conditions
- Muscle Fatigue
- Being tested
- Control, 800 nm laser, combination laser, 905 nm laser
- Keywords
- Low-Level Light Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDevice
laser beam only
800 nm laserDevice
800 nm laser applied to forearm at 4.4 Joules per square cm during 40 hand grips
combination laserDevice
800 nm and 905 nm laser applied to forearm at 4.4 Joules per square cm during 40 hand grips
905 nm laserDevice
905 nm laser applied to forearm at 4.4 Joules per square cm during 40 hand grips
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Participant will receive a sham treatment that consists of just the 660-nm aiming beam Receives: Device: Control |
| 800 nm laser | Experimental | 800 nm laser will be applied at 4.4 Joules per square cm on the forearm during 40 repetitive hand grips Receives: Device: 800 nm laser |
| combination laser | Experimental | 905 nm and 800 nm will be applied at 4.4 joules per square cm with a total of 8.8 Joules per square cm during 40 repetitive handgrips. Receives: Device: combination laser |
| 905 nm laser | Experimental | 905 nm laser will be applied at 4.4 Joules per square cm on the forearm during 40 repetitive hand grips Receives: Device: 905 nm laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle fatigue
Grip force measured by a dynamometer
Measured: Muscle fatigue is calculated from force data immediately after each treatment.
Secondary outcomes (1)
Lactate
Change in blood lactate level
Measured: Lactate is measured immediately before each laser treatment and three minutes after each treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start20 Feb 2017
- Primary completion30 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Muscle FatigueStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant receives placebo and two different light treatments in random order
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- College of Charleston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Ramball Jones, College of Charleston
- Investigators
- Linda R Jones, Ph.D., Principal investigator, College of Charleston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461731
- Sponsor's protocol ID
- IRB-2017-01-03-123913
- Status last verified
- Mar 2018
- First submitted
- 27 Feb 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after de-identification
Publications
De Marchi T, Leal Junior EC, Bortoli C, Tomazoni SS, Lopes-Martins RA, Salvador M. Low-level laser therapy (LLLT) in human progressive-intensity running: effects on exercise performance, skeletal muscle status, and oxidative stress. Lasers Med Sci. 2012 Jan;27(1):231-6. doi: 10.1007/s10103-011-0955-5. Epub 2011 Jul 8.
PubMed 21739259Leal 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 18649044Jagdeo JR, Adams LE, Brody NI, Siegel DM. Transcranial red and near infrared light transmission in a cadaveric model. PLoS One. 2012;7(10):e47460. doi: 10.1371/journal.pone.0047460. Epub 2012 Oct 15.
PubMed 23077622Eells JT, Wong-Riley MT, VerHoeve J, Henry M, Buchman EV, Kane MP, Gould LJ, Das R, Jett M, Hodgson BD, Margolis D, Whelan HT. Mitochondrial signal transduction in accelerated wound and retinal healing by near-infrared light therapy. Mitochondrion. 2004 Sep;4(5-6):559-67. doi: 10.1016/j.mito.2004.07.033.
PubMed 16120414Heu F, Forster C, Namer B, Dragu A, Lang W. Effect of low-level laser therapy on blood flow and oxygen- hemoglobin saturation of the foot skin in healthy subjects: a pilot study. Laser Ther. 2013;22(1):21-30. doi: 10.5978/islsm.13-or-03.
PubMed 24155546Larkin KA, Martin JS, Zeanah EH, True JM, Braith RW, Borsa PA. Limb blood flow after class 4 laser therapy. J Athl Train. 2012 Mar-Apr;47(2):178-83. doi: 10.4085/1062-6050-47.2.178.
PubMed 22488283
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Role of 905-nm Laser Light in the Delay of Muscle Fatigue
- ClinicalTrials.gov ID
- NCT03461731
- Acronym / sponsor ID
- IRB-2017-01-03-123913
- Conditions
- Muscle Fatigue
- Keywords
- Low-Level Light Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- College of CharlestonUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 12 Mar 2018 (actual)
- 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.
800-nm laser light has been shown to delay muscle fatigue when applied before exercise. The effect of illumination during the aerobic phase of strenuous exercise has not been studied. The investigators hypothesize that the increased energy donated to cells during the aerobic phase will significantly delay muscle fatigue. A novel aspect of this study is to include simultaneous treatment with near infrared light at 800 nm and 905 nm. Fatigue index and change in lactate blood level will be used to compare the different laser treatments for each participant. Monte Carlo simulations of light energy reaching the muscle will be carried out, based on skin-fold thickness measurements of each participant. The investigators believe this will be the first report of optical dosimetry as a function of adipose thickness and it will enable estimation how much of the light applied to the skin surface is able to penetrate to the muscles that are thought to be affected. The results of this study will help clinicians to optimize treatment for individual patients.
Detailed description
Rationale, Objectives and Significance A recent study has shown that low intensity Near Infrared (NIR) light at 810 nm applied before exercise results in an increase in performance and decrease in oxidative stress and muscle damage (1). Another study by the same group with 830 nm light showed a delay in exercise-induced muscle fatigue when applied before exercise (2). A number of studies have shown varying results with near infrared light for pain relief, inflammation and wound healing. The results often vary in part due to the difference in the wavelength and intensity of the light source and variation in the depth of penetration of the light. Red and NIR light is known to penetrate significantly into biological tissues. For example, a recent study presents qualitative evidence that 830 nm light penetrated significantly through cadaver soft tissue and a human hand in vivo (3). The optical properties of various human tissues have been studied at 800 to 950 nm so it is possible for the investigators to calculate the precise distribution of near infrared light in relation to the physiological effects. The investigators are well equipped to carry this out with an original, calibrated Monte Carlo program. The mechanism of action for low intensity red to NIR light has been fairly well studied and is thought to occur through absorption of the light by mitochondrial cytochrome c oxidase which leads to energy production in the illuminated cells (4). The effect of illumination DURING the aerobic phase of strenuous exercise has not been studied. The investigators hypothesize that the increased energy donated to cells during the aerobic phase will significantly delay muscle fatigue.
fatigue index and lactate blood level will be used to compare the different laser treatments. Another novel aspect of this study is to include NIR light at 905 nm. A hypothesized mechanism for delay of muscle fatigue is a light-initiated release of oxygen from hemoglobin molecules by 905-nm laser light, resulting in increased oxygenation of the local tissue. The laser may heat the tissue slightly so it is not clear whether oxygen release is due to a thermal or photochemical mechanism. A recent study of low level light (660 nm, 350 mW, 15 minutes) resulted in no measurable change in local tissue oxygenation for healthy participants (5). Another recent study with a more intense light source (K-laser at 800, 907 and 970 nm, 3 W, 4 minutes) demonstrated increased blood flow in the upper arm following irradiation with the NIR laser (6). However the authors did not measure the temperature of the irradiated tissue.
In the proposed study the investigators will keep the intensity of 800 nm light constant in all of the trials. The proposed study will include collection of surface temperature during the treatment to begin to document whether tissue heating is involved in the mechanism. The adipose thickness (calculated from skin fold thickness) will be used with the Monte Carlo simulation to calculate the fraction of light that is expected to reach the muscle for each participant. This will be the first report of optical dosimetry as a function of adipose thickness and it will enable estimation of how much of the light applied to the skin surface is able to penetrate to the muscles that are thought to be affected. The results of this study will help clinicians to optimize treatment for individual patients.
- Thiago de Marchi, Ernesto Cesar Pinto Leal Junior et al, Low level laser therapy (LLLT) in human progressive intensity running: effects on exercise performance, skeletal muscle status and oxidative stress. (2012) Lasers in Medical Science 27:231236.
- Ernesto Cesar Pinto Leal Junior, Rodrigo Alvaro Brandao LopexMartins et al. Effect of 830nm lowlevel therapy in exercise induced skeletal muscle fatigue in humans. (2009) Lasers in Medical Science 24:425431.
- Jared Jagdeo, Lauren Adams, et al. Transcranial red and near infrared light transmission in a cadaveric model. (2012) PLOS ONE 7:10 e47460
- Janis Eells, Margaret WongRiley, et al. Mitochondrial signal transduction in accelerated wound and retinal healing by near infrared light therapy. (2004) Mitochondrion Sep; 4(56):55967.
- Franziska Heu, Clemens Forster, Barbara Namer, Adrian Dragu, Werner Lang. Effect of lowlevel laser therapy on blood flow and oxygenhemoglobin saturation of the foot skin in healthy subjects: a pilot study. (2013) Laser Therapy 22(1): 2130.
- Kelly Larkin, Jeffrey Martin, Elizabeth Zeanah, Jerry Tue, Randy Braith, Paul Borsa. Limb blood flow after class 4 laser therapy. (2012) Journal of Athletic Training. 47(2): 178183.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Each participant receives placebo and two different light treatments in random order
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Device: ControlParticipant will receive a sham treatment that consists of just the 660-nm aiming beam |
| 800 nm laser | Experimental | Device: 800 nm laser800 nm laser will be applied at 4.4 Joules per square cm on the forearm during 40 repetitive hand grips |
| combination laser | Experimental | Device: combination laser905 nm and 800 nm will be applied at 4.4 joules per square cm with a total of 8.8 Joules per square cm during 40 repetitive handgrips. |
| 905 nm laser | Experimental | Device: 905 nm laser905 nm laser will be applied at 4.4 Joules per square cm on the forearm during 40 repetitive hand grips |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Between the ages of 18 and 25 years
Key exclusion criteria (4 listed)
- Upper extremity surgery
- Upper body musculoskeletal injury to the non-dominant arm within the past year
- Tattoos on the forearm
- Photosensitizing medications (listed on the consent form)
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 |
|---|---|---|
| Controllaser beam only | Device | Control |
| 800 nm laser800 nm laser applied to forearm at 4.4 Joules per square cm during 40 hand grips | Device | 800 nm laser |
| combination laser800 nm and 905 nm laser applied to forearm at 4.4 Joules per square cm during 40 hand grips | Device | combination laser |
| 905 nm laser905 nm laser applied to forearm at 4.4 Joules per square cm during 40 hand grips | Device | 905 nm laser |
Primary outcome
Muscle fatigue
Time frame: Muscle fatigue is calculated from force data immediately after each treatment.
Grip force measured by a dynamometer
1 secondary outcome
Lactate
Time frame: Lactate is measured immediately before each laser treatment and three minutes after each treatment.
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 12 Mar 2018.
- Background: PubMed 21739259De Marchi T, Leal Junior EC, Bortoli C, Tomazoni SS, Lopes-Martins RA, Salvador M. Low-level laser therapy (LLLT) in human progressive-intensity running: effects on exercise performance, skeletal muscle status, and oxidative stress. Lasers Med Sci. 2012 Jan;27(1):231-6. doi: 10.1007/s10103-011-0955-5. Epub 2011 Jul 8.
- 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 23077622Jagdeo JR, Adams LE, Brody NI, Siegel DM. Transcranial red and near infrared light transmission in a cadaveric model. PLoS One. 2012;7(10):e47460. doi: 10.1371/journal.pone.0047460. Epub 2012 Oct 15.
- Background: PubMed 16120414Eells JT, Wong-Riley MT, VerHoeve J, Henry M, Buchman EV, Kane MP, Gould LJ, Das R, Jett M, Hodgson BD, Margolis D, Whelan HT. Mitochondrial signal transduction in accelerated wound and retinal healing by near-infrared light therapy. Mitochondrion. 2004 Sep;4(5-6):559-67. doi: 10.1016/j.mito.2004.07.033.
- Background: PubMed 24155546Heu F, Forster C, Namer B, Dragu A, Lang W. Effect of low-level laser therapy on blood flow and oxygen- hemoglobin saturation of the foot skin in healthy subjects: a pilot study. Laser Ther. 2013;22(1):21-30. doi: 10.5978/islsm.13-or-03.
- Background: PubMed 22488283Larkin KA, Martin JS, Zeanah EH, True JM, Braith RW, Borsa PA. Limb blood flow after class 4 laser therapy. J Athl Train. 2012 Mar-Apr;47(2):178-83. doi: 10.4085/1062-6050-47.2.178.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after de-identification
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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.
Linda R Jones, Ph.D. principal investigator
College of Charleston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 800 nm laser, combination laser and 905 nm laser in people with Muscle Fatigue, run by College of Charleston at 1 site in United States.
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 1 inclusion and 4 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 12 Mar 2018. 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 United States. 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?
Muscle fatigue (time frame: Muscle fatigue is calculated from force data immediately after each treatment.). 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 NCT03461731, which also lists 6 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 12 Mar 2018.