- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03461731
Investigation of the Role of 905-nm Laser Light in the Delay of Muscle Fatigue
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29424
- College of Charleston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Between the ages of 18 and 25 years
Exclusion Criteria
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Control
Participant will receive a sham treatment that consists of just the 660-nm aiming beam
|
laser beam only
|
|
Experimental: 800 nm laser
800 nm laser will be applied at 4.4 Joules per square cm on the forearm during 40 repetitive hand grips
|
800 nm laser applied to forearm at 4.4 Joules per square cm during 40 hand grips
|
|
Experimental: combination laser
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.
|
800 nm and 905 nm laser applied to forearm at 4.4 Joules per square cm during 40 hand grips
|
|
Experimental: 905 nm laser
905 nm laser will be applied at 4.4 Joules per square cm on the forearm during 40 repetitive hand grips
|
905 nm laser applied to forearm at 4.4 Joules per square cm during 40 hand grips
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle fatigue
Time Frame: Muscle fatigue is calculated from force data immediately after each treatment.
|
Grip force measured by a dynamometer
|
Muscle fatigue is calculated from force data immediately after each treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lactate
Time Frame: Lactate is measured immediately before each laser treatment and three minutes after each treatment.
|
Change in blood lactate level
|
Lactate is measured immediately before each laser treatment and three minutes after each treatment.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Linda R Jones, Ph.D., College of Charleston
Publications and helpful links
General Publications
- Eells 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.
- 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.
- Leal 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.
- Jagdeo 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.
- Heu 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.
- Larkin 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2017-01-03-123913
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Muscle Fatigue
-
University of TorontoCompleted
-
University of British ColumbiaCompletedMuscle Fatigue | Muscle PowerCanada
-
Karabuk UniversityNot yet recruitingMuscle Fatigue and Muscle Oxygenation
-
Akdeniz UniversityCompletedExercise-Induced Fatigue | Forearm Muscle FatigueTurkey (Türkiye)
-
University of Nove de JulhoFundação de Amparo à Pesquisa do Estado de São PauloCompletedMuscle; Fatigue, Heart | Skeletal Muscle RecoveryBrazil
-
University of Nove de JulhoFundação de Amparo à Pesquisa do Estado de São PauloCompletedMuscle; Fatigue, Heart | Skeletal Muscle RecoveryBrazil
-
University of BeykentCompletedAthletic Performance | Muscle Fatigue | Muscle ElasticityTurkey (Türkiye)
-
Metabolic Technologies Inc.University of TampaCompletedMuscle Fatigue Caused by Repetitive Muscle ExerciseUnited States
-
University of British ColumbiaNot yet recruitingAgeing | Muscle Fatigue Caused by Repetitive Muscle ExerciseCanada
-
Universidade Federal de Sao CarlosRecruitingAthletic Performance | Muscle Strength | Muscle Fatigue | SportsBrazil
Clinical Trials on Control
-
Vanderbilt University Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)Enrolling by invitationCritical Illness | Respiratory Failure | Mechanical VentilationUnited States
-
Claudia M. WittCompleted
-
University of California, San FranciscoWithdrawn
-
The George InstituteChanghai Hospital; University of CalgaryRecruitingIschemic Stroke, AcuteCanada, Australia
-
Universidad Nacional de Educación a DistanciaMinisterio de Economía y Competitividad, SpainUnknownChronic Pain | FibromyalgiaSpain
-
University of California, Los AngelesThe National Council on Aging; City of Los Angeles Department of Aging; Los Angeles...Completed
-
Takeshi MorimotoUniversity of the RyukyusCompletedCoronary Artery Disease | Hypertension | Type 2 Diabetes | DyslipidemiaJapan
-
Queen's University, BelfastPublic Health Agency, Health and Social Care Research and Development; Tiny...Completed
-
Johnson & Johnson Vision Care, Inc.TerminatedRefractive Error CorrectionUnited States
-
Yonsei UniversityRecruitingHypertension | Chronic Kidney Diseases | DyslipidemiasKorea, Republic of