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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

  1. 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.
  2. 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.
  3. Jared Jagdeo, Lauren Adams, et al. Transcranial red and near infrared light transmission in a cadaveric model. (2012) PLOS ONE 7:10 e47460
  4. 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.
  5. 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.
  6. 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 groups in NCT03461731
Study groupRoleWhat they receive
ControlSham comparatorParticipant will receive a sham treatment that consists of just the 660-nm aiming beam
Receives: Device: Control
800 nm laserExperimental800 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 laserExperimental905 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 laserExperimental905 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.

  1. Muscle fatigue

    Grip force measured by a dynamometer

    Measured: Muscle fatigue is calculated from force data immediately after each treatment.

Secondary outcomes (1)
  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.

  1. First posted12 Mar 2018
  2. Study start20 Feb 2017
  3. Primary completion30 Jul 2017
  4. Study completion31 Jul 2017

Resources

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)
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 21739259
  • 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.

    PubMed 18649044
  • 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.

    PubMed 23077622
  • 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.

    PubMed 16120414
  • 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.

    PubMed 24155546
  • 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.

    PubMed 22488283

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.

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