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HealthyPhase 1NCT01610232

Infrared-LED During Physical Training for Rehabilitation, Physical Performance and Body Aesthetics

A Phase 1 study testing Photon stimulation by light-emitting diodes (LEDs) and Treadmill training in people with Healthy, run by University of Sao Paulo at 1 site in Brazil.

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

The investigators hypothesis is that the infrared-LED illumination during treadmill training can enhance physical performance in postmenopausal women. The basis for such a hypothesis is based on the fact that the light therapy during the intense metabolic stage caused by exercise may be more efficient. Read more about this study

Who is it for?
Ages 50 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Photon stimulation by light-emitting diodes (LEDs) and Treadmill training
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
Dec 2009to Dec 2010
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 50 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Postmenopausal women
  • Caucasian
  • 50 and 60 years of age
  • Healthy

Who cannot join

  • Neurological disease
  • Inflammatory disease
  • Pulmonary disease
  • Oncological disease
  • Cardiac disease
  • Endocrinopathy
Show all 9Show fewer
  • Musculotendinous or articular injuries
  • Hormone replacement therapy or osteoporosis drugs
  • Cigarette smoking

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Optics Group from Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

    São Carlos, São Paulo, 369

Other trials in Brazil

About this study

Official title: Effects of Infrared-LED Illumination Applied During Treadmill Training in Postmenopausal Women

The investigators hypothesis is that the infrared-LED illumination during treadmill training can enhance physical performance in postmenopausal women. The basis for such a hypothesis is based on the fact that the light therapy during the intense metabolic stage caused by exercise may be more efficient.

Read the detailed description

Phototherapy improves cellular activation via absorption of photons by chromophores present in the protein components of the mitochondrial respiratory chain - mainly NADH dehydrogenases and cytochrome C oxidase, which leads to increased electron transport, production of ATP, and tissue regeneration (skin, muscle, bone, and nerves). Moreover, phototherapy stimulates the anti-inflammatory effect with analgesia and vasodilatation. Regarding body aesthetics, phototherapy increases microcirculation, lymphatic drainage, as well as collagen synthesis for the treatment of cellulite. The objective of this study was to develop and evaluate the effects of a new clinical procedure: infrared radiation originated from LEDs associated with treadmill training in postmenopausal women. LED arrays were developed for an irradiation of a large area, such as hip and quadriceps muscles, main actuators during stance and swing phases. These body parts are furthermore areas where there is incidence of osteoporosis, mainly at the femur, localized fat deposits, and cellulite. Infrared radiation (850 nm) was selected because this spectral range shows better skin penetration compared to red interval.

Conditions
Healthy
Being tested
Photon stimulation by light-emitting diodes (LEDs), Treadmill training
Keywords
Infrared LED, Treadmill Training, Strength Muscle, Fatigue Muscle, Aerobic Capacity, Cellulite, Osteoporosis
Medical subject headings
Cellulite, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Photon stimulation by light-emitting diodes (LEDs)Device

    Treadmill training with the application of the phototherapy was performed twice a week for 6 months, each session lasting 45 min at intensities between 85% and 90% maximal heart rate. The average power and power density on the skin were 100 mW and 39 mW/cm2, respectively. The treatment time was 45 min bilaterally in both thighs. These parameters led to an approximate fluence of 108 J/cm2.

  • Treadmill trainingOther

    Treadmill training without the application of the phototherapy was performed twice a week for 6 months, each session lasting 45 min at intensities between 85% and 90% maximal heart rate

Study groups in NCT01610232
Study groupRoleWhat they receive
LED GroupExperimentalPhototherapy associated with treadmill training
Receives: Device: Photon stimulation by light-emitting diodes (LEDs)
Exercise GroupActive comparatorTreadmill training
Receives: Other: Treadmill training
Sedentary GroupNo interventionNeither physical training nor phototherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effects of Infrared-LED Illumination Associated with Treadmill Training

    Quantitative and qualitative evaluations

    Measured: 12 months

Secondary outcomes (8)

  1. Maximal exercise testing

    Progressive aerobic exercise testing on treadmill (Modified Bruce Protocol)

    Measured: Baseline and 6 months

  2. Isokinetic concentric exercise testing

    Peak torque, power, work, and fatigue of the dominant quadriceps were measured using the isokinetic dynamometer

    Measured: Baseline, 6 months and 12 months

  3. Biochemical tests

    Thyroid stimulating hormone (TSH), urea, creatinine, triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol, insulin and glucose

    Measured: Baseline and 6 months

  4. Quality of life

    Menopause Rating Scale (MRS) and Women´s Health Questionnaire (WHQ)

    Measured: Baseline and 6 months

  5. Dietary habits

    3-day dietary record

    Measured: Baseline and 6 months

  6. Exercise tolerance and heart rate variability

    Submaximal constant-speed testing and heart rate variability via autonomic reflex testing

    Measured: Baseline and 6 months

  7. Bone mineral density

    Bone mineral density (femoral neck, wrist, and lumbar spine) via dual-energy x-ray absorptiometry (DXA)

    Measured: Baseline and 12 months

  8. Thermography

    Cutaneous temperature measurements

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2012 (estimated)
  2. Study startDec 2009
  3. Primary completionDec 2010
  4. Study completionDec 2010

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01610232
Sponsor's protocol ID
98142708
Status last verified
May 2012
First submitted
30 May 2012
Last updated
1 Jun 2012
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 21086010

  • Vieira WH, Ferraresi C, Perez SE, Baldissera V, Parizotto NA. Effects of low-level laser therapy (808 nm) on isokinetic muscle performance of young women submitted to endurance training: a randomized controlled clinical trial. Lasers Med Sci. 2012 Mar;27(2):497-504. doi: 10.1007/s10103-011-0984-0. Epub 2011 Aug 26.

    PubMed 21870127

  • 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

  • Baroni 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 20626264

  • Leal Junior EC, Lopes-Martins RA, Baroni BM, De Marchi T, Rossi RP, Grosselli D, Generosi RA, de Godoi V, Basso M, Mancalossi JL, Bjordal JM. Comparison between single-diode low-level laser therapy (LLLT) and LED multi-diode (cluster) therapy (LEDT) applications before high-intensity exercise. Photomed Laser Surg. 2009 Aug;27(4):617-23. doi: 10.1089/pho.2008.2350.

    PubMed 19302015

  • Karu TI, Pyatibrat LV, Afanasyeva NI. Cellular effects of low power laser therapy can be mediated by nitric oxide. Lasers Surg Med. 2005 Apr;36(4):307-14. doi: 10.1002/lsm.20148.

    PubMed 15739174

  • Corazza AV, Jorge J, Kurachi C, Bagnato VS. Photobiomodulation on the angiogenesis of skin wounds in rats using different light sources. Photomed Laser Surg. 2007 Apr;25(2):102-6. doi: 10.1089/pho.2006.2011.

    PubMed 17508845

  • Whelan HT, Smits RL Jr, Buchman EV, Whelan NT, Turner SG, Margolis DA, Cevenini V, Stinson H, Ignatius R, Martin T, Cwiklinski J, Philippi AF, Graf WR, Hodgson B, Gould L, Kane M, Chen G, Caviness J. Effect of NASA light-emitting diode irradiation on wound healing. J Clin Laser Med Surg. 2001 Dec;19(6):305-14. doi: 10.1089/104454701753342758.

    PubMed 11776448

  • Vladimirov YA, Osipov AN, Klebanov GI. Photobiological principles of therapeutic applications of laser radiation. Biochemistry (Mosc). 2004 Jan;69(1):81-90. doi: 10.1023/b:biry.0000016356.93968.7e.

    PubMed 14972023

  • Paolillo FR, Milan JC, Aniceto IV, Barreto SG, Rebelatto JR, Borghi-Silva A, Parizotto NA, Kurachi C, Bagnato VS. Effects of infrared-LED illumination applied during high-intensity treadmill training in postmenopausal women. Photomed Laser Surg. 2011 Sep;29(9):639-45. doi: 10.1089/pho.2010.2961. Epub 2011 Jul 12.

    PubMed 21749263

  • Paolillo FR, Borghi-Silva A, Parizotto NA, Kurachi C, Bagnato VS. New treatment of cellulite with infrared-LED illumination applied during high-intensity treadmill training. J Cosmet Laser Ther. 2011 Aug;13(4):166-71. doi: 10.3109/14764172.2011.594065.

    PubMed 21740089

  • Paolillo FR, Corazza AV, Borghi-Silva A, Parizotto NA, Kurachi C, Bagnato VS. Infrared LED irradiation applied during high-intensity treadmill training improves maximal exercise tolerance in postmenopausal women: a 6-month longitudinal study. Lasers Med Sci. 2013 Feb;28(2):415-22. doi: 10.1007/s10103-012-1062-y. Epub 2012 Mar 2.

    PubMed 22382875

  • Paolillo FR, Milan JC, Bueno Pde G, Paolillo AR, Borghi-Silva A, Parizotto NA, Arena R, Kurachi C, Bagnato VS. Effects of excess body mass on strength and fatigability of quadriceps in postmenopausal women. Menopause. 2012 May;19(5):556-61. doi: 10.1097/gme.0b013e3182364e80.

    PubMed 22089183

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Photon stimulation by light-emitting diodes (LEDs) and Treadmill training in people with Healthy, run by University of Sao Paulo 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 9 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 1 Jun 2012. 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?

Effects of Infrared-LED Illumination Associated with Treadmill Training (time frame: 12 months). 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 NCT01610232, which also lists 13 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 1 Jun 2012.

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