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

NCT ID: NCT01610232

Last Updated: 2012-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LED Group

Phototherapy associated with treadmill training

Group Type EXPERIMENTAL

Photon stimulation by light-emitting diodes (LEDs)

Intervention Type 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.

Exercise Group

Treadmill training

Group Type ACTIVE_COMPARATOR

Treadmill training

Intervention Type OTHER

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

Sedentary Group

Neither physical training nor phototherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Photon stimulation by light-emitting diodes (LEDs)

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.

Intervention Type DEVICE

Treadmill training

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Neurological disease
* Inflammatory disease
* Pulmonary disease
* Oncological disease
* Cardiac disease
* Endocrinopathy
* Musculotendinous or articular injuries
* Hormone replacement therapy or osteoporosis drugs
* Cigarette smoking
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Fernanda Rossi Paolillo

Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vanderlei S Bagnato, Ph.D

Role: STUDY_DIRECTOR

Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

Cristina Kurachi, Ph.D

Role: STUDY_DIRECTOR

Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

Fernanda R Paolillo, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

Locations

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

São Carlos, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 21086010 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21870127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21739259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20626264 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19302015 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15739174 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17508845 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11776448 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14972023 (View on PubMed)

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.

Reference Type RESULT
PMID: 21749263 (View on PubMed)

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.

Reference Type RESULT
PMID: 21740089 (View on PubMed)

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.

Reference Type RESULT
PMID: 22382875 (View on PubMed)

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.

Reference Type RESULT
PMID: 22089183 (View on PubMed)

Related Links

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http://cepof.ifsc.usp.br/

Research: Biophotonics (phototherapy)

Other Identifiers

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98142708

Identifier Type: -

Identifier Source: org_study_id

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