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

NCT01610232 | Completed Phase 1 DMC

• 1 other identifier: 98142708
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Infrared LED; Treadmill Training; Strength Muscle; Fatigue Muscle; Aerobic Capacity; Cellulite; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Effects of Infrared-LED Illumination Associated with Treadmill Training

  Quantitative and qualitative evaluations

  12 months

Secondary Outcomes (8)

• Maximal exercise testing

  Baseline and 6 months

• Isokinetic concentric exercise testing

  Baseline, 6 months and 12 months

• Biochemical tests

  Baseline and 6 months

• Quality of life

  Baseline and 6 months

• Dietary habits

  Baseline and 6 months

Study Arms (3)

LED Group

EXPERIMENTAL

Phototherapy associated with treadmill training

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

Exercise Group

ACTIVE COMPARATOR

Treadmill training

Other: Treadmill training

Sedentary Group

NO INTERVENTION

Neither physical training nor phototherapy

Interventions

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.

LED Group

Treadmill training 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

Exercise Group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

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

São Carlos, São Paulo, 369, Brazil

Location

Related Publications (13)

• 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.

  PMID: 21086010 BACKGROUND

• 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.

  PMID: 21870127 BACKGROUND

• 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.

  PMID: 21739259 BACKGROUND

• 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.

  PMID: 20626264 BACKGROUND

• 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.

  PMID: 19302015 BACKGROUND

• 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.

  PMID: 15739174 BACKGROUND

• 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.

  PMID: 17508845 BACKGROUND

• 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.

  PMID: 11776448 BACKGROUND

• 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.

  PMID: 14972023 BACKGROUND

• 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.

  PMID: 21749263 RESULT

• 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.

  PMID: 21740089 RESULT

• 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.

  PMID: 22382875 RESULT

• 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.

  PMID: 22089183 RESULT

Related Links

• Research: Biophotonics (phototherapy)

MeSH Terms

Conditions

Cellulite; Osteoporosis

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Vanderlei S Bagnato, Ph.D

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

  STUDY DIRECTOR

• Cristina Kurachi, Ph.D

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

  STUDY DIRECTOR

• Fernanda R Paolillo, Ph.D

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 1, 2012
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

BR (1)