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

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Fernanda Rossi Paolillo, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01610232
First received: May 30, 2012
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Device: Photon stimulation by light-emitting diodes (LEDs)
Other: Treadmill training
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Infrared-LED Illumination Applied During Treadmill Training in Postmenopausal Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Effects of Infrared-LED Illumination Associated with Treadmill Training [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Quantitative and qualitative evaluations


Secondary Outcome Measures:
  • Maximal exercise testing [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
    Progressive aerobic exercise testing on treadmill (Modified Bruce Protocol)

  • Isokinetic concentric exercise testing [ Time Frame: Baseline, 6 months and 12 months ] [ Designated as safety issue: Yes ]
    Peak torque, power, work, and fatigue of the dominant quadriceps were measured using the isokinetic dynamometer

  • Biochemical tests [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
    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

  • Quality of life [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
    Menopause Rating Scale (MRS) and Women´s Health Questionnaire (WHQ)

  • Dietary habits [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
    3-day dietary record

  • Exercise tolerance and heart rate variability [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
    Submaximal constant-speed testing and heart rate variability via autonomic reflex testing

  • Bone mineral density [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]
    Bone mineral density (femoral neck, wrist, and lumbar spine) via dual-energy x-ray absorptiometry (DXA)

  • Thermography [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Cutaneous temperature measurements


Enrollment: 45
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LED Group
Phototherapy associated with treadmill training
 Device: 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.
Active Comparator: Exercise Group
Treadmill training
 Other: 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
No Intervention: Sedentary Group
Neither physical training nor phototherapy

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.

  Eligibility

Ages Eligible for Study:   50 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610232

Locations
Brazil
Optics Group from Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
São Carlos, São Paulo, Brazil, 369
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Study Director: 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)
Principal Investigator: Fernanda R Paolillo, Ph.D Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
  More Information

Additional Information:
Research: Biophotonics (phototherapy)  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Fernanda Rossi Paolillo, Ph.D, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01610232     History of Changes
Other Study ID Numbers: 98142708
Study First Received: May 30, 2012
Last Updated: May 31, 2012
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo:
Infrared LED
Treadmill Training
Strength Muscle
Fatigue Muscle
 Aerobic Capacity
Cellulite
Osteoporosis

ClinicalTrials.gov processed this record on May 23, 2013