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

May 31, 2012 updated by: Fernanda Rossi Paolillo, University of Sao Paulo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Carlos, São Paulo, Brazil, 369
        • Optics Group from Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Infrared-LED Illumination Associated with Treadmill Training
Time Frame: 12 months
Quantitative and qualitative evaluations
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal exercise testing
Time Frame: Baseline and 6 months
Progressive aerobic exercise testing on treadmill (Modified Bruce Protocol)
Baseline and 6 months
Isokinetic concentric exercise testing
Time Frame: Baseline, 6 months and 12 months
Peak torque, power, work, and fatigue of the dominant quadriceps were measured using the isokinetic dynamometer
Baseline, 6 months and 12 months
Biochemical tests
Time Frame: Baseline and 6 months
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
Baseline and 6 months
Quality of life
Time Frame: Baseline and 6 months
Menopause Rating Scale (MRS) and Women´s Health Questionnaire (WHQ)
Baseline and 6 months
Dietary habits
Time Frame: Baseline and 6 months
3-day dietary record
Baseline and 6 months
Exercise tolerance and heart rate variability
Time Frame: Baseline and 6 months
Submaximal constant-speed testing and heart rate variability via autonomic reflex testing
Baseline and 6 months
Bone mineral density
Time Frame: Baseline and 12 months
Bone mineral density (femoral neck, wrist, and lumbar spine) via dual-energy x-ray absorptiometry (DXA)
Baseline and 12 months
Thermography
Time Frame: Baseline
Cutaneous temperature measurements
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (ESTIMATE)

June 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 1, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 98142708

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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