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Completed

NCT Number: NCT01610232

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

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.

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Key information

Conditions

Healthy Bone Diseases Bone Diseases, Metabolic Cellulite Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

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

São Carlos, São Paulo, 369, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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

Primary outcomes

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

    Time frame: 12 months

    Quantitative and qualitative evaluations

Secondary outcomes

  1. Maximal exercise testing

    Time frame: Baseline and 6 months

    Progressive aerobic exercise testing on treadmill (Modified Bruce Protocol)

  2. 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

  3. 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

  4. Quality of life

    Time frame: Baseline and 6 months

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

  5. Dietary habits

    Time frame: Baseline and 6 months

    3-day dietary record

  6. Exercise tolerance and heart rate variability

    Time frame: Baseline and 6 months

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

  7. 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)

  8. Thermography

    Time frame: Baseline

    Cutaneous temperature measurements

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 1, 2012
Registry last updated
Jun 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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