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

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: Photon stimulation by light-emitting diodes (LEDs)
* Other: Treadmill training


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LED Group<br>Phototherapy associated with treadmill training | Device: Photon stimulation by light-emitting diodes (LEDs)<br>* 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.<br>|
| Active Comparator: Exercise Group<br>Treadmill training | Other: Treadmill training<br>* 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<br>|
| No Intervention: Sedentary Group<br>Neither physical training nor phototherapy | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infrared LED, Treadmill Training, Strength Muscle, Fatigue Muscle, Aerobic Capacity, Cellulite, Osteoporosis