Light-emitting-diode in Diabetic Subjects
Condition: Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies
Study type: Interventional

Summary: 
      Diabetes mellitus (DM) is a metabolic disorder, characterized by hyperglycemia and metabolic
      disorders, resulting in changes in insulin secretion and / or action. Physical function is
      critical for functional independence, and chronic diseases such as diabetes can lead to
      functional decline, and diabetes mellitus is a major contributor to the progression of
      sarcopenia and physical disability. DM is also known to have a strong associated with the
      development of peripheral arterial disease. Peripheral arterial disease is characterized by
      obstruction of the arteries of the lower limbs, leading to a low oxygenation of the muscles
      of the lower extremities. Among the physiotherapeutic resources that can be used,
      phototherapy involves the use of light for the treatment of muscular injuries, by modulating
      the physiological processes associated with the repair process. Clinical trials show that
      light emitting diode (LED) is a technique that interferes with muscle strength, generating an
      increase in maximal voluntary contraction and peak torque. It is hypothesized that the LED
      application is capable of improving the muscular strength, fatigue, functional performance
      and blood flow capabilities in individuals with diabetes. It is also expected that the
      results of this study may contribute to and increase the resources used by physiotherapists
      within the clinical scope, contributing to the care of diabetic patients.
    

Detailed description: 
      Diabetes mellitus (DM) is a metabolic disorder, characterized by hyperglycemia and metabolic
      disorders, resulting in changes in insulin secretion and / or action. Physical function is
      critical for functional independence, and chronic diseases such as diabetes can lead to
      functional decline, and diabetes mellitus is a major contributor to the progression of
      sarcopenia and physical disability. DM is also known to have a strong associated with the
      development of peripheral arterial disease. Peripheral arterial disease is characterized by
      obstruction of the arteries of the lower limbs, leading to a low oxygenation of the muscles
      of the lower extremities. Among the physiotherapeutic resources that can be used,
      phototherapy involves the use of light for the treatment of muscular injuries, by modulating
      the physiological processes associated with the repair process. Clinical trials show that LED
      is a technique that interferes with muscle strength, generating an increase in maximal
      voluntary contraction and peak torque. It is hypothesized that the LED application is capable
      of improving the muscular strength, fatigue, functional performance and blood flow
      capabilities in individuals with diabetes. It is also expected that the results of this study
      may contribute to and increase the resources used by physiotherapists within the clinical
      scope, contributing to the care of diabetic patients. A randomized and blinded clinical trial
      will be carried out at the Physiotherapeutic Resources Laboratory (LARF) of the University of
      São Paulo Medical School of Ribeirão Preto (FMRP-USP). The study procedures will be performed
      in 5 days. On the first day (pre-treatment), the volunteers will be evaluated for
      functionality (Time Up and Go), cardiopulmonary capacity (6-minute walk test), evaluation of
      muscle function (isokinetic dynamometer), neuromuscular recruitment (electromyography)
      gastrocnemius and evaluation of blood flow (Doppler) of the tibial and popliteal arteries. On
      the second, third and fourth day volunteers of GLED-V, GLED-IV, GM e GP will return to the
      application of LED intervention according to the group in which they are allocated. On the
      fifth day (reevaluation) the volunteers will perform the same tests of the first day.
    

Intervention name(s): Red Light-emitting diode device; Infrared Light-emitting diode device; Infrared and Red Light-emitting diode device; Sham
Intervention type(s): Device; Device; Device; Device
Intervention description(s): The phototherapy will be applied for 3 days followed by a red LED blanket of 25x40 cm2, with equidistant distribution - 1 cm between them, with total energy per area of 180 J, bilaterally on the anterior tibial and triceps sural muscles, bilaterally. The intervention of these muscular groups is made possible by the distal involvement of diabetic polyneuropathy.
All LEDs will be checked at the beginning of the project in the Laboratory of Photophysics of the Faculty of Philosophy, Sciences and Letters of Ribeirão Preto, University of São Paulo, in which the wavelengths will be checked, the angle of radiation, power and power density.; The phototherapy will be applied for 3 days followed by a infrared LED blanket of 25x40 cm2, with equidistant distribution - 1 cm between them, with total energy per area of 180 J, bilaterally on the anterior tibial and triceps sural muscles, bilaterally. The intervention of these muscular groups is made possible by the distal involvement of diabetic polyneuropathy.
All LEDs will be checked at the beginning of the project in the Laboratory of Photophysics of the Faculty of Philosophy, Sciences and Letters of Ribeirão Preto, University of São Paulo, in which the wavelengths will be checked, the angle of radiation, power and power density.; The phototherapy will be applied for 3 days followed by a infrared and Red LED blanket of 25x40 cm2, with equidistant distribution - 1 cm between them, with total energy per area of 180 J, bilaterally on the anterior tibial and triceps sural muscles, bilaterally. The intervention of these muscular groups is made possible by the distal involvement of diabetic polyneuropathy.
All LEDs will be checked at the beginning of the project in the Laboratory of Photophysics of the Faculty of Philosophy, Sciences and Letters of Ribeirão Preto, University of São Paulo, in which the wavelengths will be checked, the angle of radiation, power and power density.; LED device off.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Control Group (GC=13) LED red group (GLED-V = 13) Infrared LED Group (GLED-IV = 13) Mixed Group (GM = 13) Sham Group (GP = 13)
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: phototherapy; diabetes mellitus; exercise