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Light-emitting-diode in Diabetic Subjects

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ClinicalTrials.gov Identifier: NCT03369834
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Rinaldo Roberto de Jesus Guirro, University of Sao Paulo

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Device: Red Light-emitting diode device Device: Infrared Light-emitting diode device Device: Infrared and Red Light-emitting diode device Device: Sham Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
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
Official Title: Acute Effect of Light-emitting Diode-phototherapy on Strength, Functional Performance and Blood Flow in Diabetic Subjects
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control Group
the volunteers of this group will not be submitted to the intervention.
Experimental: Red LED group
in the volunteers of this group will be applied Red Light-emitting diode device with the length 620nm wave along the entire tibialis anterior muscle and bilateral sural triceps.
 Device: Red Light-emitting diode device

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.
Active Comparator: LED group infrared
in the volunteers of this group will be applied Infrared Light-emitting diode device with the wavelength of 940nm throughout the tibialis anterior muscle and bilateral sural triceps.
 Device: Infrared Light-emitting diode device

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.
Active Comparator: LED group mixed
in the volunteers of this group will be applied Infrared and Red Light-emitting diode device with the wavelength of 940nm and 620nm throughout the tibialis anterior muscle and bilateral sural triceps.
 Device: Infrared and Red Light-emitting diode device

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.
Placebo Comparator: Sham Group
LED device off.
 Device: Sham
LED device off.


Outcome Measures
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Primary Outcome Measures :
  1. strength capacities [ Time Frame: Twenty minutes ]
    N/m


Secondary Outcome Measures :
  1. Electromyography [ Time Frame: Twenty minutes ]
    Muscle recruitment - Hertz

  2. Time up and Go [ Time Frame: two minutes ]
    time

  3. 6-minute walk test [ Time Frame: ten minutes ]
    meters

  4. blood flow [ Time Frame: ten minutes ]
    mL/s


Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sedentary and insufficiently active individuals with the the International Physical Activity Questionnaire (IPAQ) .
  • Both sexes
  • Age range of 45 to 70 years
  • Diagnostic Scale for Diabetic Distal Polyneuropathy - Score 3 or more

Exclusion Criteria:

  • Present musculoskeletal or neurological lesions that make it impossible to perform the functional and strength tests.
  • Negative result for the tactile sensitivity test with the monofilament.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369834


Locations
Layout table for location information
Brazil
University of São Paulo
Ribeirão Preto, São Paulo, Brazil, 14049-900
Sponsors and Collaborators
Rinaldo Roberto de Jesus Guirro
Investigators
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Study Director: Rinaldo RJ Guirro, PhD University of São Paulo
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Rinaldo Roberto de Jesus Guirro, Clinical Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03369834    
Other Study ID Numbers: U1111-1143-3534
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rinaldo Roberto de Jesus Guirro, University of Sao Paulo:
phototherapy
diabetes mellitus
exercise
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases