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Light-emitting-diode in Diabetic Subjects

Primary Purpose

Diabetic Neuropathies

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Red Light-emitting diode device
Infrared Light-emitting diode device
Infrared and Red Light-emitting diode device
Sham
Sponsored by
Rinaldo Roberto de Jesus Guirro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies focused on measuring phototherapy, diabetes mellitus, exercise

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Control Group

Red LED group

LED group infrared

LED group mixed

Sham Group

Arm Description

the volunteers of this group will not be submitted to the intervention.

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.

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.

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.

LED device off.

Outcomes

Primary Outcome Measures

strength capacities
N/m

Secondary Outcome Measures

Electromyography
Muscle recruitment - Hertz
Time up and Go
time
6-minute walk test
meters
blood flow
mL/s

Full Information

First Posted
November 30, 2017
Last Updated
March 11, 2020
Sponsor
Rinaldo Roberto de Jesus Guirro
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1. Study Identification

Unique Protocol Identification Number
NCT03369834
Brief Title
Light-emitting-diode in Diabetic Subjects
Official Title
Acute Effect of Light-emitting Diode-phototherapy on Strength, Functional Performance and Blood Flow in Diabetic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rinaldo Roberto de Jesus Guirro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
Keywords
phototherapy, diabetes mellitus, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
the volunteers of this group will not be submitted to the intervention.
Arm Title
Red LED group
Arm Type
Experimental
Arm Description
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.
Arm Title
LED group infrared
Arm Type
Active Comparator
Arm Description
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.
Arm Title
LED group mixed
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham Group
Arm Type
Placebo Comparator
Arm Description
LED device off.
Intervention Type
Device
Intervention Name(s)
Red Light-emitting diode device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Infrared Light-emitting diode device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Infrared and Red Light-emitting diode device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
LED device off.
Primary Outcome Measure Information:
Title
strength capacities
Description
N/m
Time Frame
Twenty minutes
Secondary Outcome Measure Information:
Title
Electromyography
Description
Muscle recruitment - Hertz
Time Frame
Twenty minutes
Title
Time up and Go
Description
time
Time Frame
two minutes
Title
6-minute walk test
Description
meters
Time Frame
ten minutes
Title
blood flow
Description
mL/s
Time Frame
ten minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rinaldo RJ Guirro, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
University of São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27250715
Citation
Toma RL, Vassao PG, Assis L, Antunes HK, Renno AC. Low level laser therapy associated with a strength training program on muscle performance in elderly women: a randomized double blind control study. Lasers Med Sci. 2016 Aug;31(6):1219-29. doi: 10.1007/s10103-016-1967-y. Epub 2016 Jun 1.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=Low+level+laser+therapy+associated+with+a+strength+training+program+on+muscle+performance+in+elderly+women%3A+a+randomized+double+blind+control+study.
Description
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Light-emitting-diode in Diabetic Subjects

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