Diabetic NeuropathiesNCT03369834
Light-emitting-diode in Diabetic Subjects
A study testing Red Light-emitting diode device, Infrared Light-emitting diode device and Infrared and Red Light-emitting diode device in people with Diabetic Neuropathies, run by Rinaldo Roberto de Jesus Guirro at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Red Light-emitting diode device, Infrared Light-emitting diode device and Infrared and Red Light-emitting diode device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2018to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of Light-emitting Diode-phototherapy on Strength, Functional Performance and Blood Flow in Diabetic Subjects
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.
Read the 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.
- Conditions
- Diabetic Neuropathies
- Being tested
- Red Light-emitting diode device, Infrared Light-emitting diode device, Infrared and Red Light-emitting diode device, Sham
- Keywords
- phototherapy, diabetes mellitus, exercise
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Light-emitting diode deviceDevice
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.
Infrared Light-emitting diode deviceDevice
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.
Infrared and Red Light-emitting diode deviceDevice
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.
ShamDevice
LED device off.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | the volunteers of this group will not be submitted to the intervention. |
| Red LED group | Experimental | 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. Receives: Device: Red Light-emitting diode device |
| LED group infrared | Active comparator | 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. Receives: Device: Infrared Light-emitting diode device |
| LED group mixed | Active comparator | 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. Receives: Device: Infrared and Red Light-emitting diode device |
| Sham Group | Placebo comparator | LED device off. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
strength capacities
N/m
Measured: Twenty minutes
Secondary outcomes (4)
Electromyography
Muscle recruitment - Hertz
Measured: Twenty minutes
Time up and Go
time
Measured: two minutes
6-minute walk test
meters
Measured: ten minutes
blood flow
mL/s
Measured: ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start1 Feb 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rinaldo Roberto de Jesus Guirro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
- Investigators
- Rinaldo RJ Guirro, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369834
- Sponsor's protocol ID
- U1111-1143-3534
- Status last verified
- Mar 2020
- First submitted
- 30 Nov 2017
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27250715
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Light-emitting Diode-phototherapy on Strength, Functional Performance and Blood Flow in Diabetic Subjects
- ClinicalTrials.gov ID
- NCT03369834
- Acronym / sponsor ID
- U1111-1143-3534
- Conditions
- Diabetic Neuropathies
- Keywords
- phototherapy, diabetes mellitus, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Rinaldo Roberto de Jesus GuirroUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
- 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)
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –the volunteers of this group will not be submitted to the intervention. |
| Red LED group | Experimental | Device: Red Light-emitting diode devicein 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. |
| LED group infrared | Active comparator | Device: Infrared Light-emitting diode devicein 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. |
| LED group mixed | Active comparator | Device: Infrared and Red Light-emitting diode devicein 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. |
| Sham Group | Placebo comparator | Device: ShamLED device off. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Light-emitting diode deviceThe 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. | Device | Red LED group |
| Infrared Light-emitting diode deviceThe 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. | Device | LED group infrared |
| Infrared and Red Light-emitting diode deviceThe 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. | Device | LED group mixed |
| ShamLED device off. | Device | Sham Group |
Primary outcome
strength capacities
Time frame: Twenty minutes
N/m
4 secondary outcomes
Electromyography
Time frame: Twenty minutes
Time up and Go
Time frame: two minutes
6-minute walk test
Time frame: ten minutes
blood flow
Time frame: ten minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Results publication: PubMed 27250715Toma 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.
- access platformLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rinaldo RJ Guirro, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Light-emitting diode device, Infrared Light-emitting diode device and Infrared and Red Light-emitting diode device in people with Diabetic Neuropathies, run by Rinaldo Roberto de Jesus Guirro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
strength capacities (time frame: Twenty minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03369834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.