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Acute Effect of Phototherapy With Light Emitting Diode (LED) on Muscle and Pulmonary Oxygen Consumption on Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Phototherapy through light emitting diode (LED) - 150J
Placebo phototherapy - 150J
Phototherapy through light emitting diode (LED) - 300J
Placebo phototherapy - 300J
Sponsored by
Aparecida Maria Catai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes mellitus, type 2, phototherapy, physical exercise, oxygen consumption, arterial blood pressure, heart rate, baroreflex sensitivity, cardiovascular autonomic control

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • overt coronary disease
  • sedentary
  • Clinical diagnosis of diabetes mellitus
  • Free of diabetes mellitus to participate of control group

Exclusion Criteria:

  • autonomic neuropathy
  • Smoking
  • anemia
  • alcoholism
  • disability conditions precluding exercise

Sites / Locations

  • Universidade Federal de São CarlosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Individuals with diabetes mellitus (phototherapy 150J)

Health individuals - 150J (phototherapy 150J)

Individuals with diabetes mellitus (phototherapy 300J)

Health individuals (phototherapy 300J)

Arm Description

The intervention of this study is phototherapy through light emitting diode (LED) and dose of 150J each muscle. The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surae muscles bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy.

The intervention of this study is phototherapy through light emitting diode (LED) and dose of 150J each muscle. The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surae muscle bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy.

The intervention of this study is phototherapy through light emitting diode (LED) with 300J. The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surale muscles bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy.

The intervention of this study is phototherapy through light emitting diode (LED). The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surae muscle bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy.

Outcomes

Primary Outcome Measures

Change in muscle oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in muscle oxygen uptake evaluated through near-infrared spectroscopy (NIRS) (Oxymon system, Artinis Medical Systems, Netherlands). The optode of NIRS will be fixed on quadriceps muscle in the right side.
Change in muscle oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in muscle oxygen uptake evaluated through near-infrared spectroscopy (NIRS) (Oxymon system, Artinis Medical Systems, Netherlands). The optode of NIRS will be fixed on quadriceps muscle in the right side.

Secondary Outcome Measures

Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
20 men with diabetes mellitus and 20 health men will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in pulmonary oxygen uptake evaluated through metabolic unit (CPX/D, MedGraphics, St. Paul, Minnesota, USA) continuously collected breath-by-breath.
Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
20 men with diabetes mellitus and 20 health men will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in pulmonary oxygen uptake evaluated through metabolic unit (CPX/D, MedGraphics, St. Paul, Minnesota, USA) continuously collected breath-by-breath.
Change in baroreflex sensitivity after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
20 men with diabetes mellitus and 20 health men will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in baroreflex sensitivity evaluated through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands).
Change in baroreflex sensitivity after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
20 men with diabetes mellitus and 20 health men will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in baroreflex sensitivity evaluated through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands).

Full Information

First Posted
June 5, 2013
Last Updated
June 7, 2016
Sponsor
Aparecida Maria Catai
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01889784
Brief Title
Acute Effect of Phototherapy With Light Emitting Diode (LED) on Muscle and Pulmonary Oxygen Consumption on Diabetes Mellitus
Official Title
Evaluation of Acute Effect of Phototherapy With Light Emitting Diode (LED) on Muscle and Pulmonary Oxygen Consumption in Patients With Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aparecida Maria Catai
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the phototherapy may be adjuvant to exercise to improve muscular efficiency and increase aerobic capacity. We hypothesized that phototherapy adjuvant with physical exercise may be benefit to populations with Diabetes mellitus that have impairment in cardiopulmonary fitness and low oxygen uptake peak values (VO2peak) in exercise tests. Two doses will be tested 150J and 300J. Additionally, this study aims to evaluate the effect of phototherapy previously applied to the exercise on the cardiovascular coupling. We hypothesize that phototherapy previously applied to the exercise will result in the increase baroreflex sensitivity (increased coherence and gain and decreased phase), promoting the improvement of the cardiovascular autonomic control and cardiovascular coupling in diabetic subjects. Two doses will be tested 150J and 300J.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes mellitus, type 2, phototherapy, physical exercise, oxygen consumption, arterial blood pressure, heart rate, baroreflex sensitivity, cardiovascular autonomic control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individuals with diabetes mellitus (phototherapy 150J)
Arm Type
Other
Arm Description
The intervention of this study is phototherapy through light emitting diode (LED) and dose of 150J each muscle. The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surae muscles bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy.
Arm Title
Health individuals - 150J (phototherapy 150J)
Arm Type
Other
Arm Description
The intervention of this study is phototherapy through light emitting diode (LED) and dose of 150J each muscle. The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surae muscle bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy.
Arm Title
Individuals with diabetes mellitus (phototherapy 300J)
Arm Type
Other
Arm Description
The intervention of this study is phototherapy through light emitting diode (LED) with 300J. The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surale muscles bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy.
Arm Title
Health individuals (phototherapy 300J)
Arm Type
Other
Arm Description
The intervention of this study is phototherapy through light emitting diode (LED). The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surae muscle bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy.
Intervention Type
Device
Intervention Name(s)
Phototherapy through light emitting diode (LED) - 150J
Intervention Description
The near-infrared radiation by light emitting diode (LED) will be performed with a cluster multi-diode arranged in an array of 34x18 cm containing 50 LEDs (GaAlAs, 850 nm). The phototherapy will be applied bilaterally on femoral quadriceps and triceps surae muscles during 40 seconds with 3J of total energy for each diode and 150 J of total energy delivery to muscle. Neither subject nor evaluators will known if LED was effective or placebo during data collection. A hidden button in the LED device is employed to ensure the double-blind procedure. This button allows selecting placebo or effective emission of near-infrared radiation while the time display is working. This button will be selected by a researcher who just participated of randomization procedure and LED application and had no access to data collection.
Intervention Type
Device
Intervention Name(s)
Placebo phototherapy - 150J
Intervention Description
The near-infrared radiation by light emitting diode (LED) will be performed with a cluster multi-diode arranged in an array of 34x18 cm containing 50 LEDs (GaAlAs, 850 nm). The phototherapy will be applied bilaterally on femoral quadriceps and triceps surae muscles during 40 seconds with 3J of total energy for each diode and 150 J of total energy delivery to muscle. Neither subject nor evaluators will known if LED was effective or placebo during data collection. A hidden button in the LED device is employed to ensure the double-blind procedure. This button allows selecting placebo or effective emission of near-infrared radiation while the time display is working. This button will be selected by a researcher who just participated of randomization procedure and LED application and had no access to data collection.
Intervention Type
Device
Intervention Name(s)
Phototherapy through light emitting diode (LED) - 300J
Intervention Description
The near-infrared radiation by light emitting diode (LED) will be performed with a cluster multi-diode arranged in an array of 34x18 cm containing 50 LEDs (GaAlAs, 850 nm). The phototherapy will be applied bilaterally on femoral quadriceps and triceps surae muscles during 80 seconds with 6J of total energy for each diode and 300 J of total energy delivery to muscle. Neither subject nor evaluators will known if LED was effective or placebo during data collection. A hidden button in the LED device is employed to ensure the double-blind procedure. This button allows selecting placebo or effective emission of near-infrared radiation while the time display is working. This button will be selected by a researcher who just participated of randomization procedure and LED application and had no access to data collection.
Intervention Type
Device
Intervention Name(s)
Placebo phototherapy - 300J
Intervention Description
The near-infrared radiation by light emitting diode (LED) will be performed with a cluster multi-diode arranged in an array of 34x18 cm containing 50 LEDs (GaAlAs, 850 nm). The phototherapy will be applied bilaterally on femoral quadriceps and triceps surae muscles during 80 seconds with 6J of total energy for each diode and 300 J of total energy delivery to muscle. Neither subject nor evaluators will known if LED was effective or placebo during data collection. A hidden button in the LED device is employed to ensure the double-blind procedure. This button allows selecting placebo or effective emission of near-infrared radiation while the time display is working. This button will be selected by a researcher who just participated of randomization procedure and LED application and had no access to data collection.
Primary Outcome Measure Information:
Title
Change in muscle oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
Description
20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in muscle oxygen uptake evaluated through near-infrared spectroscopy (NIRS) (Oxymon system, Artinis Medical Systems, Netherlands). The optode of NIRS will be fixed on quadriceps muscle in the right side.
Time Frame
Change in muscle oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Title
Change in muscle oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
Description
20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in muscle oxygen uptake evaluated through near-infrared spectroscopy (NIRS) (Oxymon system, Artinis Medical Systems, Netherlands). The optode of NIRS will be fixed on quadriceps muscle in the right side.
Time Frame
Change in muscle oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Secondary Outcome Measure Information:
Title
Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
Description
20 men with diabetes mellitus and 20 health men will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in pulmonary oxygen uptake evaluated through metabolic unit (CPX/D, MedGraphics, St. Paul, Minnesota, USA) continuously collected breath-by-breath.
Time Frame
Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Title
Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
Description
20 men with diabetes mellitus and 20 health men will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in pulmonary oxygen uptake evaluated through metabolic unit (CPX/D, MedGraphics, St. Paul, Minnesota, USA) continuously collected breath-by-breath.
Time Frame
Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Title
Change in baroreflex sensitivity after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
Description
20 men with diabetes mellitus and 20 health men will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in baroreflex sensitivity evaluated through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands).
Time Frame
Time Frame: Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Title
Change in baroreflex sensitivity after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
Description
20 men with diabetes mellitus and 20 health men will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in baroreflex sensitivity evaluated through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands).
Time Frame
Time Frame: Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Other Pre-specified Outcome Measures:
Title
Change in arterial blood pressure after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
Description
20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in arterial blood pressure evaluated continuously through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands)
Time Frame
Change in arterial blood pressure after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Title
Change in arterial blood pressure after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
Description
20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in arterial blood pressure evaluated continuously through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands)
Time Frame
Change in arterial blood pressure after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Title
Change in glucose and lactate concentrations after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
Description
20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in glucose and lactate concentrations. Blood samples will be collected by puncturing ear lobe before and 10 minutes after each exercise test had been concluded and will be processed with glucose and lactate analyser (YSI 2300 STAT PLUS - Yellow Springs Instruments - Yellow Springs, USA)
Time Frame
Change in glucose and lactate concentrations after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Title
Change in glucose and lactate concentrations after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
Description
20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in glucose and lactate concentrations. Blood samples will be collected by puncturing ear lobe before and 10 minutes after each exercise test had been concluded and will be processed with glucose and lactate analyser (YSI 2300 STAT PLUS - Yellow Springs Instruments - Yellow Springs, USA)
Time Frame
Change in glucose and lactate concentrations after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Title
Change in heart rate after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
Description
20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 40 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in heart rate evaluated continuously through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands)
Time Frame
Change in heart rate after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Title
Change in heart rate after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
Description
20 men with diabetes mellitus will receive effective-phototherapy (cluster multi-diode containing 50 LEDs applied for 80 seconds over muscle quadriceps bilaterally) or Placebo-phototherapy using the same device and procedures. Effective and placebo phototherapy will be performed 2 times each and the sequence will be random, with 14 days of rest between evaluations. The therapies will be applied 10 minutes before dynamic physical exercise of constant workload and moderate intensity to evaluate the phototherapy effect in heart rate evaluated continuously through pulse plethysmograph (Finometer PRO, Finapres Medical Systems, The Netherlands)
Time Frame
Change in heart rate after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: overt coronary disease sedentary Clinical diagnosis of diabetes mellitus Free of diabetes mellitus to participate of control group Exclusion Criteria: autonomic neuropathy Smoking anemia alcoholism disability conditions precluding exercise
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina O Francisco, Master
Phone
+55 16 91572798
Email
cristinaft05@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Renata Gonçalves, Physiotherapist
Phone
+55 16 33518705
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aparecida M Catai, pHD
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de São Carlos
City
São Carlos
State/Province
São Paulo
ZIP/Postal Code
13565-905
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina O Francisco, doctorate in progress
First Name & Middle Initial & Last Name & Degree
Aparecida M Catai, pHD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The individual data is shared with each patient. The data will be published in journal with impact in the area, but the personal information of the participants will not be uncovered.
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Acute Effect of Phototherapy With Light Emitting Diode (LED) on Muscle and Pulmonary Oxygen Consumption on Diabetes Mellitus

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