Acute Effect of Phototherapy With Light Emitting Diode (LED) on Muscle and Pulmonary Oxygen Consumption on Diabetes Mellitus
Evaluation of Acute Effect of Phototherapy With Light Emitting Diode (LED) on Muscle and Pulmonary Oxygen Consumption in Patients With Diabetes Mellitus
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes-mellitus
Started Aug 2013
Longer than P75 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2013
CompletedFirst Posted
Study publicly available on registry
June 28, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJune 8, 2016
June 1, 2016
3.3 years
June 5, 2013
June 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 initial, 2 weeks, 4 weeks and 6 weeks
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.
Change in muscle oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Secondary Outcomes (4)
Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Change in baroreflex sensitivity after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
Time Frame: Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Change in baroreflex sensitivity after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
Time Frame: Change in pulmonary oxygen uptake after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Other Outcomes (6)
Change in arterial blood pressure after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
Change in arterial blood pressure after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Change in arterial blood pressure after phototherapy and placebo phototherapy with light emitting diode (LED) - 300J
Change in arterial blood pressure after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
Change in glucose and lactate concentrations after phototherapy and placebo phototherapy with light emitting diode (LED) - 150J
Change in glucose and lactate concentrations after phototherapy and placebo phototherapy initial, 2 weeks, 4 weeks and 6 weeks
- +3 more other outcomes
Study Arms (4)
Individuals with diabetes mellitus (phototherapy 150J)
OTHERThe 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.
Health individuals - 150J (phototherapy 150J)
OTHERThe 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.
Individuals with diabetes mellitus (phototherapy 300J)
OTHERThe 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.
Health individuals (phototherapy 300J)
OTHERThe 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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- overt coronary disease
- sedentary
- Clinical diagnosis of diabetes mellitus
- Free of diabetes mellitus to participate of control group
You may not qualify if:
- autonomic neuropathy
- Smoking
- anemia
- alcoholism
- disability conditions precluding exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal de São Carlos
São Carlos, São Paulo, 13565-905, Brazil
Related Publications (9)
Vieira WH, Ferraresi C, Perez SE, Baldissera V, Parizotto NA. Effects of low-level laser therapy (808 nm) on isokinetic muscle performance of young women submitted to endurance training: a randomized controlled clinical trial. Lasers Med Sci. 2012 Mar;27(2):497-504. doi: 10.1007/s10103-011-0984-0. Epub 2011 Aug 26.
PMID: 21870127BACKGROUNDLeal Junior EC, Lopes-Martins RA, Vanin AA, Baroni BM, Grosselli D, De Marchi T, Iversen VV, Bjordal JM. Effect of 830 nm low-level laser therapy in exercise-induced skeletal muscle fatigue in humans. Lasers Med Sci. 2009 May;24(3):425-31. doi: 10.1007/s10103-008-0592-9. Epub 2008 Jul 23.
PMID: 18649044BACKGROUNDPaolillo FR, Milan JC, Aniceto IV, Barreto SG, Rebelatto JR, Borghi-Silva A, Parizotto NA, Kurachi C, Bagnato VS. Effects of infrared-LED illumination applied during high-intensity treadmill training in postmenopausal women. Photomed Laser Surg. 2011 Sep;29(9):639-45. doi: 10.1089/pho.2010.2961. Epub 2011 Jul 12.
PMID: 21749263BACKGROUNDLeal Junior EC, Lopes-Martins RA, Rossi RP, De Marchi T, Baroni BM, de Godoi V, Marcos RL, Ramos L, Bjordal JM. Effect of cluster multi-diode light emitting diode therapy (LEDT) on exercise-induced skeletal muscle fatigue and skeletal muscle recovery in humans. Lasers Surg Med. 2009 Oct;41(8):572-7. doi: 10.1002/lsm.20810.
PMID: 19731300BACKGROUNDIhsan FR. Low-level laser therapy accelerates collateral circulation and enhances microcirculation. Photomed Laser Surg. 2005 Jun;23(3):289-94. doi: 10.1089/pho.2005.23.289.
PMID: 15954817BACKGROUNDVladimirov YA, Osipov AN, Klebanov GI. Photobiological principles of therapeutic applications of laser radiation. Biochemistry (Mosc). 2004 Jan;69(1):81-90. doi: 10.1023/b:biry.0000016356.93968.7e.
PMID: 14972023BACKGROUNDBauer TA, Reusch JE, Levi M, Regensteiner JG. Skeletal muscle deoxygenation after the onset of moderate exercise suggests slowed microvascular blood flow kinetics in type 2 diabetes. Diabetes Care. 2007 Nov;30(11):2880-5. doi: 10.2337/dc07-0843. Epub 2007 Aug 3.
PMID: 17675540BACKGROUNDWilkerson DP, Poole DC, Jones AM, Fulford J, Mawson DM, Ball CI, Shore AC. Older type 2 diabetic males do not exhibit abnormal pulmonary oxygen uptake and muscle oxygen utilization dynamics during submaximal cycling exercise. Am J Physiol Regul Integr Comp Physiol. 2011 Mar;300(3):R685-92. doi: 10.1152/ajpregu.00479.2010. Epub 2010 Dec 22.
PMID: 21178129BACKGROUNDFrancisco Cde O, Beltrame T, Ferraresi C, Parizotto NA, Bagnato VS, Borghi Silva A, Benze BG, Porta A, Catai AM. Evaluation of acute effect of light-emitting diode (LED) phototherapy on muscle deoxygenation and pulmonary oxygen uptake kinetics in patients with diabetes mellitus: study protocol for a randomized controlled trial. Trials. 2015 Dec 15;16:572. doi: 10.1186/s13063-015-1093-3.
PMID: 26666374DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aparecida M Catai, pHD
Universidade Federal de Sao Carlos
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
June 5, 2013
First Posted
June 28, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2016
Study Completion
June 1, 2017
Last Updated
June 8, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share
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.