Effects of Low Power Laser Therapy on Muscle Performance Isokinetic Pre-exercise in Individuals With Diabetes Mellitus Type II

Study Overview
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Brief Summary
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The low level laser therapy is able to improve immediately and long term (after 4 weeks of treatment, 3 days per week resulting in 12 applications of low level laser therapy) isokinetic muscle performance of the quadriceps femoris muscle (peak torque, total muscular work , maximum power and fatigue index - normalized by body weight) pre-exercise concentric isokinetic quadriceps femoris muscle in subjects with diabetes mellitus non-insulin-dependent.

Detailed Description
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The low level laser therapy is able to improve after 4 weeks of treatment, 3 days per week resulting in 12 applications of low level laser therapy, the indicators: The low level laser therapy is able to improve immediately and long term (after 4 weeks of treatment, 3 days per week resulting in 12 applications of low level laser therapy), the indirect blood markers for muscle damage that evaluate the enzymatic activity of creatine Kinase (CK) and Lactate Dehydrogenase (LDH) and the visual analog scale (VAS-F) for fatigue, improves indicators F 2.2 point of the WHOQOL-100 for fatigue, improvement in functional indicators of the lower lower Extremity functional regarding Scale, functional improvement in performance in the execution of the test stand and sit and walk test six minutes, the indicators for quality improvement of life questionnaire for the Diabetes Quality of Life Measure and emotional states through the questionnaire Problems Areas in Diabetes Scale. Eligibility criteria: Diagnosis for Diabetes mellitus non-insulin-dependent confirmed by the individual physician, presenting between 30 to 70 years.Exclusion criteria: Diagnosis of cardiovascular disorders, diagnosis of diabetic neuropathy, which have a skin lesion or local infection (quadriceps), history of musculoskeletal injuries in the last 6 months or during the study, individuals unable to perform the assessment protocols / exercise so satisfactory, those who are doing some kind of regular physical activity and who underwent alcohol intake in the 24 hours before any of the stages of the study.

Conditions
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Diabetes Mellitus Non-insulin-dependent

Intervention / Treatment
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* Other: Low level laser therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis for Diabetes mellitus non-insulin-dependent Age between 30 to 70 years Exclusion Criteria: Diagnosis of cardiovascular disorders Diagnosis of diabetic neuropathy, Skin lesion or local infection (quadriceps) History of musculoskeletal injuries in the last 6 months or during the study Individuals unable to perform the assessment protocols or exercise Regular physical activity Underwent alcohol intake in the 24 hours before any of the stages of the study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low level laser therapy<br>individuals will be subject to the application of low level laser therapy, but this group will have three subdivisions related to dose in joules that will be administered to the individual, and J 4, J 6, 8 J. To be administered in the quadriceps muscle. | Other: Low level laser therapy<br>* Will be performed irradiation with low-intensity laser in quadriceps muscle<br>|
| No Intervention: Control Group<br>will consist of individuals diagnosed with diabetes mellitus non-insulin-dependent, however, will not perform low level laser therapy, participate only in the evaluations | |
| Experimental: Placebo group<br>individuals will be subject to the application of low level laser therapy but with a dose of 0 Joules. | Other: Low level laser therapy<br>* Will be performed irradiation with low-intensity laser in quadriceps muscle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle function | Will use the isokinetic dynamometer to test and evaluate the human musculoskeletal system: peak torque and muscle fatigue of quadriceps. | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle damage | Will be evaluated blood markers (creatine kinase and lactate dehydrogenase) as indirect markers of muscle damage by spectrophotometry using kits specific reagents. | 2 year | 
| Muscle fatigue | In order to assess self-perceived fatigue in day-to-day and immediately after the fatigue protocol will be used two instruments: a visual analog scale (VAS-F) and the question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100). | 2 years | 
| Functionality | Functionality will be evaluated using the following assessment tools: Stand and sit test, Six-minute walk test, and Lower Extremity Functional Scale. | 2 years | 
| Quality of life | The quality of life will be assessed by the questionnaire Diabetes Quality of Life Measure | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus non-insulin-dependent, low level laser therapy