Clinical trial NCT01925443: Effects of Low Power Laser Therapy on Muscle Performance Isokinetic Pre-exercise in Individuals With Diabetes Mellitus Type II
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Diabetes Mellitus Non-insulin-dependent
Keywords: diabetes mellitus non-insulin-dependent
low level laser therapy
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2013-08-19
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle function
timeFrame: 2 Years
Secondary outcomes:
measure: Muscle damage
timeFrame: 2 year
measure: Muscle fatigue
timeFrame: 2 years
measure: Functionality
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Cid Gomes, MSc
role: PRINCIPAL_INVESTIGATOR
References: