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

NCT ID: NCT01925443

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-06-30

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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low level laser therapy

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.

Group Type EXPERIMENTAL

Low level laser therapy

Intervention Type OTHER

Will be performed irradiation with low-intensity laser in quadriceps muscle

Control Group

will consist of individuals diagnosed with diabetes mellitus non-insulin-dependent, however, will not perform low level laser therapy, participate only in the evaluations

Group Type NO_INTERVENTION

No interventions assigned to this group

Placebo group

individuals will be subject to the application of low level laser therapy but with a dose of 0 Joules.

Group Type EXPERIMENTAL

Low level laser therapy

Intervention Type OTHER

Will be performed irradiation with low-intensity laser in quadriceps muscle

Interventions

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Low level laser therapy

Will be performed irradiation with low-intensity laser in quadriceps muscle

Intervention Type OTHER

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Cid André Fidelis de Paula Gomes

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cid Gomes, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

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University of Nove de Julho

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Related Links

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Other Identifiers

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U1111-1146-7109

Identifier Type: -

Identifier Source: org_study_id