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

December 2, 2015 updated by: Cid André Fidelis de Paula Gomes, University of Nove de Julho
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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01504-001
        • University of Nove de Julho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Low level laser therapy
Will be performed irradiation with low-intensity laser in quadriceps muscle
No Intervention: 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
Experimental: Placebo group
individuals will be subject to the application of low level laser therapy but with a dose of 0 Joules.
Other: Low level laser therapy
Will be performed irradiation with low-intensity laser in quadriceps muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle function
Time Frame: 2 Years
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
Time Frame: 2 year
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
The quality of life will be assessed by the questionnaire "Diabetes Quality of Life Measure"
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nove de Julho

Investigators

  • Principal Investigator: Cid Gomes, MSc, University of Nove de Julho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

June 8, 2013

First Submitted That Met QC Criteria

August 15, 2013

First Posted (Estimate)

August 19, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1146-7109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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