search
Back to results

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

Primary Purpose

Diabetes Mellitus Non-insulin-dependent

Status
Suspended
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low level laser therapy
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Non-insulin-dependent focused on measuring diabetes mellitus non-insulin-dependent, low level laser therapy

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nove de Julho

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

low level laser therapy

Control Group

Placebo group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Muscle function
Will use the isokinetic dynamometer to test and evaluate the human musculoskeletal system: peak torque and muscle fatigue of quadriceps.

Secondary Outcome Measures

Muscle damage
Will be evaluated blood markers (creatine kinase and lactate dehydrogenase) as indirect markers of muscle damage by spectrophotometry using kits specific reagents.
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).
Functionality
Functionality will be evaluated using the following assessment tools: Stand and sit test, Six-minute walk test, and Lower Extremity Functional Scale.
Quality of life
The quality of life will be assessed by the questionnaire "Diabetes Quality of Life Measure"

Full Information

First Posted
June 8, 2013
Last Updated
December 2, 2015
Sponsor
University of Nove de Julho
search

1. Study Identification

Unique Protocol Identification Number
NCT01925443
Brief Title
Effects of Low Power Laser Therapy on Muscle Performance Isokinetic Pre-exercise in Individuals With Diabetes Mellitus Type II
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Suspended
Why Stopped
technical problems with equipment from the main outcome
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Non-insulin-dependent
Keywords
diabetes mellitus non-insulin-dependent, low level laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low level laser therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
will consist of individuals diagnosed with diabetes mellitus non-insulin-dependent, however, will not perform low level laser therapy, participate only in the evaluations
Arm Title
Placebo group
Arm Type
Experimental
Arm Description
individuals will be subject to the application of low level laser therapy but with a dose of 0 Joules.
Intervention Type
Other
Intervention Name(s)
Low level laser therapy
Intervention Description
Will be performed irradiation with low-intensity laser in quadriceps muscle
Primary Outcome Measure Information:
Title
Muscle function
Description
Will use the isokinetic dynamometer to test and evaluate the human musculoskeletal system: peak torque and muscle fatigue of quadriceps.
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Muscle damage
Description
Will be evaluated blood markers (creatine kinase and lactate dehydrogenase) as indirect markers of muscle damage by spectrophotometry using kits specific reagents.
Time Frame
2 year
Title
Muscle fatigue
Description
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).
Time Frame
2 years
Title
Functionality
Description
Functionality will be evaluated using the following assessment tools: Stand and sit test, Six-minute walk test, and Lower Extremity Functional Scale.
Time Frame
2 years
Title
Quality of life
Description
The quality of life will be assessed by the questionnaire "Diabetes Quality of Life Measure"
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cid Gomes, MSc
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nove de Julho
City
São Paulo
ZIP/Postal Code
01504-001
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.uninove.br
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs