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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of Nove de Julho
Sponsor:
Information provided by (Responsible Party):
Cid André Fidelis de Paula Gomes, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT01925443
First received: June 8, 2013
Last updated: June 16, 2014
Last verified: June 2014

June 8, 2013
June 16, 2014
August 2014
December 2015   (final data collection date for primary outcome measure)
Muscle function [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Will use the isokinetic dynamometer to test and evaluate the human musculoskeletal system: peak torque and muscle fatigue of quadriceps.
Same as current
Complete list of historical versions of study NCT01925443 on ClinicalTrials.gov Archive Site
  • Muscle damage [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    Will be evaluated blood markers (creatine kinase and lactate dehydrogenase) as indirect markers of muscle damage by spectrophotometry using kits specific reagents.
  • Muscle fatigue [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The quality of life will be assessed by the questionnaire "Diabetes Quality of Life Measure"
Same as current
Not Provided
Not Provided
 
Effects of Low Power Laser Therapy on Muscle Performance Isokinetic Pre-exercise in Individuals With Diabetes Mellitus Type II
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Diabetes Mellitus Non-insulin-dependent
Other: Low level laser therapy
Will be performed irradiation with low-intensity laser in quadriceps muscle
  • 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.
    Intervention: Other: Low level laser therapy
  • 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.
    Intervention: Other: Low level laser therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
June 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact: Cid Gomes, MSc +5511970941936 cid.andre@gmail.com
Brazil
 
NCT01925443
U1111-1146-7109
Yes
Cid André Fidelis de Paula Gomes, University of Nove de Julho
University of Nove de Julho
Not Provided
Principal Investigator: Cid Gomes, MSc University of Nove de Julho
University of Nove de Julho
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP