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
  Purpose

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.


Condition Intervention
Diabetes Mellitus Non-insulin-dependent
Other: Low level laser therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Nove de Julho:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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"


Estimated Enrollment: 60
Study Start Date: August 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01925443

Contacts
Contact: Cid Gomes, MSc +5511970941936 cid.andre@gmail.com

Locations
Brazil
University of Nove de Julho Not yet recruiting
São Paulo, Brazil, 01504-001
Contact: Cid Gomes, MSc    +5511970941936    cid.andre@gmail.com   
Principal Investigator: Cid Gomes, MSc         
Sponsors and Collaborators
University of Nove de Julho
Investigators
Principal Investigator: Cid Gomes, MSc University of Nove de Julho
  More Information

Additional Information:
No publications provided

Responsible Party: Cid André Fidelis de Paula Gomes, Professor, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT01925443     History of Changes
Other Study ID Numbers: U1111-1146-7109
Study First Received: June 8, 2013
Last Updated: June 16, 2014
Health Authority: Brazil: Associação Fundo de Incentivo à Pesquisa
Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by University of Nove de Julho:
diabetes mellitus non-insulin-dependent
low level laser therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 02, 2014