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

NCT01925443 | Suspended DMC

• 1 other identifier: U1111-1146-7109
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Non-insulin-dependent

Keywords

diabetes mellitus non-insulin-dependent; low level laser therapy

Outcome Measures

Primary Outcomes (1)

• Muscle function

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

  2 Years

Secondary Outcomes (4)

• Muscle damage

  2 year

• Muscle fatigue

  2 years

• Functionality

  2 years

• Quality of life

  2 years

Study Arms (3)

low level laser therapy

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Placebo group

EXPERIMENTAL

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

Other: Low level laser therapy

Interventions

Low level laser therapy OTHER

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

Placebo group; low level laser therapy

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis for Diabetes mellitus non-insulin-dependent
• Age between 30 to 70 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho

São Paulo, São Paulo, 01504-001, Brazil

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Cid Gomes, MSc

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2013
• First Posted: August 19, 2013
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

BR (1)