Effects of the Low-level Laser Therapy on Functional Capacity of the Patients With Coronary Artery Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
The low-level laser therapy (LLLT) has been used in many inflammatory disorders. More recently the LLLT was associated with an improvement in the muscle strength, endurance and functional capacity.But, these effects were described only in health or athletic individuals. In this randomized and controlled clinical trails, the investigators will study the effects of LLLT on functional capacity of the patients with Coronary artery bypass surgery.

Detailed Description
-----------------
This study will be conducing in a large hospital that is reference in Coronary artery bypass surgery. 15 patients will be randomized for placebo or low-level laser therapy (LLLT). The functional capacity will be test by test six-minute walk test before and after de LLLT. Moreover the application of LBP or placebo will be followed by assessments of muscle damage and oxidative stress. One-week interval between the LLLT will gave to reduce the influence between the treatments.

Official Title
-----------------
Effects Acute of the Low-level Laser Therapy on Functional Capacity on Patients With Coronary Artery Bypass Surgery : A Randomized, Controlled Clinical Trail

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Device: Sham Low-Level Laser Therapy (Sham LLLT)
* Device: 6J Low-Level Laser Therapy (6J LLLT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the postoperative period of elective CABG referred for cardiac rehabilitation, which are the 15th and 30th days after surgery without ischemic changes and / or complex arrhythmias on the electrocardiogram, between 40 and 75 years of age who have performed the first surgery. Exclusion Criteria: Patients with decompensated heart failure; presence of any comorbidity such as: unstable angina; associated neurological disease; moderate respiratory illness to severe pre-diagnosed by the attending physician; active infectious disease or fever; disabling peripheral vascular disease; unstable ventricular arrhythmias; diabetes mellitus; use of cardiac pacemaker, musculoskeletal disease that limits physical activity, patients with a BMI ≥30.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 0J LLLT<br>The sham treatment is performed in the same way as treatment with LBP, however, with the apparatus switched off | Device: Sham Low-Level Laser Therapy (Sham LLLT)<br>* perform with the machine off<br>* Other names: Sham LLLT;Device: 6J Low-Level Laser Therapy (6J LLLT)<br>* irradiation will be perform with 6J<br>* Other names: 6J;|
| Experimental: 6J LLLT<br>The Laser radiation will be made with 6J by spot. | Device: Sham Low-Level Laser Therapy (Sham LLLT)<br>* perform with the machine off<br>* Other names: Sham LLLT;Device: 6J Low-Level Laser Therapy (6J LLLT)<br>* irradiation will be perform with 6J<br>* Other names: 6J;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walk test |  | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle damage | The damage to DNA is analyzed by electrophoresis single (comet technique), where cells are counted by microscopy. | up to 2 weeks | 
| Oxidative stress | Oxidative stress will be used a measure of tissue damage, the protein oxidation (method of carbonyls) and two defense measures, an enzyme superoxide dismutase and total antioxidant capacity. Oxidative damage (nmol / mg) of protein carbonylation was determined according to the method proposed by Levine & Stadtman, 1990, using whole blood. The enzymatic activity of SOD (SOD / mg protein) was determined by the inhibition of autooxidation of adrenaline measured spectrophotometrically (480nm) under Bannister and Calabrese (1987). | up to 2 weeks |