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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02688426
• Other study ID #: LLLT-CABG-2016/1
• Status: Recruiting
• Phase: N/A
• First received: February 18, 2016
• Last updated: March 21, 2016
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: March 2016
• Source: Federal University of Health Science of Porto Alegre
• Contact: Rodrigo Plentz, PhD
• Phone: +55 51 33038835
• Email: roplentz[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• Sham Low-Level Laser Therapy (Sham LLLT)
perform with the machine off
• 6J Low-Level Laser Therapy (6J LLLT)
irradiation will be perform with 6J

Locations

Country	Name	City	State
Brazil	Rodrigo Della Méa Plentz	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute walk test		up to 2 weeks	No
Secondary	Muscle damage	The damage to DNA is analyzed by electrophoresis single (comet technique), where cells are counted by microscopy.	up to 2 weeks	No
Secondary	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	No