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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Device: Sham Low-Level Laser Therapy (Sham LLLT); Device: 6J Low-Level Laser Therapy (6J LLLT)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90050-170
      • Recruiting
      • Rodrigo Della Méa Plentz
      • Contact: Rodrigo Della Méa Plentz, PhD; Phone Number: +55 51 33038835; Email: roplentz@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 0J LLLT; 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); perform with the machine off; Other Names: Sham LLLT; Device: 6J Low-Level Laser Therapy (6J LLLT); irradiation will be perform with 6J; Other Names: 6J
Experimental: 6J LLLT; The Laser radiation will be made with 6J by spot.	Device: Sham Low-Level Laser Therapy (Sham LLLT); perform with the machine off; Other Names: Sham LLLT; Device: 6J Low-Level Laser Therapy (6J LLLT); irradiation will be perform with 6J; Other Names: 6J

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre

Publications and helpful links

General Publications

• Stein C, Fernandes RO, Miozzo AP, Coronel CC, Baroni BM, Bello-Klein A, Plentz RDM. Acute Effects of Low-Level Laser Therapy on Patients' Functional Capacity in the Postoperative Period of Coronary Artery Bypass Graft Surgery: A Randomized, Crossover, Placebo-Controlled Trial. Photomed Laser Surg. 2018 Mar;36(3):122-129. doi: 10.1089/pho.2017.4270. Epub 2018 Feb 21.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Estimate): March 23, 2016
• Last Update Submitted That Met QC Criteria: March 21, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: LLLT-CABG-2016/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No