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

NCT02688426 | Unknown

• 1 other identifier: LLLT-CABG-2016/1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Six-minute walk test

  up to 2 weeks

Secondary Outcomes (2)

• Muscle damage

  up to 2 weeks

• Oxidative stress

  up to 2 weeks

Study Arms (2)

0J LLLT

SHAM COMPARATOR

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); Device: 6J Low-Level Laser Therapy (6J LLLT)

6J LLLT

EXPERIMENTAL

The Laser radiation will be made with 6J by spot.

Device: Sham Low-Level Laser Therapy (Sham LLLT); Device: 6J Low-Level Laser Therapy (6J LLLT)

Interventions

Sham Low-Level Laser Therapy (Sham LLLT) DEVICE

perform with the machine off

Also known as: Sham LLLT

0J LLLT; 6J LLLT

6J Low-Level Laser Therapy (6J LLLT) DEVICE

irradiation will be perform with 6J

Also known as: 6J

0J LLLT; 6J LLLT

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Rodrigo Della Méa Plentz

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 29466116 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Rodrigo Plentz, PhD

CONTACT

+55 51 33038835; roplentz@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 23, 2016
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 23, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)